Un estudio de 2 dosis de ritlecitinib en personas de 12 años y mayores con alopecia areata (ALLEGRO-100)
Un estudio aleatorizado de fase 3, externo y sintético con placebo con placebo con dosis para que no respondan para investigar la seguridad y la eficacia de ritlecitinib 50 mg y 100 mg una vez al día en participantes adultos y adolescentes de 12 años y mayores con 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Acceso ampliado
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pfizer CT.gov Call Center
- Número de teléfono: 1-800-718-1021
- Correo electrónico: ClinicalTrials.gov_Inquiries@pfizer.com
Ubicaciones de estudio
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Québec, Canadá, G1V 3V9
- Activo, no reclutando
- