PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)
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ClinicalTrials.gov Identifier: NCT03732807 |
Recruitment Status :
Completed
First Posted : November 7, 2018
Results First Posted : February 24, 2022
Last Update Posted : February 24, 2022
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Alopecia Areata |
Interventions |
Drug: PF-06651600 Induction Dose Drug: PF-06651600 Maintenance Dose #1 Drug: PF-06651600 Maintenance Dose #2 Drug: PF-06651600 Maintenance Dose #3 Drug: Placebo |
Enrollment | 718 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Total 1097 participants signed the informed consent form. Out of which 379 participants were screen failures, 718 actually enrolled into the study and were assigned to study treatments. |
Arm/Group Title | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Ritlecitinib (PF-06651600) 50 mg | Ritlecitinib (PF-06651600) 30 mg | Ritlecitinib (PF-06651600) 10 mg | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Placebo, Ritlecitinib (PF-06651600) 50 mg |
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Arm/Group Description | Participants aged 12 years or above with moderate to severe alopecia areata (AA) with greater than or equal to (>=) 50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug . | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
Period Title: Treatment Period (up to Week 24) | |||||||
Started | 132 | 130 | 130 | 132 | 63 | 65 | 66 |
Completed | 122 | 124 | 121 | 117 | 58 | 63 | 61 |
Not Completed | 10 | 6 | 9 | 15 | 5 | 2 | 5 |
Reason Not Completed | |||||||
Adverse Event | 3 | 0 | 2 | 4 | 2 | 0 | 1 |
Lost to Follow-up | 1 | 0 | 1 | 2 | 1 | 0 | 0 |
Physician Decision | 0 | 1 | 2 | 5 | 0 | 0 | 1 |
Pregnancy | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
Protocol Violation | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 4 | 4 | 4 | 4 | 1 | 1 | 2 |
Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Period Title: Treatment Extension (Week 25 up to 48) | |||||||
Started | 113 [1] | 111 [1] | 108 [1] | 106 [1] | 49 [1] | 59 [1] | 57 [1] |
Completed | 107 | 100 | 103 | 97 | 44 | 56 | 53 |
Not Completed | 6 | 11 | 5 | 9 | 5 | 3 | 4 |
Reason Not Completed | |||||||
Adverse Event | 0 | 2 | 2 | 1 | 0 | 0 | 2 |
Lack of Efficacy | 2 | 1 | 0 | 3 | 3 | 0 | 1 |
Lost to Follow-up | 0 | 0 | 2 | 1 | 1 | 2 | 0 |
Non-Compliant with study drug | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Physician Decision | 0 | 1 | 0 | 1 | 1 | 0 | 0 |
Withdrawal by Subject | 3 | 2 | 1 | 1 | 0 | 1 | 1 |
Other | 1 | 4 | 0 | 2 | 0 | 0 | 0 |
[1]
Participants continued dosing according to their assigned sequence in the preceding period.
|
Baseline Characteristics
Arm/Group Title | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Ritlecitinib (PF-06651600) 50 mg | Ritlecitinib (PF-06651600) 30 mg | Ritlecitinib (PF-06651600) 10 mg | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Placebo, Ritlecitinib (PF-06651600) 50 mg | Total | |
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Arm/Group Description | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug . | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | Total of all reporting groups | |
Overall Number of Baseline Participants | 132 | 130 | 130 | 132 | 63 | 65 | 66 | 718 | |
Baseline Analysis Population Description |
Full analysis set (FAS) included all participants who were randomized, regardless of whether they received study medication.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||||||
Number Analyzed | 132 participants | 130 participants | 130 participants | 132 participants | 63 participants | 65 participants | 66 participants | 718 participants | |
34.5 (14.98) | 33.7 (13.75) | 32.4 (13.36) | 33.7 (14.83) | 34.3 (13.88) | 33.0 (14.01) | 35.0 (15.89) | 33.8 (14.33) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 132 participants | 130 participants | 130 participants | 132 participants | 63 participants | 65 participants | 66 participants | 718 participants | |
Female |
81 61.4%
|
85 65.4%
|
71 54.6%
|
80 60.6%
|
43 68.3%
|
46 70.8%
|
40 60.6%
|
446 62.1%
|
|
Male |
51 38.6%
|
45 34.6%
|
59 45.4%
|
52 39.4%
|
20 31.7%
|
19 29.2%
|
26 39.4%
|
272 37.9%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 132 participants | 130 participants | 130 participants | 132 participants | 63 participants | 65 participants | 66 participants | 718 participants | |
Hispanic or Latino |
18 13.6%
|
16 12.3%
|
11 8.5%
|
23 17.4%
|
8 12.7%
|
7 10.8%
|
4 6.1%
|
87 12.1%
|
|
Not Hispanic or Latino |
113 85.6%
|
114 87.7%
|
116 89.2%
|
109 82.6%
|
55 87.3%
|
58 89.2%
|
61 92.4%
|
626 87.2%
|
|
Unknown or Not Reported |
1 0.8%
|
0 0.0%
|
3 2.3%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 1.5%
|
5 0.7%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 132 participants | 130 participants | 130 participants | 132 participants | 63 participants | 65 participants | 66 participants | 718 participants | |
American Indian or Alaska Native |
0 0.0%
|
1 0.8%
|
0 0.0%
|
2 1.5%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 0.4%
|
|
Asian |
33 25.0%
|
28 21.5%
|
43 33.1%
|
34 25.8%
|
17 27.0%
|
14 21.5%
|
17 25.8%
|
186 25.9%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 1.6%
|
0 0.0%
|
0 0.0%
|
1 0.1%
|
|
Black or African American |
6 4.5%
|
7 5.4%
|
5 3.8%
|
3 2.3%
|
2 3.2%
|
2 3.1%
|
2 3.0%
|
27 3.8%
|
|
White |
92 69.7%
|
90 69.2%
|
79 60.8%
|
91 68.9%
|
42 66.7%
|
47 72.3%
|
47 71.2%
|
488 68.0%
|
|
More than one race |
0 0.0%
|
3 2.3%
|
1 0.8%
|
2 1.5%
|
0 0.0%
|
2 3.1%
|
0 0.0%
|
8 1.1%
|
|
Unknown or Not Reported |
1 0.8%
|
1 0.8%
|
2 1.5%
|
0 0.0%
|
1 1.6%
|
0 0.0%
|
0 0.0%
|
5 0.7%
|
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT03732807 |
Other Study ID Numbers: |
B7981015 2018-001714-14 ( EudraCT Number ) ALLEGRO 2B/3 ( Other Identifier: Alias Study Number ) |
First Submitted: | November 5, 2018 |
First Posted: | November 7, 2018 |
Results First Submitted: | December 16, 2021 |
Results First Posted: | February 24, 2022 |
Last Update Posted: | February 24, 2022 |