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Trial record 1 of 1 for:    THRIVE-AA2
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Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (THRIVE-AA2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04797650
Recruitment Status : Completed
First Posted : March 15, 2021
Results First Posted : July 3, 2023
Last Update Posted : July 3, 2023
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alopecia Areata
Interventions Drug: CTP-543 matching placebo
Drug: CTP-543
Enrollment 517
Recruitment Details Participants were enrolled at study centers in Canada, France, Germany, Hungary, Poland, Spain and the United States from 10 June 2021 to 29 June 2022.
Pre-assignment Details 671 participants were screened, out of which 517 participants who experienced moderate to severe hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks. Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Period Title: Overall Study
Started 130 258 129
Efficacy Population [1] 127 249 127
Safety Population [2] 130 256 129
Completed 119 233 120
Not Completed 11 25 9
Reason Not Completed
Reason Not Specified             5             12             5
Treatment Emergent or Worsening Adverse Event             1             7             0
Lack of Efficacy             1             0             1
Non-compliance with Study Drug             0             0             2
Lost to Follow-up             4             6             1
[1]
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
[2]
Safety population included all participants who received study drug during the treatment period
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID Total
Hide Arm/Group Description Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 130 258 129 517
Hide Baseline Analysis Population Description
All randomized participants included all participants who were randomized in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 258 participants 129 participants 517 participants
39.7  (12.49) 38.4  (12.30) 39.7  (12.90) 39.0  (12.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 258 participants 129 participants 517 participants
Female
88
  67.7%
177
  68.6%
84
  65.1%
349
  67.5%
Male
42
  32.3%
81
  31.4%
45
  34.9%
168
  32.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 258 participants 129 participants 517 participants
Hispanic or Latino
11
   8.5%
23
   8.9%
9
   7.0%
43
   8.3%
Not Hispanic or Latino
108
  83.1%
205
  79.5%
111
  86.0%
424
  82.0%
Unknown or Not Reported
11
   8.5%
30
  11.6%
9
   7.0%
50
   9.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 130 participants 258 participants 129 participants 517 participants
American Indian or Alaska Native
1
   0.8%
5
   1.9%
0
   0.0%
6
   1.2%
Asian
7
   5.4%
4
   1.6%
4
   3.1%
15
   2.9%
Black or African American
10
   7.7%
17
   6.6%
7
   5.4%
34
   6.6%
White
100
  76.9%
203
  78.7%
109
  84.5%
412
  79.7%
Other
1
   0.8%
1
   0.4%
0
   0.0%
2
   0.4%
Not reported
11
   8.5%
28
  10.9%
9
   7.0%
48
   9.3%
1.Primary Outcome
Title Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
Hide Description SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: Percentage of participants
0.8 33.0 38.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.25 to 0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.031
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.27 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.044
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Hide Description SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Responders were defined as participants with responses of "satisfied" or "very satisfied".
Time Frame Weeks 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: Percentage of responders
Week 12 4.9 43.2 41.0
Week 16 4.9 41.0 45.1
Week 20 1.7 40.1 52.5
Week 24 1.7 46.5 51.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.31 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.038
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.26 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.049
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.30 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.037
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.31 to 0.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.049
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.32 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.034
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.41 to 0.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.047
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.38 to 0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.035
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.40 to 0.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.047
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Hide Description SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time Frame Weeks 4, 8, 12, 16, and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 0 0.4 0
Week 8 0.8 2.9 2.4
Week 12 0.8 10.5 12.3
Week 16 0.8 20.2 21.1
Week 20 0.8 24.8 28.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3175
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.00 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.004
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1020
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.00 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.013
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3103
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.01 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.016
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.06 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.021
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.06 to 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.14 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.026
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.13 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.037
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
0.18 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.028
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
0.19 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.041
