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Um estudo de 2 doses de ritlecitinibe em pessoas com 12 anos de idade ou mais com alopecia areata (ALLEGRO-100)

16 de outubro de 2026 atualizado por: Pfizer

Um estudo randomizado de fase 3, externo e sintético controlado por placebo, com dose-up para não respondedores para investigar a segurança e a eficácia do ritlecitinibe 50 mg e 100 mg uma vez ao dia em participantes adultos e adolescentes com 12 anos de idade e mais com alopecia areata

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.

Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.

This study is seeking participants who:

  • Are 12 years of age or older (Part 1)
  • Are 12 to less than 18 years (Part 2)
  • Have a diagnosis of alopecia areata
  • Have lost 50% or more of the hair on their scalp
  • Do not have any other conditions that causes hair loss
  • Are willing to stop all other treatments that they may be taking for alopecia areata

About 550 participants will take part in Part 1 of this study. About 80 participants will take part in Part 2 of this study.

In Part 1, participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.

The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.

In Part 2, all eligible participants will receive ritlecitinib 100 mg taken by mouth once daily. The data from this part of the study will be combined with the data from Part 1 of the study to help to see if the 100 mg dose of ritlecitinib is safe and effective in adolescent patients with alopecia areata.

People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:

  • alopecia areata assessment,
  • physical examinations,
  • hearing tests,
  • blood tests,
  • x-ray,
  • ECG (electrocardiogram),
  • photographs of the scalp and eyes (Part 1 only). Participants will also be asked to complete questionnaires about their alopecia areata.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

674

Estágio

  • Fase 3

Acesso expandido

Disponível fora do ensaio clínico. Consulte registro de acesso expandido.

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Canadá
      • Québec, Canadá, G1V 3V9
        • Ativo, não recrutando
        • Centre de Recherche Saint-Louis
      • Québec, Canadá, G1V 4X7
        • Ativo, não recrutando
        • Centre de Recherche Dermatologique du Quebec metropolitain
      • Québec, Canadá, G1W 4R4
        • Ativo, não recrutando
        • Centre de Recherche Saint-Louis inc.
    • Alberta
      • Calgary, Alberta, Canadá, T2J 7E1
        • Ativo, não recrutando
        • Dermatology Research Institute
      • Red Deer, Alberta, Canadá, T4P 1K4
        • Ativo, não recrutando
        • CaRe Clinic
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3M 3Z4
        • Ativo, não recrutando
        • Wiseman Dermatology Research Inc.
    • Ontario
      • Barrie, Ontario, Canadá, L4M 7G1
        • Ativo, não recrutando
        • SimcoDerm Medical and Surgical Dermatology Center
      • Guelph, Ontario, Canadá, N1L 0B7
        • Ativo, não recrutando
        • Guelph Dermatology Research
      • London, Ontario, Canadá, N6H 5L5
        • Ativo, não recrutando
        • DermEffects
      • Markham, Ontario, Canadá, L3P 1X3
        • Ativo, não recrutando
        • Lynderm Research Inc.
      • Newmarket, Ontario, Canadá, L3Y 5G8
        • Ativo, não recrutando
        • Ryan Clinical Research Inc.
      • Oakville, Ontario, Canadá, L6J 7W5
        • Ativo, não recrutando
        • The Centre for Clinical Trials
      • Ottawa, Ontario, Canadá, K1K 4L2
        • Ativo, não recrutando
        • JRB Research Inc.
      • Peterborough, Ontario, Canadá, K9J 5K2
        • Ativo, não recrutando
        • SKiN Centre for Dermatology
      • Toronto, Ontario, Canadá, M4W 2N4
        • Ativo, não recrutando
        • Dermatology on Bloor - Research Toronto
    • Quebec
      • Montreal, Quebec, Canadá, H2X 2V1
        • Ativo, não recrutando
        • Innovaderm Research Inc.
      • Montreal, Quebec, Canadá, H1Y 3L1
        • Ativo, não recrutando
        • Centre de Recherche Saint-Louis
      • Sherbrooke, Quebec, Canadá, J1G 1X9
        • Ativo, não recrutando
        • Centre de Recherche Saint-Louis
  • China
      • Beijing, China, 100050
        • Ativo, não recrutando
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, China, 100730
        • Ativo, não recrutando
        • Beijing Tongren Hospital affiliated to Capital Medical University
      • Nanjing, China, 210029
        • Ativo, não recrutando
        • Nanjing Medical University (NMU) - Jiangsu Province Hospital
      • Shanghai, China, 200062
        • Recrutamento
        • Shanghai Children's Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Ativo, não recrutando
        • China-Japan Friendship Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Ativo, não recrutando
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 100192
        • Ativo, não recrutando
        • China-Japan Friendship Hospital
      • Beijing, Beijing Municipality, China, 100032
        • Ativo, não recrutando
        • Beijing Children's hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Ativo, não recrutando
        • The Second Affiliated Hospital Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Ativo, não recrutando
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510140
        • Ativo, não recrutando
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hunan
      • Changsha, Hunan, China, 410008
        • Ativo, não recrutando
        • Xiangya Hospital Central South University
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Ativo, não recrutando
        • Jiangxi Provincial Children's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Ativo, não recrutando
        • Huashan Hospital, Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Ativo, não recrutando
        • Chengdu second people's hospital
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Ativo, não recrutando
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recrutamento
        • Hangzhou Third Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Ativo, não recrutando
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
  • Coréia do Sul
      • Seoul, Coréia do Sul, 07061
        • Recrutamento
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center Laboratory
    • Chungcheongnam-do [chungnam]
      • Cheonan-si, Chungcheongnam-do [chungnam], Coréia do Sul, 31116
        • Recrutamento
        • Dankook University Hospital
    • Jeonrabugdo
      • Jeonju, Jeonrabugdo, Coréia do Sul, 54907
        • Recrutamento
        • Jeonbuk National University Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Coréia do Sul, 13620
        • Ativo, não recrutando
        • Seoul National University Bundang Hospital
    • Pusan-kwangyǒkshi
      • Busan, Pusan-kwangyǒkshi, Coréia do Sul, 49241
        • Recrutamento
        • Pusan National University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Coréia do Sul, 03080
        • Ativo, não recrutando
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Coréia do Sul, 05030
        • Recrutamento
        • Konkuk University Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], Coréia do Sul, 03312
        • Ativo, não recrutando
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Coréia do Sul, 05278
        • Ativo, não recrutando
        • Kyung Hee University Hospital at Gangdong
    • Taegu-kwangyǒkshi
      • Daegu, Taegu-kwangyǒkshi, Coréia do Sul, 41944
        • Ativo, não recrutando
        • Kyungpook National University Hospital
  • Espanha
      • Madrid, Espanha, 28006
        • Ativo, não recrutando
        • Grupo Pedro Jaén
      • Madrid, Espanha, 28006
        • Ativo, não recrutando
        • Resonancia Magnetica Nuestra Senora del Rosario
      • Zaragoza, Espanha, 50009
        • Ativo, não recrutando
        • Hospital Universitario Miguel Servet
    • A Coruña [LA Coruña]
      • Santiago de Compostela, A Coruña [LA Coruña], Espanha, 15706
        • Ativo, não recrutando
        • CHUS - Hospital Clinico Universitario
    • Andalusia
      • Córdoba, Andalusia, Espanha, 14001
        • Ativo, não recrutando
        • AUDIKA
