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

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