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

Description

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 85 weeks. This includes an up to 5 weeks screening period, a 24 week treatment period, a 4 week drug holiday, an up to 12 month extension period, and a 4 week follow up period. The study will enroll a total of approximately 132 subjects. The study will be conducted at approximately 30 to 40 sites.

Study Start Date

December, 15 2016

Estimated Completion Date

May 2019

Interventions

  • Drug: PF-06651600
  • Drug: Placebo
  • Drug: PF-06700841

Study ID

Pfizer -- B7931005

Status

Recruiting

Trial ID

NCT02974868

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

132

Sponsor

Pfizer

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (169)

Study Location Distance Name Phone Email
Massachusetts General Hospital Clinical Unit for Research Trials in Skin CURTIS - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Clinical Unit for Research Trials in Skin CURTIS - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Clinical Unit for Research Trials in Skin CURTIS - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Clinical Unit for Research Trials in Skin CURTIS - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Clinical Unit for Research Trials in Skin CURTIS - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Clinical Unit for Research Trials in Skin CURTIS - Boston, Massachusetts 2.8 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Investigational Drug Services - New Haven, Connecticut 118.9 miles None None None
Investigational Drug Services - New Haven, Connecticut 118.9 miles None None None
Investigational Drug Services - New Haven, Connecticut 118.9 miles None None None
Investigational Drug Services - New Haven, Connecticut 118.9 miles None None None
Yale School of Medicine - New Haven, Connecticut 119.2 miles None None None
Yale School of Medicine - New Haven, Connecticut 119.2 miles None None None
Yale School of Medicine - New Haven, Connecticut 119.2 miles None None None
Yale School of Medicine - New Haven, Connecticut 119.2 miles None None None
Yale School of Medicine - New Haven, Connecticut 119.2 miles None None None
Church Street Research Unit - New Haven, Connecticut 120.2 miles None None None
Yale New Haven Hospital Radiology - New Haven, Connecticut 120.2 miles None None None
Yale New Haven Hospital Radiology - New Haven, Connecticut 120.2 miles None None None
Yale New Haven Hospital Radiology - New Haven, Connecticut 120.2 miles None None None
Yale New Haven Hospital Radiology - New Haven, Connecticut 120.2 miles None None None
Yale New Haven Hospital Radiology - New Haven, Connecticut 120.2 miles None None None
Yale Hearing and Balance Center - New Haven, Connecticut 120.2 miles None None None
Church Street Research Unit - New Haven, Connecticut 120.2 miles None None None
Yale New Haven Hospital Radiology - New Haven, Connecticut 120.2 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Mount Sinai Department of Otolaryngology - New York, New York 183.2 miles None None None
Mount Sinai Department of Otolaryngology - New York, New York 183.2 miles None None None
Mount Sinai Department of Otolaryngology - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Mount Sinai Department of Otolaryngology - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Mount Sinai Department of Otolaryngology - New York, New York 183.2 miles None None None
Mount Sinai Department of Otolaryngology - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Rockefeller University Hospital - New York, New York 187.1 miles None None None
Rockefeller University Hospital - New York, New York 187.1 miles None None None
Rockefeller University Hospital - New York, New York 187.1 miles None None None
Rockefeller University Hospital - New York, New York 187.1 miles None None None
Rockefeller University Hospital - New York, New York 187.1 miles None None None
Rockefeller University Hospital - New York, New York 187.1 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
Investigational Drug Service - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
Investigational Drug Service - Rochester, New York 335.8 miles None None None
Investigational Drug Service - Rochester, New York 335.8 miles None None None
Investigational Drug Service - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
Investigational Drug Service - Rochester, New York 335.8 miles None None None
Investigational Drug Service - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Dermatology Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Dermatology Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Dermatology Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Dermatology Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Dermatology Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Dermatology Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
NorthShore University HealthSystem Dermatology Clinical Trials Unit - Skokie, Illinois 853.6 miles None None None
NorthShore University HealthSystem Dermatology Clinical Trials Unit - Skokie, Illinois 853.6 miles None None None
NorthShore University HealthSystem Dermatology Clinical Trials Unit - Skokie, Illinois 853.6 miles None None None
NorthShore University HealthSystem Dermatology Clinical Trials Unit - Skokie, Illinois 853.6 miles None None None