      • Córdoba, Andalusia, Espanha, 14004
        • Ativo, não recrutando
        • Hospital Universitario Reina Sofia
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Recrutamento
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Estados Unidos, 35233
        • Recrutamento
        • The Kirklin Clinic of UAB Hospital (Radiology)
      • Birmingham, Alabama, Estados Unidos, 35233
        • Recrutamento
        • University of Alabama at Birmingham Faculty Office Towers (Regulatory)
    • Arkansas
      • Hot Springs, Arkansas, Estados Unidos, 71913
        • Ativo, não recrutando
        • Burke Pharmaceutical Research
    • California
      • Brea, California, Estados Unidos, 92821
        • Recrutamento
        • Doc1 Healthcare Systems
      • Encinitas, California, Estados Unidos, 92024
        • Ativo, não recrutando
        • California Dermatology & Clinical Research Institute
      • Huntington Beach, California, Estados Unidos, 92647
        • Ativo, não recrutando
        • Marvel Clinical Research
      • Irvine, California, Estados Unidos, 92617
        • Recrutamento
        • University of California - Irvine
      • Irvine, California, Estados Unidos, 92697
        • Recrutamento
        • Gavin Herbert Eye Institute
      • Santa Ana, California, Estados Unidos, 92701
        • Ativo, não recrutando
        • Southern California Clinical Research
    • Connecticut
      • Fairfield, Connecticut, Estados Unidos, 06824
        • Recrutamento
        • Brett King MD, LLC
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33912
        • Ativo, não recrutando
        • Alliance for Multispecialty Research, LLC
      • Fort Myers, Florida, Estados Unidos, 33912
        • Ativo, não recrutando
        • Robert B. Pritt, DO, PA
      • Miami, Florida, Estados Unidos, 33173
        • Recrutamento
        • Skin Research of South Florida
      • Miami, Florida, Estados Unidos, 33156
        • Recrutamento
        • Pediatric Skin Research
      • Tampa, Florida, Estados Unidos, 33613
        • Ativo, não recrutando
        • ForCare Clinical Research
      • Tampa, Florida, Estados Unidos, 33615
        • Ativo, não recrutando
        • Olympian Clinical Research - Tampa - Memorial Highway
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60625
        • Recrutamento
        • Endeavor Health Audiology -CHICAGO
      • Lake Bluff, Illinois, Estados Unidos, 60044
        • Recrutamento
        • Endeavor Health Audiology -LAKE BLUFF
      • Northbrook, Illinois, Estados Unidos, 60062
        • Recrutamento
        • Endeavor Health Audiology-NORTHBROOK
      • Skokie, Illinois, Estados Unidos, 60077
        • Recrutamento
        • Endeavor Health
      • Skokie, Illinois, Estados Unidos, 60076
        • Recrutamento
        • Endeavor Health Audiology-SKOKIE
      • Skokie, Illinois, Estados Unidos, 60077
        • Recrutamento
        • Endeavor Health Imaging & Radiology Serviccs - Old Orchard
      • Skokie, Illinois, Estados Unidos, 60077
        • Recrutamento
        • Endeavor Health Lab Services - Old Orchard
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46250
        • Recrutamento
        • Dawes Fretzin Clinical Research Group, LLC
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • Recrutamento
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21218
        • Recrutamento
        • Johns Hopkins University
      • Glenn Dale, Maryland, Estados Unidos, 20769
        • Ativo, não recrutando
        • Callender Center for Clinical Research
      • Rockville, Maryland, Estados Unidos, 20850
        • Recrutamento
        • Dermatology and Skin Cancer Specialists, LLC
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Ativo, não recrutando
        • Massachusetts General Hospital
      • Boston, Massachusetts, Estados Unidos, 02111
        • Ativo, não recrutando
        • Tufts Medical Center
      • Boston, Massachusetts, Estados Unidos, 02114
        • Ativo, não recrutando
        • The General Hospital Corporation d/b/a Massachusetts General Hospital
    • Michigan
      • Troy, Michigan, Estados Unidos, 48084
        • Ativo, não recrutando
        • Revival Research Institute, LLC
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Recrutamento
        • University of Minnesota Health Clinical Research Unit (M Health CRU)
      • Minneapolis, Minnesota, Estados Unidos, 55454
        • Recrutamento
        • University of Minnesota Clinics and Surgery Center Department of Radiology
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Recrutamento
        • University of Minnesota Clinics and Surgery Center Department of Audiology
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Recrutamento
        • University of Minnesota Clinics and Surgery Center Department of Radiology
    • New York
      • New York, New York, Estados Unidos, 10029
        • Recrutamento
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27516
        • Ativo, não recrutando
        • UNC Dermatology and Skin Cancer Center
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • Ativo, não recrutando
        • Clinical & Translational Research Center (CTRC)
      • Charlotte, North Carolina, Estados Unidos, 28211
        • Ativo, não recrutando
        • DJL Clinical Research, PLLC
    • Ohio
      • Bexley, Ohio, Estados Unidos, 43209
        • Recrutamento
        • Bexley Dermatology Research
      • Canton, Ohio, Estados Unidos, 44718
        • Ativo, não recrutando
        • Apex Clinical Research Center - Canton
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74136
        • Recrutamento
        • Vital Prospects Clinical Research Institute, PC
    • Oregon
      • Portland, Oregon, Estados Unidos, 97201
        • Ativo, não recrutando
        • Oregon Medical Research Center
      • Portland, Oregon, Estados Unidos, 97210
        • Ativo, não recrutando
        • Northwest Dermatology Institute
      • Portland, Oregon, Estados Unidos, 97210
        • Ativo, não recrutando
        • NW Dermatology Institute
    • Pennsylvania
      • Plymouth Meeting, Pennsylvania, Estados Unidos, 19462
