Long-Term PF-06651600 for the Treatment of Alopecia Areata
NCT ID: NCT04006457
Last Updated: 2025-08-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1052 participants
INTERVENTIONAL
2019-07-18
2026-01-23
Brief Summary
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A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment sequence 1
Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months.
Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.
PF-06651600
50 mg oral tablets/capsules
Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Treatment sequence 2
Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months.
Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.
PF-06651600
50 mg oral tablets/capsules
Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Interventions
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PF-06651600
50 mg oral tablets/capsules
Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
* De novo participants \>=12 to \<18 years of age: \>=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
* De novo participants \>=18 years of age and participants from Study B7931005 or B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study: \>=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
* No evidence of terminal scalp hair regrowth within 6 months (de novo only)
* Current episode of terminal scalp hair loss \<=10 years (de novo only)
Exclusion Criteria
* Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
* History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
* History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
* Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1
\- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose \>12 weeks prior to the screening visit
12 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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The University of Alabama at Birmingham Hosptial Outreach Lab
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
The University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, United States
Mosaic Dermatology
Beverly Hills, California, United States
Univ of California, Irvine, Dermatology Clinical Research Center
Irvine, California, United States
Dermatology Specialists Inc.
Murrieta, California, United States
University of California, San Francisco
San Francisco, California, United States
Kaiser Permanente Clinical Trials Unit
San Francisco, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Hospital Clinical and Translational Research Center
Aurora, Colorado, United States
University of Colorado Hospital Outpatient Pavilion
Aurora, Colorado, United States
Yale School of Medicine, Yale Center for Clinical Investigations
New Haven, Connecticut, United States
Medstar Georgetown University Hospital - Department of Otolaryngology
Washington D.C., District of Columbia, United States
Medstar Georgetown University Hospital-Dept of Otolaryngology
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Medstar Georgetown University Hospital - Department of Pediatrics
Washington D.C., District of Columbia, United States
Siperstein Dermatology Group
Boynton Beach, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Velocity Clinical Research - Boise
Meridian, Idaho, United States
Northwestern Medical Group
Chicago, Illinois, United States
Northwestern Medicine Diagnostic Testing Center
Chicago, Illinois, United States
Northwestern Medicine
Chicago, Illinois, United States
Northwestern Memorial Hospital Investigational Drug Service Pharmacy
Chicago, Illinois, United States
Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)
Oakbrook Terrace, Illinois, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Medstar Georgetown University Hospital - Department of Dermatology
Chevy Chase, Maryland, United States
Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, United States
University of Minnesota Clinical Research Unit (CRU)
Minneapolis, Minnesota, United States
University of Minnesota Lillehei Clinical Research Unit (LCRU)
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
Minneapolis, Minnesota, United States
Skin Specialists, PC (Schlessinger MD)
Omaha, Nebraska, United States
Schweiger Dermatology, P.C.
Verona, New Jersey, United States
NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
New York, New York, United States
Pura Dermatology (in c/o TrialSpark, Inc)
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
UNC CTRC
Chapel Hill, North Carolina, United States
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
Tamjidi Skin Institute (in c/o TrialSpark, Inc)
Vienna, Virginia, United States
CINME Centro de Investigaciones Metabolicas
CABA, Buenos Aires, Argentina
Psoriahue Medicina Interdisciplinaria
CABA, , Argentina
Premier Specialists Pty Ltd
Kogarah, New South Wales, Australia
St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Skin Health Institute
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, Canada
Guenther Research Inc
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
The Centre for Clinical Trials
Oakville, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, Canada
Centro Medico Skin Med
Santiago, LAS Condes, Chile
Centro Internacional de Estudios Clinicos - CIEC
Santiago, Recoleta, Chile
Clinica Dermacross S.A.
Santiago, Vitacura, Chile
Medical Skin Center
Viña del Mar, , Chile
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Fundacion Centro de Investigacion Clinica CIC
Medellín, Antioquia, Colombia
Fundacion Hospitalaria San Vicente de Paul
Medellín, Antioquia, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
Bogota D.C., , Colombia
DERMAMEDICA s.r.o.
Náchod, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Sanatorium profesora Arenbergera
Prague, , Czechia
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Emovis GmbH
Berlin, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
University Hospital Frankfurt
Frankfurt am Main, , Germany
University Hospital Schleswig-Holstein
Lübeck, , Germany
University Hospital Muenster
Münster, , Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Sociedad de Metabolismo y Corazon S.C.
Veracruz, , Mexico
Hospital D Maria
Veracruz, , Mexico
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland
McBk S.C.
Grodzisk Mazowiecki, , Poland
Centermed Krakow Sp.z o.o.
Krakow, , Poland
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
Lodz, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
RCMed Oddzial Warszawa
Warsaw, , Poland
Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
Warsaw, , Poland
ETG Warszawa
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu
Wroclaw, , Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, , Poland
Centrum Medyczne OPOROW
Wroclaw, , Poland
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"
Chelyabinsk, , Russia
University Clinic of Kirov SMU
Kirov, , Russia
FSBEI HE Russian University of Medicine of the MoH of Russia
Moscow, , Russia
Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"
Moscow, , Russia
State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
Rostov-on-Don, , Russia
Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
Saint Petersburg, , Russia
Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
Saint Petersburg, , Russia
Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
Saint Petersburg, , Russia
State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital
Yaroslavl, , Russia
Pusan National University Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz: Servicio de Farmacia
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Chung-Shan Medical University Hospital
Taichung, R.o.c., Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
University Hospitals Sussex NHS Foundation Trust (UHSussex)
Brighton, , United Kingdom
NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital
London, , United Kingdom
Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital
London, , United Kingdom
Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital
London, , United Kingdom
Countries
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References
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King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair R, Asfour L, Ezzedine K, Paul C, Ohyama M, Edwards RA, Bonfanti G, Kerkmann U, Wajsbrot D, Ishowo-Adejumo R, Zwillich SH, Lejeune A. Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1163-1173. doi: 10.1111/jdv.20547. Epub 2025 Feb 17.
Tziotzios C, Sinclair R, Lesiak A, Mehlis S, Kinoshita-Ise M, Tsianakas A, Luo X, Law EH, Ishowo-Adejumo R, Wolk R, Sadrarhami M, Lejeune A. Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the ALLEGRO-LT phase 3, open-label study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1152-1162. doi: 10.1111/jdv.20526. Epub 2025 Jan 23.
Piliang M, Soung J, King B, Shapiro J, Rudnicka L, Farrant P, Magnolo N, Piraccini BM, Luo X, Wolk R, Woodworth D, Schaefer G, Lejeune A. Efficacy and safety of the oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor ritlecitinib over 24 months: integrated analysis of the ALLEGRO phase IIb/III and long-term phase III clinical studies in alopecia areata. Br J Dermatol. 2025 Jan 24;192(2):215-227. doi: 10.1093/bjd/ljae365.
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: Main study
Document Type: Statistical Analysis Plan: sub study SAP
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-509801-59-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
B7981032
Identifier Type: -
Identifier Source: org_study_id
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