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Hide Description SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measures. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo BID CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 125 242 125
Mean (Standard Deviation)
Unit of Measure: percentage change
Relative Change From Baseline at Week 4 Number Analyzed 124 participants 242 participants 124 participants
0.4  (5.40) -2.6  (10.10) -3.2  (9.45)
Relative Change From Baseline at Week 8 Number Analyzed 125 participants 239 participants 125 participants
-2.0  (13.41) -11.5  (20.63) -16.4  (23.92)
Relative Change From Baseline at Week 12 Number Analyzed 123 participants 237 participants 122 participants
-0.7  (14.72) -23.9  (29.06) -30.3  (31.85)
Relative Change From Baseline at Week 16 Number Analyzed 124 participants 238 participants 123 participants
0.9  (13.19) -34.3  (34.93) -39.9  (35.43)
Relative Change From Baseline at Week 20 Number Analyzed 120 participants 234 participants 118 participants
0.4  (15.49) -38.9  (37.64) -47.7  (37.62)
Relative Change From Baseline at Week 24 Number Analyzed 119 participants 233 participants 120 participants
1.6  (16.54) -44.6  (39.58) -52.7  (38.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 8 mg BID
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-4.7 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 12 mg BID
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.6 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 8 mg BID
Comments Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.4
Confidence Interval (2-Sided) 95%
-13.6 to -5.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 12 mg BID
Comments Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -14.2
Confidence Interval (2-Sided) 95%
-19 to -9.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -23
Confidence Interval (2-Sided) 95%
-28.8 to -17.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -29.3
Confidence Interval (2-Sided) 95%
-35.9 to -22.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -34.8
Confidence Interval (2-Sided) 95%
-41.4 to -28.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -40.2
Confidence Interval (2-Sided) 95%
-47.8 to -32.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -38.7
Confidence Interval (2-Sided) 95%
-45.9 to -31.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -46.6
Confidence Interval (2-Sided) 95%
-54.8 to -38.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -45.9
Confidence Interval (2-Sided) 95%
-53.4 to -38.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo BID, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -52.8
Confidence Interval (2-Sided) 95%
-61.4 to -44.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.36
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
Hide Description The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
Time Frame Weeks 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: Percentage of responders
Week 12 3.3 38.0 44.3
Week 16 3.2 45.0 52.0
Week 20 1.7 50.0 59.0
Week 24 2.5 54.1 61.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Hide Description The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
Time Frame Weeks 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: Percentage of responders
Week 12 3.3 43.3 49.2
Week 16 4.0 46.2 59.8
Week 20 5.8 48.7 64.4
Week 24 1.7 50.9 68.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Hide Description The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Time Frame Baseline, Weeks 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 123 236 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 123 participants 236 participants 124 participants
6.4  (0.82) 6.5  (0.83) 6.4  (0.76)
Change From Baseline at Week 12 Number Analyzed 121 participants 232 participants 122 participants
0.0  (0.75) -1.3  (1.45) -1.5  (1.52)
Change From Baseline at Week 16 Number Analyzed 122 participants 234 participants 123 participants
0.1  (0.67) -1.6  (1.61) -1.8  (1.69)
Change From Baseline at Week 20 Number Analyzed 118 participants 231 participants 118 participants
-0.0  (0.96) -1.8  (1.80) -2.2  (1.83)
Change From Baseline at Week 24 Number Analyzed 117 participants 229 participants 120 participants
0.1  (0.79) -2.1  (1.97) -2.4  (1.96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.5 to -1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-1.7 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-1.9 to -1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.2 to -1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2 to -1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-2.5 to -1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-2.5 to -1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-2.8 to -2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Hide Description The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1= normal, no hair loss; 2= borderline hair loss; 3= mild hair loss; 4= moderate hair loss; 5= marked hair loss; 6= severe hair loss; 7= among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Time Frame Baseline, Weeks 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 124 236 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 124 participants 236 participants 124 participants
6.7  (0.64) 6.6  (0.79) 6.5  (0.78)
Change From Baseline at Week 12 Number Analyzed 122 participants 234 participants 122 participants
-0.2  (0.97) -1.6  (2.05) -1.8  (1.88)
Change From Baseline at Week 16 Number Analyzed 123 participants 234 participants 122 participants
-0.2  (1.06) -1.8  (2.10) -2.0  (1.90)
Change From Baseline at Week 20 Number Analyzed 119 participants 232 participants 118 participants
-0.3  (1.26) -2.0  (2.20) -2.2  (1.91)
Change From Baseline at Week 24 Number Analyzed 118 participants 228 participants 120 participants
-0.2  (1.04) -2.3  (2.26) -2.5  (1.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-1.8 to -1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.3 to -1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.2 to -1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.4 to -1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-2.5 to -1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-2.8 to -1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
Hide Description SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.