NorthShore University HealthSystem Dermatology Clinical Trials Unit - Skokie, Illinois 853.6 miles None None None
NorthShore University HealthSystem Dermatology Clinical Trials Unit - Skokie, Illinois 853.6 miles None None None
MedaPhase Inc - Newnan, Georgia 972.0 miles None None None
MedaPhase Inc - Newnan, Georgia 972.0 miles None None None
MedaPhase Inc - Newnan, Georgia 972.0 miles None None None
MedaPhase Inc - Newnan, Georgia 972.0 miles None None None
MedaPhase Inc - Newnan, Georgia 972.0 miles None None None
MedaPhase Inc - Newnan, Georgia 972.0 miles None None None
Park Avenue Dermatology Administrative Annex - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology Administrative Annex - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology Administrative Annex - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology Administrative Annex - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology Administrative Annex - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology Administrative Annex - Orange Park, Florida 1,031.2 miles None None None
Park Avenue Dermatology - Orange Park, Florida 1,031.2 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 1,051.7 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 1,051.7 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 1,051.7 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Rose Radiology - Tampa, Florida 1,187.2 miles None None None
Olympian Clinical Research - Tampa, Florida 1,187.2 miles None None None
Rose Radiology - Tampa, Florida 1,187.2 miles None None None
Rose Radiology - Tampa, Florida 1,187.2 miles None None None
Olympian Clinical Research - Tampa, Florida 1,187.2 miles None None None
Rose Radiology - Tampa, Florida 1,187.2 miles None None None
Olympian Clinical Research - Tampa, Florida 1,187.2 miles None None None
Rose Radiology - Tampa, Florida 1,187.2 miles None None None
Olympian Clinical Research - Tampa, Florida 1,187.2 miles None None None
Olympian Clinical Research - Tampa, Florida 1,187.2 miles None None None
Olympian Clinical Research - Tampa, Florida 1,187.2 miles None None None
Rose Radiology - Tampa, Florida 1,187.2 miles None None None
Health Concepts - Rapid City, South Dakota 1,618.4 miles None None None
Health Concepts - Rapid City, South Dakota 1,618.4 miles None None None
Health Concepts - Rapid City, South Dakota 1,618.4 miles None None None
Health Concepts - Rapid City, South Dakota 1,618.4 miles None None None
Health Concepts - Rapid City, South Dakota 1,618.4 miles None None None
Health Concepts - Rapid City, South Dakota 1,618.4 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Inpatient Unit - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Outpatient Clinic - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Outpatient Clinic - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Inpatient Unit - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Inpatient Unit - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Inpatient Unit - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Inpatient Unit - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Inpatient Unit - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Outpatient Clinic - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Outpatient Clinic - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Outpatient Clinic - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Clinical and Translational Research Center Outpatient Clinic - Aurora, Colorado 1,759.8 miles None None None
University of Utah Medical Center - Salt Lake City, Utah 2,094.1 miles None None None
University of Utah Medical Center - Salt Lake City, Utah 2,094.1 miles None None None
University of Utah Medical Center - Salt Lake City, Utah 2,094.1 miles None None None
University of Utah Medical Center - Salt Lake City, Utah 2,094.1 miles None None None
University of Utah Medical Center - Salt Lake City, Utah 2,094.1 miles None None None
University of Utah Medical Center - Salt Lake City, Utah 2,094.1 miles None None None
University of Utah MidValley Dermatology - Murray, Utah 2,098.3 miles None None None
University of Utah MidValley Dermatology - Murray, Utah 2,098.3 miles None None None
University of Utah MidValley Dermatology - Murray, Utah 2,098.3 miles None None None
University of Utah MidValley Dermatology - Murray, Utah 2,098.3 miles None None None
University of Utah MidValley Dermatology - Murray, Utah 2,098.3 miles None None None
University of Utah MidValley Dermatology - Murray, Utah 2,098.3 miles None None None
Southern California Dermatology Inc - Santa Ana, California 2,584.7 miles None None None
Southern California Dermatology Inc - Santa Ana, California 2,584.7 miles None None None
Southern California Dermatology Inc - Santa Ana, California 2,584.7 miles None None None
Southern California Dermatology Inc - Santa Ana, California 2,584.7 miles None None None
Southern California Dermatology Inc - Santa Ana, California 2,584.7 miles None None None
Southern California Dermatology Inc - Santa Ana, California 2,584.7 miles None None None
Clinical Science Institute - Santa Monica, California 2,607.9 miles None None None
Clinical Science Institute - Santa Monica, California 2,607.9 miles None None None
Clinical Science Institute - Santa Monica, California 2,607.9 miles None None None
Clinical Science Institute - Santa Monica, California 2,607.9 miles None None None

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