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

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ClinicalTrials.gov Identifier: NCT02974868
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: PF-06651600 Drug: PF-06700841 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model Description: The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD
Actual Study Start Date : December 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
PF-06651600
Drug: PF-06651600
200 mg QD during induction and 50 mg QD during Maintenance

Experimental: Cohort 2
PF-06700841
Drug: PF-06700841
60 mg QD during induction and 30 mg QD during maintenance

Placebo Comparator: Cohort placebo
placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline of Severity of Alopecia Tool (SALT) score at Week 24. [ Time Frame: baseline, 24 weeks ]
    assessment of the overall severity of alopecia areata

  2. Incidence of treatment emergent adverse events (AEs) during the Extension Period [ Time Frame: Baseline of extension period (Week 28) up to 12 months ]
  3. Incidence of specific clinical laboratory abnormalities including but not limited to anemia, neutropenia, thrombocytopenia, lymphopenia, changes in lipid profile, and liver function tests (LFTs) during the Extension Period [ Time Frame: Baseline of extension period (Week 28) up to 12 months ]
  4. Indicence of TEAE during the cross over extension perod [ Time Frame: baseline of cross over extension, 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving a 30% improvement in SALT (SALT 30) at Week 24 [ Time Frame: 24 weeks ]
    overall assessment of severity of AA

  2. Change from baseline in Investigator Global Assessment (IGA) [ Time Frame: baseline, 32 weeks ]
    overall severity of AA

  3. Change from baseline in SALT [ Time Frame: baseline, 32 weeks ]
    overall severity of AA

  4. Proportion of subjects achieving a 30% improvement in SALT (SALT 30) [ Time Frame: 32 weeks ]
    severity of AA

  5. Proportion of subjects achieving a 50% improvement in SALT (SALT 50) [ Time Frame: 32 weeks ]
    severity of AA

  6. Percentage change in SALT from baseline to Week 24 [ Time Frame: baseline, 24 weeks ]
    severity of AA

  7. Proportion of subjects achieving a 75% improvement in SALT (SALT 75) [ Time Frame: 32 weeks ]
    severity of AA

  8. Proportion of subjects achieving a 100% improvement in SALT (SALT 100) [ Time Frame: 32 weeks ]
    severity of AA

  9. Incidence of treatment emergent adverse events (AEs) up to Week 24 [ Time Frame: Day 1 to Week 24 ]
  10. Incidence of specific clinical laboratory abnormalities including but not limited to anemia, neutropenia, thrombocytopenia, lymphopenia, changes in lipid profile, and liver function tests (LFTs) up to Week 24 [ Time Frame: Day 1 to week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974868


  Hide Study Locations
Locations
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United States, Alabama
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, United States, 35233
United States, California
Southern California Dermatology, Inc.
Santa Ana, California, United States, 92701
Clinical Science Institute
Santa Monica, California, United States, 90404
Office of F. Monte Purcelli
Santa Monica, California, United States, 90404
Tower Saint John's Imaging
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Hospital Clinical and Translational Research Center, Inpatient Unit
Aurora, Colorado, United States, 80045
University of Colorado Hospital Clinical and Translational Research Center, Outpatient Clinic
Aurora, Colorado, United States, 80045
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Investigational Drug Services
New Haven, Connecticut, United States, 06511
Church Street Research Unit
New Haven, Connecticut, United States, 06519
Yale Hearing and Balance Center
New Haven, Connecticut, United States, 06519
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
United States, Florida
Park Avenue Dermatology Administrative Annex
Orange Park, Florida, United States, 32073
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
Edward B. Kampsen, MD
Tampa, Florida, United States, 33609
Olympian Clinical Research
Tampa, Florida, United States, 33609
Rose Radiology
Tampa, Florida, United States, 33609
Forward Clinical Trials, Inc
Tampa, Florida, United States, 33624
United States, Georgia
MedaPhase Inc.
Newnan, Georgia, United States, 30263
United States, Illinois
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, United States, 60077
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, United States, 02114
United States, New York
Weill Cornell Medicine
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Mount Sinai Department of Otolaryngology
New York, New York, United States, 10029
Rockefeller University Hospital
New York, New York, United States, 10065
Investigational Drug Service
Rochester, New York, United States, 14642
University of Rochester Audiology
Rochester, New York, United States, 14642
University of Rochester Medical Center
Rochester, New York, United States, 14642
University of Rochester Radiology
Rochester, New York, United States, 14642
United States, Oklahoma
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States, 74136
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Utah
University of Utah MidValley Dermatology
Murray, Utah, United States, 84107
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Australia, New South Wales
Hearing Life
Hurstville, New South Wales, Australia, 2220
Dr. Glen and Partners Medical Imaging
Kogarah, New South Wales, Australia, 2217
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia, 2217
St. George Hearing and Balance Clinic
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Australia, V IC
Bridge Road Imag ing
Richmond, V IC, Australia, 3 I21
Australia, Victoria
Skin & Cancer Foundation Inc.
Carlton, Victoria, Australia, 3053
Sinclair Dermatology
East Melbourne, Victoria, Australia, 3002
Richmond Audiology
Richmond, Victoria, Australia, 3121
Canada, Manitoba
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Ontario
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
Research by ICLS
Oakville, Ontario, Canada, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
York Dermatology Center
Richmond Hill, Ontario, Canada, L4C 9M7
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02974868     History of Changes
Other Study ID Numbers: B7931005
2016-004048-13 ( EudraCT Number )
ALLEGRO ( Other Identifier: Alias Study Number )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Phase 2
randomized
double-blind
placebo
alopecia areata
safety
efficacy
JAK
janus kinase
moderate
severe
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical