PF-06651600 for the Treatment of Alopecia Areata
Purpose
This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
Condition
- Alopecia Areata
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Clinical diagnosis of alopecia areata with no other cause of hair loss - ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months - Current episode of hair loss ≤10 years
Exclusion Criteria
- Other types of alopecia or other diseases that can cause hair loss - Other scalp diseases that could interfere with assessment of hair loss/regrowth - Subjects with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator - Any previous use of any Janus kinase (JAK) inhibitor
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Sequence A |
Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks |
|
Experimental Sequence B |
Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks |
|
Experimental Sequence C |
Maintenance dose #1 given QD for 48 weeks |
|
Experimental Sequence D |
Maintenance dose #2 given QD for 48 weeks |
|
Experimental Sequence E |
Maintenance dose #3 given QD for 48 weeks |
|
Experimental Sequence F |
Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks |
|
Experimental Sequence G |
Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer