Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

Completed · Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.

Key facts

Study ID

NCT02974868

Run by

Pfizer

People needed

142

Starts

2016-12-15

Expected to finish

2019-05-15

Last updated by the study team

2020-05-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
• Must have moderate to severe alopecia areata:

You may not qualify if…

• History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
• Infected with hepatitis B or hepatitis C viruses.
• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
• Have received any of the following treatment regiments specified in the timeframes outlined below:
• Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
• Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
• Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.

Where it is running

• University of Alabama at Birmingham, The Kirklin Clinic — Birmingham, Alabama, United States
• Southern California Dermatology, Inc. — Santa Ana, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Office of F. Monte Purcelli — Santa Monica, California, United States
• Tower Saint John's Imaging — Santa Monica, California, United States
• University of Colorado Hospital Clinical and Translational Research Center, Inpatient Unit — Aurora, Colorado, United States
• University of Colorado Hospital Clinical and Translational Research Center, Outpatient Clinic — Aurora, Colorado, United States
• University of Colorado Hospital, Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Investigational Drug Services — New Haven, Connecticut, United States
• Church Street Research Unit — New Haven, Connecticut, United States
• Yale Hearing and Balance Center — New Haven, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Park Avenue Dermatology Administrative Annex — Orange Park, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Edward B. Kampsen, MD — Tampa, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Rose Radiology — Tampa, Florida, United States
• Forward Clinical Trials, Inc — Tampa, Florida, United States
• MedaPhase Inc. — Newnan, Georgia, United States
• NorthShore University HealthSystem Dermatology Clinical Trials Unit — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Alabama at Birmingham, Dermatology at the Whitaker Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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