Long-Term PF-06651600 for the Treatment of Alopecia Areata

Last updated: April 21, 2025
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hair Loss

Alopecia

Treatment

PF-06651600

Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine

Clinical Study ID

NCT04006457
B7981032
2019-001084-71
2023-509801-59-00
ALLEGRO LT
  • Ages > 12
  • All Genders

Study Summary

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

  • 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-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

  • 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

Exclusion criteria for all participants:

  • 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

Study Design

Total Participants: 1052
Treatment Group(s): 3
Primary Treatment: PF-06651600
Phase: 3
Study Start date:
July 18, 2019
Estimated Completion Date:
January 23, 2026

Connect with a study center

  • CINME Centro de Investigaciones Metabolicas

    Caba, Buenos Aires C1027AAP
    Argentina

    Site Not Available

  • Psoriahue Medicina Interdisciplinaria

    Caba, C1425DKG
    Argentina

    Site Not Available

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • St George Dermatology & Skin Cancer Centre

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • The Skin Centre

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Skin Health Institute

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Sinclair Dermatology

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Royal Melbourne Hospital, Melbourne Health

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Eastern Canada Cutaneous Research Associates Ltd.

    Halifax, Nova Scotia B3H 1Z2
    Canada

    Site Not Available

  • Guenther Research Inc

    London, Ontario N6A 3H7
    Canada

    Site Not Available

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • The Centre for Clinical Trials

    Oakville, Ontario L6J 7W5
    Canada

    Site Not Available

  • SKiN Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • Medicor Research Inc

    Sudbury, Ontario P3C 1X3
    Canada

    Site Not Available

  • Sudbury Skin Clinique

    Sudbury, Ontario P3C 1X8
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • Innovaderm Research Inc.

    Montreal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

    Quebec, G1V 4X7
    Canada

    Site Not Available

  • Centro Medico Skin Med

    Santiago, LAS Condes 7580206
    Chile

    Site Not Available

  • Centro Internacional de Estudios Clinicos - CIEC

    Santiago, Recoleta 8420383
    Chile

    Site Not Available

  • Clinica Dermacross S.A.

    Santiago, Vitacura 7640881
    Chile

    Site Not Available

  • Medical Skin Center

    Vina del Mar, 2542577
    Chile

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong 518053
    China

    Site Not Available

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Fundacion Centro de Investigacion Clinica CIC

    Medellin, Antioquia 050001
    Colombia

    Site Not Available

  • Fundacion Hospitalaria San Vicente de Paul

    Medellin, Antioquia 050010
    Colombia

    Site Not Available

  • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S

    Bogota D.C., 110221
    Colombia

    Site Not Available

  • DERMAMEDICA s.r.o.

    Nachod, 547 01
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Sanatorium profesora Arenbergera

    Praha 1, 110 00
    Czechia

    Site Not Available

  • Clintrial s.r.o.

    Praha 10, 100 00
    Czechia

    Site Not Available

  • Nemocnice Na Bulovce

    Praha 8, 180 81
    Czechia

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Benthelm, Lower Saxony 48455
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Emovis GmbH

    Berlin, 10629
    Germany

    Site Not Available

  • Universitaetsklinikum Erlangen

    Erlangen, 91054
    Germany

    Site Not Available

  • University Hospital Frankfurt

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • University Hospital Schleswig-Holstein

    Luebeck, 23538
    Germany

    Site Not Available

  • University Hospital Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1085
    Hungary

    Site Not Available

  • Debreceni Egyetem

    Debrecen, 4032
    Hungary

    Site Not Available

  • Bugat Pal Korhaz, Borgyogyaszat

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Site Not Available

  • Osaka City University Hospital

    Osaka-City, Osaka 545-8586
    Japan

    Site Not Available

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • Juntendo Tokyo Koto Geriatric Medical Center

    Koto-ku, Tokyo 136-0075
    Japan

    Site Not Available

  • Kyorin University Hospital

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • Kyorin University Hospital

    Mitaka-shi, Tokyo 181-8611
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo LEON 64460
    Mexico

    Site Not Available

  • Hospital D Maria

    Veracruz, 91910
    Mexico

    Site Not Available

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91900
    Mexico

    Site Not Available

  • Twoja Przychodnia SCM

    Szczecin, Zachodniopomorskie 71-500
    Poland

    Site Not Available

  • NZOZ Osteo-Medic s.c. A.Racewicz, J. Supronik

    Bialystok, 15-351
    Poland

    Site Not Available

  • McBk S.C.

    Grodzisk Mazowiecki, 05-825
    Poland

    Site Not Available

  • Centermed Krakow Sp.z o.o.