Time Frame Baseline, Weeks 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: Percentage of participants
75% Relative Reduction: Week 12 0 8.9 11.5
75% Relative Reduction: Week 24 0 33.5 38.3
90% Relative Reduction: Week 12 0 1.7 4.9
90% Relative Reduction: Week 24 0 21.9 25.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments 75% Relative Reduction: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
0.05 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.018
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments 75% Relative Reduction: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.06 to 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.029
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments 75% Relative Reduction: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.27 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments 75% Relative Reduction: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.28 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments 90% Relative Reduction: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0409
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
0.00 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.009
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments 90% Relative Reduction: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
0.01 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.019
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments 90% Relative Reduction: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.16 to 0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.026
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments 90% Relative Reduction: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.16 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.038
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
Hide Description BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0= no eyebrow, 1= minimal eyebrow, 2= moderate eyebrow, and 3= normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.
Time Frame Baseline, Weeks 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 95 173 90
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 95 participants 173 participants 90 participants
0.9  (1.64) 0.7  (1.44) 1.1  (1.65)
Change From Baseline at Week 12 Number Analyzed 88 participants 157 participants 80 participants
-0.3  (0.93) 0.8  (1.53) 0.7  (1.66)
Change From Baseline at Week 24 Number Analyzed 86 participants 156 participants 83 participants
-0.3  (1.1) 1.2  (1.76) 1.2  (1.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
0.7 to 1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.7 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1.1 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.3 to 2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
Hide Description BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.
Time Frame Baseline, Weeks 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 85 165 82
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 85 participants 165 participants 82 participants
0.7  (1.38) 0.9  (1.68) 1.1  (1.83)
Change From Baseline at Week 12 Number Analyzed 84 participants 156 participants 81 participants
-0.1  (0.91) 0.9  (1.60) 1.0  (1.76)
Change From Baseline at Week 24 Number Analyzed 78 participants 153 participants 69 participants
-0.0  (0.93) 1.4  (2.09) 1.3  (1.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.7 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.7 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1 to 2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Hide Description SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.
Time Frame Baseline, Weeks 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 124 236 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 124 participants 236 participants 124 participants
4.5  (0.85) 4.6  (0.71) 4.6  (0.80)
Change From Baseline at Week 12 Number Analyzed 122 participants 234 participants 122 participants
-0.4  (1.14) -1.6  (1.39) -1.7  (1.33)
Change From Baseline at Week 16 Number Analyzed 123 participants 234 participants 122 participants
-0.1  (1.10) -1.6  (1.31) -1.7  (1.36)
Change From Baseline at Week 20 Number Analyzed 119 participants 232 participants 118 participants
-0.1  (0.97) -1.5  (1.40) -1.9  (1.38)
Change From Baseline at Week 24 Number Analyzed 118 participants 228 participants 120 participants
-0.1  (0.93) -1.6  (1.47) -1.9  (1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.4 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.5 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-1.6 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-1.8 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-1.6 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2 to -1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-1.8 to -1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.1 to -1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
Hide Description SPRO is a questionnaire answered by the participants and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.
