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

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

ArmDescriptionAssigned Intervention
Experimental
Sequence A
Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
  • Drug: PF-06651600 Induction Dose
    Oral tablets taken once daily (QD)
  • Drug: PF-06651600 Maintenance Dose #1
    Oral tablets taken QD
Experimental
Sequence B
Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
  • Drug: PF-06651600 Induction Dose
    Oral tablets taken once daily (QD)
  • Drug: PF-06651600 Maintenance Dose #2
    Oral tablets taken QD
Experimental
Sequence C
Maintenance dose #1 given QD for 48 weeks
  • Drug: PF-06651600 Maintenance Dose #1
    Oral tablets taken QD
Experimental
Sequence D
Maintenance dose #2 given QD for 48 weeks
  • Drug: PF-06651600 Maintenance Dose #2
    Oral tablets taken QD
Experimental
Sequence E
Maintenance dose #3 given QD for 48 weeks
  • Drug: PF-06651600 Maintenance Dose #3
    Oral tablets taken QD
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
  • Drug: PF-06651600 Induction Dose
    Oral tablets taken once daily (QD)
  • Drug: PF-06651600 Maintenance Dose #1
    Oral tablets taken QD
  • Drug: Placebo
    Oral tablets taken QD
Experimental
Sequence G
Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
  • Drug: PF-06651600 Maintenance Dose #1
    Oral tablets taken QD
  • Drug: Placebo
    Oral tablets taken QD

More Details

Status
Completed
Sponsor
Pfizer

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.