        • Ativo, não recrutando
        • Dermatology Associates of Plymouth Meeting
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Ativo, não recrutando
        • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
      • Myrtle Beach, South Carolina, Estados Unidos, 29588
        • Ativo, não recrutando
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Arlington, Texas, Estados Unidos, 76011
        • Ativo, não recrutando
        • Arlington Research Center
      • Bellaire, Texas, Estados Unidos, 77401
        • Ainda não está recrutando
        • The University of Texas Health Science Center at Houston
      • Dallas, Texas, Estados Unidos, 75230
        • Ativo, não recrutando
        • Dermatology Treatment and Research Center
      • Houston, Texas, Estados Unidos, 77004
        • Recrutamento
        • Center for Clinical Studies
      • San Antonio, Texas, Estados Unidos, 78218
        • Recrutamento
        • Texas Dermatology and Laser Specialists
      • Webster, Texas, Estados Unidos, 77598
        • Recrutamento
        • Center for Clinical Studies - Clear Lake
    • Utah
      • Layton, Utah, Estados Unidos, 84041
        • Ativo, não recrutando
        • AMR Clinical
      • Murray, Utah, Estados Unidos, 84107
        • Ativo, não recrutando
        • University of Utah
    • Washington
      • Spokane, Washington, Estados Unidos, 99202
        • Ativo, não recrutando
        • Dermatology Specialists of Spokane
      • Spokane, Washington, Estados Unidos, 99202
        • Ativo, não recrutando
        • Principle Research Solutions
  • Japão
      • Osaka, Japão, 545-8586
        • Ativo, não recrutando
        • Osaka Metropolitan University Hospital
    • Fukuoka
      • Kurume, Fukuoka, Japão, 830-0011
        • Ativo, não recrutando
        • Kurume University Hospital
    • Miyagi
      • Sendai, Miyagi, Japão, 980-8574
        • Ativo, não recrutando
        • Tohoku University Hospital
    • Niigata
      • Niigata, Niigata, Japão, 951-8520
        • Ativo, não recrutando
        • Niigata University Medical & Dental Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japão, 431-3192
        • Recrutamento
        • Hamamatsu University Hospital
    • Tokyo
      • Koto-ku, Tokyo, Japão, 136-0075
        • Recrutamento
        • Juntendo Tokyo Koto Geriatric Medical Center
      • Mitaka, Tokyo, Japão, 181-8611
        • Recrutamento
        • Kyorin University Hospital
      • Shinjuku-ku, Tokyo, Japão, 160-0023
        • Recrutamento
        • Tokyo Medical University Hospital
  • Polônia
      • Gdansk, Polônia, 80-546
        • Ativo, não recrutando
        • Penta Hospitals Badania Kliniczne sp. z o.o.
      • Ostrowiec Świętokrzyski, Polônia, 27-400
        • Ativo, não recrutando
        • DERMEDIC Iwona Zdybska
      • Warsaw, Polônia, 00-124
        • Ativo, não recrutando
        • NZOZ GynCentrum - Oddział Warszawa
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polônia, 60-324
        • Ativo, não recrutando
        • Twoja Przychodnia PCM
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polônia, 30-002
        • Ativo, não recrutando
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polônia, 50-566
        • Ativo, não recrutando
        • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polônia, 20-607
        • Ativo, não recrutando
        • DERMEDIC Iwona Zdybska
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Polônia, 67-100
        • Ativo, não recrutando
        • Twoja Przychodnia NCM
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polônia, 00-716
        • Ativo, não recrutando
        • Klinika Osipowicz & Turkowski
      • Warsaw, Masovian Voivodeship, Polônia, 01-018
        • Ativo, não recrutando
        • Dr Sękowska Leczenie Bólu
      • Warsaw, Masovian Voivodeship, Polônia, 02-962
        • Ativo, não recrutando
        • Royalderm Agnieszka Nawrocka
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polônia, 40-611
        • Ativo, não recrutando
        • Centrum Medyczne Angelius Provita
      • Sosnowiec, Silesian Voivodeship, Polônia, 41-200
        • Ativo, não recrutando
        • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polônia, 71-500
        • Ativo, não recrutando
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Porto Rico
      • San Juan, Porto Rico, 00917
        • Ativo, não recrutando
        • GCM Medical Group, PSC - Hato Rey Site
  • Reino Unido
      • London, Reino Unido, SE1 7EH
        • Ativo, não recrutando
        • Guy's & St Thomas' NHS Foundation Trust
    • Brighton AND HOVE
      • East Sussex, Brighton AND HOVE, Reino Unido, BN2 1ES
        • Ativo, não recrutando
        • University Hospitals Sussex NHS Foundation Trust
    • Dundee CITY
      • Dundee, Dundee CITY, Reino Unido, DD1 9SY
        • Ativo, não recrutando
        • Ninewells Hospital and Medical School
    • England
      • London, England, Reino Unido, SW10 9NH
        • Ativo, não recrutando
        • Chelsea and Westminster Hospital NHS Foundation Trust
    • London, CITY of
      • London, London, CITY of, Reino Unido, SE1 9RT
        • Ativo, não recrutando
        • Guy's & St Thomas' NHS Foundation Trust
    • WEST Sussex
      • Worthing, WEST Sussex, Reino Unido, BN11 2DH
        • Ativo, não recrutando
        • University Hospitals Sussex NHS Foundation Trust
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Ativo, não recrutando
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taipei, Taiwan, 11217
        • Ativo, não recrutando
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Ativo, não recrutando
        • Chang Gung Medical Foundation-Linkou Branch
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Ativo, não recrutando
        • Chang Gung Memorial Hospital at Kaohsiung
  • Tcheca
      • Pardubice, Tcheca, 53002
        • Ativo, não recrutando
        • Pratia Czech s.r.o.
    • Plzeň Region
      • Pilsen, Plzeň Region, Tcheca, 301 00
        • Ativo, não recrutando
        • Fakultni Nemocnice Plzen
    • Praha 6
      • Prague, Praha 6, Tcheca, 160 00
        • Ativo, não recrutando
        • Kozni ambulance Fialova s.r.o

