PF-06651600 for the Treatment of Alopecia Areata

ID#: NCT03732807

Age: 12 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2/Phase 3

Recruitment Status: Recruiting

Start Date: December 03, 2018

End Date: March 28, 2021

Contact Information:
Pfizer CT.gov Call Center
1-800-718-1021
Summary: 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.
Eligibility:

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
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