Phase 2
N=142
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT02974868 ↗Enrolled (actual)
142
Serious AEs
1.4%
Results posted
May 2020
Primary outcome: Primary: Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 — 32.54; 50.59; 1.41 units on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-06651600 (Drug); PF-06700841 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 |
32.54; 50.59; 1.41 | <.0001 sig |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period |
8; 12; 4; 10; 4; 3 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period |
4; 9; 2; 3 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities During SBE Period |
13; 11; 4; 11; 6; 9 | — |
| PRIMARY Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period |
5; 11; 1; 6; 0; 0 | — |
| SECONDARY Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants |
27.59; 48.42; 1.81 | 0.0094 sig |
| SECONDARY Percentage of Participants Achieving SALT 30 at Week 24 |
50.0; 63.8; 2.1 | <.0001 sig |
| SECONDARY Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) |
-0.74; -0.93; 1.18; 2.93; 7.70; 0.85 | — |
| SECONDARY Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) |
-0.76; -1.13; 1.26; 3.99; 9.70; 0.53 | — |
| SECONDARY Percentage of Participants Achieving SALT 30 Across Time (Treatment Period) |
-2.1; -2.1; 2.1; 6.2; 12.8; 2.1 | — |
| SECONDARY Percentage of Participants Achieving SALT 50 Across Time (Treatment Period) |
0.0; 0.0; 0; 0.0; 10.6; 0 | — |
| SECONDARY Percentage of Participants Achieving SALT 75 Across Time (Treatment Period) |
0.0; 0.0; 0; 0.0; 0.0; 0 | — |
| SECONDARY Percentage of Participants Achieving SALT 90 Across Time (Treatment Period) |
0.0; 0.0; 0; 0.0; 0.0; 0 | — |
| SECONDARY Percentage of Participants Achieving SALT 100 Across Time (Treatment Period) |
0.0; 0.0; 0; 0.0; 0.0; 0 | — |
| SECONDARY Number of Participants With the IGA Score Change (Treatment Period) |
48; 47; 47; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period |
32; 36; 35; 13; 20; 14 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities During Treatment Period |
35; 36; 32; 12; 29; 5 | — |
| SECONDARY Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period) |
10.1; 11.0; 16.1; 24.1; 21.1; NA | — |
| SECONDARY Change From Baseline in SALT Across Time (SBE Period) |
1.76; 0.09; 2.99; -0.31; 25.04; 19.83 | — |
| SECONDARY Percentage of Participants Achieving SALT 30 Across Time (SBE Period) |
4.1; -2.1; 3.8; -2.1; 47.9; 31.2 | — |
| SECONDARY Percentage of Participants Achieving SALT 50 Across Time (SBE Period) |
0.0; 0.0; 0.0; 0.0; 14.3; 20.0 | — |
| SECONDARY Percentage of Participants Achieving SALT 75 Across Time (SBE Period) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Achieving SALT 90 Across Time (SBE Period) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Achieving SALT 100 Across Time (SBE Period) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Summary
This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
- Must have moderate to severe alopecia areata:
Exclusion Criteria
- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
- Infected with hepatitis B or hepatitis C viruses.
- Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Have received any of the following treatment regiments specified in the timeframes outlined below:
Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.
Data sourced from ClinicalTrials.gov (NCT02974868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.