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Age:

  1. 18 years of age or older at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled. In Part 2 of the study, only adolescents (12 to <18 years of age at both Screening and Day 1) who did not participate in Part 1 will be enrolled.

    Disease Characteristics:

  2. Must meet the following alopecia areata criteria at both Screening and Baseline:

    1. Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
    2. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
    3. Current episode of hair loss ≤10 years.

Exclusion Criteria:

Medical Conditions:

  1. Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss.

  2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.

  3. Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.

  4. General Infection History:

    • Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.
    • Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves.
    • Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.

  5. Specific Viral Infection History:

    • History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
    • Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.

  6. Other Medical Conditions:

    • Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive.
    • Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening.
    • Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    • Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
    • Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery.

  7. Adolescent participants 12 to <18 years of age without one of the following:

    • Documented evidence from a health professional of having received varicella vaccination (2 doses); or
    • Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening.

  8. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

    Prior/Concomitant Therapy:

  9. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.

    Prior/Concurrent Clinical Study Experience:

  10. Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (whichever is longer) before the first dose of study intervention in this study. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study. Receipt of study intervention in Study B7981094 or other studies of ritlecitinib.

    Diagnostic Assessments:

  11. Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.

  12. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.

    Other Exclusion Criteria:

  13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Ritlecitinib 50 mg

Participants in Part 1 will be randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks. Data from participants who are non-responders (ie, had a SALT score greater than 20) at Week 24 and re-randomized to Ritlecitinib 50 mg will be augmented with data from an External Ritlecitinib 50 mg QD Group for comparisons at Week 48. The External Ritlecitinib 50 mg QD Group will be constructed using patient-level data from the appropriately chosen Pfizer clinical study in participants who received Ritlecitinib 50 mg QD and were non-responders at Week 24 and continued receiving ritlecitinib 50 mg QD up to Week 48.

In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.
Medicamento: Ritlecitinib 50 mg

50 mg Capsule

Outros nomes:
  • PF-06651600
  • Litfolo
Medicamento: Placebo - 100 mg

Capsule (to match Ritlecitinib 100 mg)
Sem intervenção: External Placebo

This group will be constructed using participant-level data at Week 24 from placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata. This data will be used for comparison between each Ritlecitinib dose and placebo at Week 24.

As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.
Experimental: Ritlecitinib 100 mg (open-label)

Participants in Part 2 will be assigned to receive one open-label Ritlecitinib 100 mg capsule once daily by mouth for 48 weeks.
Medicamento: Ritlecitinib 100 mg

100 mg Capsule

Outros nomes:
  • PF-06651600
  • Litfolo
Experimental: Ritlecitinib 100 mg

Participants in Part 1 will be randomized to Ritlecitinib 100 mg QD for 48 weeks.