    Krakow, 31-530
    Poland

    Site Not Available

  • Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436
    Poland

    Site Not Available

  • DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.

    Osielsko, 86-031
    Poland

    Site Not Available

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • ETG Warszawa

    Warszawa, 02-793
    Poland

    Site Not Available

  • Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej

    Warszawa, 02-661
    Poland

    Site Not Available

  • RCMed Oddzial Warszawa

    Warszawa, 00-892
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warszawa, 02-962
    Poland

    Site Not Available

  • Centrum Medyczne OPOROW

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, 50-566
    Poland

    Site Not Available

  • EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu

    Wroclaw, 50-220
    Poland

    Site Not Available

  • State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"

    Chelyabinsk, 454092
    Russian Federation

    Site Not Available

  • University Clinic of Kirov SMU

    Kirov, 610035
    Russian Federation

    Site Not Available

  • Clinical Medical Center of Moscow State University of Medicine and Dentistry

    Moscow, 111398
    Russian Federation

    Site Not Available

  • FSBEI HE Russian University of Medicine of the MoH of Russia

    Moscow, 111398
    Russian Federation

    Site Not Available

  • Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"

    Moscow, 119991
    Russian Federation

    Site Not Available

  • State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"

    Rostov-on-Don, 344002
    Russian Federation

    Site Not Available

  • Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)

    Saint Petersburg, 191123
    Russian Federation

    Site Not Available

  • Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"

    Saint Petersburg, 191123
    Russian Federation

    Site Not Available

  • Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -

    Saint Petersburg, 194021
    Russian Federation

    Site Not Available

  • Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"

    Saint Petersburg,, 191123
    Russian Federation

    Site Not Available

  • State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario La Paz: Servicio de Farmacia

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Chung-Shan Medical University Hospital

    Taichung, R.o.c. 40201
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301
    Taiwan

    Site Not Available

  • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • University Hospitals Sussex NHS Foundation Trust (UHSussex)

    Brighton, BN2 1ES
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • The University of Alabama at Birmingham Hosptial Outreach Lab

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • The University of Alabama at Birmingham, Department of Dermatology

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Mosaic Dermatology

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Univ of California, Irvine, Dermatology Clinical Research Center

    Irvine, California 92697
    United States

    Site Not Available

  • Dermatology Specialists Inc.

    Murrieta, California 92562
    United States

    Site Not Available

  • Kaiser Permanente Clinical Trials Unit

    San Francisco, California 94118
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • Southern California Dermatology, Inc.

    Santa Ana, California 92701
    United States

    Site Not Available

  • Mosaic Dermatology

    Santa Monica, California 90403
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Hospital Clinical and Translational Research Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Hospital Outpatient Pavilion

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Investigational Drug Services

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale School of Medicine, Yale Center for Clinical Investigation

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Yale School of Medicine, Yale Center for Clinical Investigations

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Georgetown University Hospital - Department of Otolaryngology

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Medstar Georgetown University Hospital - Department of Pediatrics

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Medstar Georgetown University Hospital-Dept of Otolaryngology

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Medstar Washington Hospital Center-Claude Nogay Research Pharmacy

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Siperstein Dermatology Group

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Park Avenue Dermatology

    Orange Park, Florida 32073
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Advanced Clinical Research @Treasure Valley Dermatology & Skin Cancer Center

    Boise, Idaho 83713
    United States

    Site Not Available

  • Velocity Clinical Research - Boise

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Northwestern Medical Group

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Medicine Diagnostic Testing Center

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital Investigational Drug Service Pharmacy

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)

    Oakbrook Terrace, Illinois 60181
    United States

    Site Not Available

  • NorthShore University HealthSystem Dermatology Clinical Trials Unit

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Northshore University HealthSystem/Dermatology

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Medstar Georgetown University Hospital - Department of Dermatology

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Minnesota Clinical Research Unit (CRU)

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota Lillehei Clinical Research Unit (LCRU)

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Skin Specialists PC

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Skin Specialists, PC (Schlessinger MD)

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Schweiger Dermatology Group

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Schweiger Dermatology, P.C.

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • NYU School of Medicine, The Ronald O. Perelman Department of Dermatology

    New York, New York 10016
    United States

    Site Not Available

  • Pura Dermatology (in c/o TrialSpark, Inc)

    New York, New York 10018
    United States

    Site Not Available

  • UNC CTRC

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • UNC Dermatology Clinical Trials Unit

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • UNC Dermatology and Skin Cancer Center

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • UNC Hospitals, Investigational Drug Service

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97201
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas 77401
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Tamjidi Skin Institute (in c/o TrialSpark, Inc)

    Vienna, Virginia 22182
    United States

    Site Not Available

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