Time Frame Weeks 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: Percentage of participants
Week 12 15.6 50.4 59.0
Week 16 9.8 52.6 57.4
Week 20 9.2 50.4 63.6
Week 24 8.5 52.6 61.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.25 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.046
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.33 to 0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.055
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.35 to 0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.042
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.37 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.052
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.34 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.041
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.44 to 0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.36 to 0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.041
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.42 to 0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.051
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Hide Description The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Time Frame Baseline, Weeks 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 124 236 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Satisfied Thickness Hair Coverage: Baseline Number Analyzed 124 participants 236 participants 124 participants
4.6  (0.76) 4.6  (0.66) 4.6  (0.83)
Satisfied Thickness Hair Coverage: Change From Baseline at Week 12 Number Analyzed 122 participants 234 participants 122 participants
-0.3  (0.95) -1.3  (1.20) -1.4  (1.35)
Satisfied Thickness Hair Coverage: Change From Baseline at Week 16 Number Analyzed 123 participants 234 participants 122 participants
-0.1  (0.91) -1.3  (1.23) -1.5  (1.30)
Satisfied Thickness Hair Coverage: Change From Baseline at Week 20 Number Analyzed 119 participants 232 participants 118 participants
-0.1  (0.85) -1.3  (1.35) -1.7  (1.36)
Satisfied Thickness Hair Coverage: Change From Baseline at Week 24 Number Analyzed 118 participants 228 participants 120 participants
-0.1  (0.89) -1.4  (1.46) -1.6  (1.41)
Satisfied evenness hair coverage: Baseline Number Analyzed 124 participants 236 participants 124 participants
4.7  (0.61) 4.7  (0.58) 4.7  (0.74)
Satisfied evenness hair coverage: Change From Baseline at Week 12 Number Analyzed 122 participants 234 participants 122 participants
-0.3  (0.78) -1.2  (1.10) -1.3  (1.26)
Satisfied evenness hair coverage: Change From Baseline at Week 16 Number Analyzed 123 participants 234 participants 122 participants
-0.2  (0.82) -1.1  (1.12) -1.3  (1.20)
Satisfied evenness hair coverage: Change From Baseline at Week 20 Number Analyzed 119 participants 232 participants 118 participants
-0.1  (0.76) -1.3  (1.27) -1.5  (1.29)
Satisfied evenness hair coverage: Change From Baseline at Week 24 Number Analyzed 118 participants 228 participants 120 participants
-0.1  (0.71) -1.4  (1.36) -1.6  (1.37)
How satisfied with your eyebrows: Baseline Number Analyzed 124 participants 236 participants 124 participants
4.3  (1.07) 4.3  (1.16) 4.1  (1.32)
How satisfied with your eyebrows: Change From Baseline at Week 12 Number Analyzed 122 participants 234 participants 122 participants
-0.2  (0.84) -1.3  (1.31) -1.3  (1.42)
How satisfied with your eyebrows: Change From Baseline at Week 16 Number Analyzed 123 participants 234 participants 122 participants
-0.2  (0.78) -1.2  (1.28) -1.4  (1.54)
How satisfied with your eyebrows: Change From Baseline at Week 20 Number Analyzed 119 participants 232 participants 118 participants
-0.1  (0.78) -1.4  (1.40) -1.4  (1.47)
How satisfied with your eyebrows: Change From Baseline at Week 24 Number Analyzed 118 participants 228 participants 120 participants
-0.1  (0.81) -1.4  (1.43) -1.6  (1.50)
How satisfied with your eyelashes: Baseline Number Analyzed 124 participants 236 participants 124 participants
4.1  (1.23) 4.1  (1.32) 3.8  (1.42)
How satisfied with your eyelashes: Change From Baseline at Week 12 Number Analyzed 122 participants 234 participants 122 participants
-0.2  (0.72) -1.1  (1.34) -1.0  (1.29)
How satisfied with your eyelashes: Change From Baseline at Week 16 Number Analyzed 123 participants 234 participants 122 participants
-0.2  (0.82) -1.1  (1.29) -1.1  (1.41)
How satisfied with your eyelashes: Change From Baseline at Week 20 Number Analyzed 119 participants 232 participants 118 participants
-0.1  (0.83) -1.2  (1.39) -1.2  (1.31)
How satisfied with your eyelashes: Change From Baseline at Week 24 Number Analyzed 118 participants 228 participants 120 participants
-0.1  (0.73) -1.3  (1.41) -1.3  (1.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied Thickness Hair Coverage: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.2 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied Thickness Hair Coverage: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.4 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied Thickness Hair Coverage: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.3 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied Thickness Hair Coverage: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-1.6 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied Thickness Hair Coverage: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.5 to -1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied Thickness Hair Coverage: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-1.9 to -1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied Thickness Hair Coverage: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-1.6 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied Thickness Hair Coverage: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-1.8 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied evenness hair coverage: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.1 to -0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied evenness hair coverage: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.3 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied evenness hair coverage: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.2 to -0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied evenness hair coverage: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.4 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied evenness hair coverage: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.3 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied evenness hair coverage: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-1.6 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Satisfied evenness hair coverage: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-1.5 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Satisfied