In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.
Medicamento: Ritlecitinib 100 mg

100 mg Capsule

Outros nomes:
  • PF-06651600
  • Litfolo
Medicamento: Placebo - 50 mg

Capsule (to match Ritlecitinib 50 mg)
Sem intervenção: Synthetic Placebo

This group will be constructed using participant-level data up to Week 36 from the placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata and a longitudinal model and extrapolation. This data will be used for comparison between Ritlecitinib 100 mg and placebo at Week 36.

As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
Prazo: Week 24

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo
Week 24
Part 2: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation
Prazo: Baseline to Follow-up visit (Week 52)

Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD
Baseline to Follow-up visit (Week 52)
Part 2: Percentage of participants with clinically significant laboratory abnormalities
Prazo: Baseline to Follow-up visit (Week 52)

Percentage of participants with clinically significant laboratory abnormalities, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD
Baseline to Follow-up visit (Week 52)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Prazo: Week 24

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: EU Only: Percentage of participants with Patient Global Impression of Change (PGI-C) response, defined as a score of "moderately improved" or "greatly improved"
Prazo: Week 24

Difference in percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: US Only: Percentage of participants with absolute SALT score less than or equal to 20
Prazo: Week 36

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus placebo
Week 36
Part 1: Change from baseline in SALT score
Prazo: Week 24

Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Week 24
Part 1: Percentage of participants with absolute SALT score equal to 0
Prazo: Week 24

Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Prazo: Baseline through Week 24

Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Prazo: Baseline through Week 24

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score equal to 0
Prazo: Baseline through Week 24

Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Change from baseline in SALT score
Prazo: Baseline through Week 24

Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Prazo: Baseline through Week 24

Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Prazo: Baseline through Week 24

Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Prazo: Baseline through Week 24

Difference in the percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Prazo: Week 24

Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Prazo: Week 24

Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Prazo: Week 24

Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Prazo: Week 48

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg non-responder (NR)-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Prazo: Week 48

Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Change from Week 24 in SALT score
Prazo: Week 48

Difference in the mean absolute change from Week 24 in SALT score between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Prazo: Week 48

Percentage of participants with PGI-C response between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Prazo: Week 24 through Week 48

Percentage of participants with SALT score less than or equal to 20 for ritlecitinib 100 mg QD, ritlecitinib 50 mg responder (R)-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Prazo: Week 24 through Week 48

Percentage of participants with SALT score less than or equal to 10 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with absolute SALT score equal to 0
Prazo: Week 24 through Week 48

Percentage of participants with SALT score equal to 0 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Change from Week 24 in SALT score
Prazo: Week 24 through Week 48

Mean absolute change from Week 24 in SALT score for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Prazo: Week 24 through Week 48

Percentage of participants with EBA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Prazo: Week 24 through Week 48

Percentage of participants with ELA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Prazo: Week 24 through Week 48

Percentage of participants with PGI-C response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 2: Percentage of participants with absolute SALT score less than or equal to 20
Prazo: Baseline through Week 48

Percentage of participants with absolute SALT score less than or equal to 20 for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with absolute SALT score less than or equal to 10
Prazo: Baseline through Week 48

Percentage of participants with absolute SALT score less than or equal to 10 for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with absolute SALT score equal to 0
Prazo: Baseline through Week 48

Percentage of participants with absolute SALT score equal to 0 for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Change from baseline in SALT score
Prazo: Baseline through Week 48

Mean change from baseline in SALT score for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Prazo: Baseline through Week 48

Percentage of participants with EBA response for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Prazo: Baseline through Week 48

Percentage of participants with ELA response for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Prazo: Baseline through Week 48

Percentage of participants with PGI-C response for ritlecitinib 100 mg QD
Baseline through Week 48
Part 1: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation
Prazo: Baseline to Follow-up visit (Week 52)

Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD and ritlecitinib 50 mg
Baseline to Follow-up visit (Week 52)
Part 1: Percentage of participants with clinically significant laboratory abnormalities
Prazo: Baseline to Follow-up visit (Week 52)

Percentage of participants with clinically significant laboratory abnormalities, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD and ritlecitinib 50 mg
Baseline to Follow-up visit (Week 52)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Investigadores

  • Diretor de estudo: Pfizer CT.gov Call Center, Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2025

Conclusão Primária (Estimado)

19 de março de 2028

Conclusão do estudo (Estimado)

19 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

7 de março de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de março de 2025

Primeira postagem (Real)

13 de março de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • B7981094
  • 2024-519370-40-00 (Identificador de registro: CTIS (EU))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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