PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
NCT ID: NCT04517864
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
71 participants
INTERVENTIONAL
2020-09-15
2024-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
TRIPLE
Study Groups
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Treatment Arm: PF-06651600
ritlecitinib 200 milligram (mg) once per day (QD) (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. At Month 9, participants assigned to this treatment arm will also receive 3 tablets of placebo for 4 weeks to maintain the blind with the other arm. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.
PF-06651600
50 mg tablet, dosed as 200 mg QD or 50 mg QD 50 mg capsule, dosed as 50 mg QD
Control Arm (Placebo) followed by active therapy extension
matching comparator: placebo QD (4 tablets x 4 weeks then 1 tablet x 8 months) then ritlecitinib 200 mg QD (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.
Placebo
tablet, dosed as 4 tablets QD or 1 tablet QD
Interventions
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PF-06651600
50 mg tablet, dosed as 200 mg QD or 50 mg QD 50 mg capsule, dosed as 50 mg QD
Placebo
tablet, dosed as 4 tablets QD or 1 tablet QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 25% hair loss due to alopecia areata
* Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs)
* Must have a normal neurological exam; can have a stable unilateral median neuropathy or ulnar neuropathy
* Signed informed consent
* Stable regimen for other medications before and during the study
Exclusion Criteria
* Occupational or recreational noise exposure
* History of peripheral neuropathy or first degree relative with a hereditary peripheral neuropathy
* HbA1c \> or = 7.5% at Screening
* Recurrent or disseminated Herpes Zoster
* Active or chronic infection; or infection requiring hospitalization or IV antimicrobials within 6 months
* Active or latent (insufficiently treated) Hepatitis
* Active or latent (insufficiently treated) TB
* Concomitant medications associated with peripheral neurologic or hearing loss
* Protocol specific laboratory abnormalities
18 Years
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Marvel Clinical Research 002, LLC
Huntington Beach, California, United States
University of California, Irvine
Irvine, California, United States
Skin Care Research, LLC
Boca Raton, Florida, United States
Skin Care Research, LLC
Hollywood, Florida, United States
Kendall Adkisson, MD - Intracoastal Dermatology
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Y&L Advance Health Care Inc., d/b/a Elite Clinical Research
Miami, Florida, United States
BRCR Medical Center Inc
Miramar, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, Florida, United States
Orlando Dermatology & Skin Cancer Surgery Center
Oviedo, Florida, United States
USF Health Morsani Center For Advanced Healthcare
Tampa, Florida, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, United States
NorthShore University HealthSystem Dermatology Clinic
Skokie, Illinois, United States
Washington University School of Medicine-Dermatology
St Louis, Missouri, United States
University of New Mexico Department of Dermatology
Albuquerque, New Mexico, United States
University of New Mexico Clinical & Translational Sciences Center
Albuquerque, New Mexico, United States
Stony Brook Dermatology
Stony Brook, New York, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Tekton Research, Inc.
Austin, Texas, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, United States
Summit Clinical Research, LLC
Franklin, Virginia, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, United States
Premier Specialists Pty Ltd
Kogarah, New South Wales, Australia
Eastern Health - Box Hill Hospital
Box Hill, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Lynderm Research Inc.
Markham, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Sima Recherche
Verdun, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny "DERMAL"
Bialystok, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
Krakow, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
RCMed Oddzial Warszawa
Warsaw, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Przychodnia przy ul. Lowieckiej
Wroclaw, , Poland
Centrum Medyczne Matusiak
Wroclaw, , Poland
Countries
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References
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King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2020-001509-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7981037
Identifier Type: -
Identifier Source: org_study_id
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