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PF-06651600 for the Treatment...

PF-06651600 for the Treatment of Alopecia Areata

Last Updated: 2022-02-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

718 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2021-06-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence A

Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks

Group Type EXPERIMENTAL

PF-06651600 Induction Dose

Intervention Type DRUG

Oral tablets taken once daily (QD)

PF-06651600 Maintenance Dose #1

Intervention Type DRUG

Oral tablets taken QD

Sequence B

Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks

Group Type EXPERIMENTAL

PF-06651600 Induction Dose

Intervention Type DRUG

Oral tablets taken once daily (QD)

PF-06651600 Maintenance Dose #2

Intervention Type DRUG

Oral tablets taken QD

Sequence C

Maintenance dose #1 given QD for 48 weeks

Group Type EXPERIMENTAL

PF-06651600 Maintenance Dose #1

Intervention Type DRUG

Oral tablets taken QD

Sequence D

Maintenance dose #2 given QD for 48 weeks

Group Type EXPERIMENTAL

PF-06651600 Maintenance Dose #2

Intervention Type DRUG

Oral tablets taken QD

Sequence E

Maintenance dose #3 given QD for 48 weeks

Group Type EXPERIMENTAL

PF-06651600 Maintenance Dose #3

Intervention Type DRUG

Oral tablets taken QD

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

Group Type EXPERIMENTAL

PF-06651600 Induction Dose

Intervention Type DRUG

Oral tablets taken once daily (QD)

PF-06651600 Maintenance Dose #1

Intervention Type DRUG

Oral tablets taken QD

Placebo

Intervention Type DRUG

Oral tablets taken QD

Sequence G

Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks

Group Type EXPERIMENTAL

PF-06651600 Maintenance Dose #1

Intervention Type DRUG

Oral tablets taken QD

Placebo

Intervention Type DRUG

Oral tablets taken QD

Interventions

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PF-06651600 Induction Dose

Oral tablets taken once daily (QD)

Intervention Type DRUG

PF-06651600 Maintenance Dose #1

Oral tablets taken QD

Intervention Type DRUG

PF-06651600 Maintenance Dose #2

Oral tablets taken QD

Intervention Type DRUG

PF-06651600 Maintenance Dose #3

Oral tablets taken QD

Intervention Type DRUG

Placebo

Oral tablets taken QD

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The University of Alabama at Birmingham Hospital Outreach Lab

Birmingham, Alabama, United States

Site Status

The University of Alabama at Birmingham, Department of Dermatology

Birmingham, Alabama, United States

Site Status

The University of Alabama at Birmingham, Department of Dermatology

Birmingham, Alabama, United States

Site Status

Mosaic Dermatology

Beverly Hills, California, United States

Site Status

University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center

Irvine, California, United States

Site Status

Dermatology Specialists, Inc.

Murrieta, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Kaiser Permanente Clinical Trials Unit

San Francisco, California, United States

Site Status

Southern California Dermatology, Inc.

Santa Ana, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

University of Colorado Hospital Clinical and Translational Research Center

Aurora, Colorado, United States

Site Status

University of Colorado Hospital Outpatient Pavillion

Aurora, Colorado, United States

Site Status

Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Church Street Research Unit

New Haven, Connecticut, United States

Site Status

Medstar Georgetown University Hospital Center-Department of Otolaryngology

Washington D.C., District of Columbia, United States

Site Status

Medstar Washington Hospital Center-Claude Nogay Research Pharmacy

Washington D.C., District of Columbia, United States

Site Status

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Medstar Georgetown University Hospital Center-Department of Pediatrics

Washington D.C., District of Columbia, United States

Site Status

Siperstein Dermatology Group

Boynton Beach, Florida, United States

Site Status

Park Avenue Dermatology

Orange Park, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status