evenness hair coverage: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-1.8 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyebrows: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.3 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyebrows: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.4 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyebrows: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.3 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyebrows: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-1.6 to -1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyebrows: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.5 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyebrows: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-1.7 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyebrows: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.5 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyebrows: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-1.8 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyelashes: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.1 to -0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyelashes: Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.2 to -0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyelashes: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.2 to -0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyelashes: Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.3 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyelashes: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.3 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyelashes: Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.5 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments How satisfied with your eyelashes: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.4 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments How satisfied with your eyelashes: Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-1.6 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Hide Description HADS is questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Time Frame Baseline and Week 24
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Hide Analysis Population Description
Efficacy population= included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the= number of participants with data available for analysis of this outcome measure. Number of participants analyzed= indicates the number of participants with data available for analysis at the specified timepoint.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 118 228 120
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Anxiety: Baseline 6.2  (3.99) 6.4  (4.21) 6.2  (3.79)
Anxiety: Change From Baseline at Week 24 -0.6  (2.74) -1.1  (3.00) -0.8  (2.85)
Depression: Baseline 4.7  (3.96) 4.2  (3.66) 4.3  (3.56)
Depression: Change From Baseline at Week 24 -0.6  (2.97) -1.2  (3.16) -1.5  (2.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Anxiety
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1206
Comments P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.1 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Anxiety
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5367
Comments P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments Depression
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.2 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments Depression
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.4 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.33
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24
Hide Description SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame Week 24
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Hide Analysis Population Description
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description:
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Overall Number of Participants Analyzed 127 249 127
Measure Type: Number
Unit of Measure: Percentage of participants
0 24.9 26.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 8 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.19 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.027
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CTP-543 12 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.18 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.039
Estimation Comments [Not Specified]
Time Frame All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
Adverse Event Reporting Description All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
 
Arm/Group Title Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Hide Arm/Group Description Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
All-Cause Mortality
Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/130 (0.00%)   0/258 (0.00%)   0/129 (0.00%) 
Hide Serious Adverse Events
Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/130 (0.00%)   3/256 (1.17%)   2/129 (1.55%) 
Infections and infestations       
Appendicitis † 1  0/130 (0.00%)  1/256 (0.39%)  0/129 (0.00%) 
Pneumonia influenzal † 1  0/130 (0.00%)  1/256 (0.39%)  0/129 (0.00%) 
Injury, poisoning and procedural complications       
Radius fracture † 1  0/130 (0.00%)  0/256 (0.00%)  1/129 (0.78%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis † 1  0/130 (0.00%)  0/256 (0.00%)  1/129 (0.78%) 
Nervous system disorders       
Migraine with aura † 1  0/130 (0.00%)  1/256 (0.39%)  0/129 (0.00%) 
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo CTP-543 8 mg BID CTP-543 12 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   60/130 (46.15%)   137/256 (53.52%)   67/129 (51.94%) 
Infections and infestations       
COVID-19 † 1  22/130 (16.92%)  60/256 (23.44%)  24/129 (18.60%) 
Asymptomatic COVID-19 † 1  22/130 (16.92%)  33/256 (12.89%)  21/129 (16.28%) 
Nasopharyngitis † 1  16/130 (12.31%)  33/256 (12.89%)  16/129 (12.40%) 
Investigations       
Blood creatine phosphokinase increased † 1  4/130 (3.08%)  13/256 (5.08%)  15/129 (11.63%) 
Nervous system disorders       
Headache † 1  19/130 (14.62%)  32/256 (12.50%)  13/129 (10.08%) 
Skin and subcutaneous tissue disorders       
Acne † 1  3/130 (2.31%)  23/256 (8.98%)  13/129 (10.08%) 
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Colleen E. Hamilton
Organization: Concert Pharmaceuticals, Inc.
Phone: 781-860-0045
EMail: AAclinicaltrial_inquiries@concertpharma.com
Layout table for additonal information
Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04797650    
Other Study ID Numbers: CP543.3002
2021-000387-30 ( EudraCT Number )
First Submitted: March 10, 2021
First Posted: March 15, 2021
Results First Submitted: June 5, 2023
Results First Posted: July 3, 2023
Last Update Posted: July 3, 2023