Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) (THRIVE-AA1)
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: NCT04518995 |
Recruitment Status :
Completed
First Posted : August 19, 2020
Results First Posted : May 3, 2023
Last Update Posted : May 3, 2023
|
Sponsor:
Concert Pharmaceuticals
Information provided by (Responsible Party):
Concert Pharmaceuticals
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 | 706 |
Participant Flow
Recruitment Details | Participants were enrolled at study centers in Canada, France, Poland, Spain and the United States from 23 November 2020 to 19 April 2022. |
Pre-assignment Details | 946 participants were screened, out of which 706 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 |
---|---|---|---|
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 | 140 | 351 | 215 |
Efficacy Population [1] | 140 | 351 | 215 |
Safety Population [2] | 140 | 350 | 215 |
Completed | 129 | 318 | 199 |
Not Completed | 11 | 33 | 16 |
Reason Not Completed | |||
Treatment Emergent or Worsening Adverse Event | 2 | 8 | 4 |
Lack of Efficacy | 2 | 1 | 0 |
Non-compliance With Study Drug | 0 | 3 | 2 |
Pregnancy | 0 | 0 | 1 |
Protocol Violation | 2 | 0 | 1 |
Reason not Specified | 4 | 11 | 2 |
Lost to Follow-up | 1 | 10 | 6 |
[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.
|
Baseline Characteristics
Arm/Group Title | Placebo | CTP-543 8 mg BID | CTP-543 12 mg BID | Total | |
---|---|---|---|---|---|
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 | 140 | 351 | 215 | 706 | |
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 | 140 participants | 351 participants | 215 participants | 706 participants | |
38.7 (13.81) | 38.9 (13.32) | 38.2 (12.80) | 38.6 (13.25) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 140 participants | 351 participants | 215 participants | 706 participants | |
Female |
89 63.6%
|
217 61.8%
|
131 60.9%
|
437 61.9%
|
|
Male |
51 36.4%
|
134 38.2%
|
84 39.1%
|
269 38.1%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 140 participants | 351 participants | 215 participants | 706 participants | |
Hispanic or Latino |
11 7.9%
|
30 8.5%
|
13 6.0%
|
54 7.6%
|
|
Not Hispanic or Latino |
119 85.0%
|
292 83.2%
|
188 87.4%
|
599 84.8%
|
|
Unknown or Not Reported |
10 7.1%
|
29 8.3%
|
14 6.5%
|
53 7.5%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Race | Number Analyzed | 140 participants | 351 participants | 215 participants | 706 participants |
American Indian or Alaska Native |
0 0.0%
|
2 0.6%
|
1 0.5%
|
3 0.4%
|
|
Asian |
10 7.1%
|
22 6.3%
|
21 9.8%
|
53 7.5%
|
|
Black or African American |
16 11.4%
|
40 11.4%
|
27 12.6%
|
83 11.8%
|
|
Native Hawaiian or other Pacific Islander |
1 0.7%
|
3 0.9%
|
1 0.5%
|
5 0.7%
|
|
White |
98 70.0%
|
241 68.7%
|
145 67.4%
|
484 68.6%
|
|
Other |
5 3.6%
|
17 4.8%
|
6 2.8%
|
28 4.0%
|
|
Not reported |
10 7.1%
|
26 7.4%
|
14 6.5%
|
50 7.1%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Colleen E. Hamilton |
Organization: | Concert Pharmaceuticals, Inc. |
Phone: | 781-860-0045 |
EMail: | AAclinicaltrial_inquiries@concertpharma.com |
Responsible Party: | Concert Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04518995 |
Other Study ID Numbers: |
CP543.3001 2020-002704-40 ( EudraCT Number ) |
First Submitted: | August 16, 2020 |
First Posted: | August 19, 2020 |
Results First Submitted: | April 7, 2023 |
Results First Posted: | May 3, 2023 |
Last Update Posted: | May 3, 2023 |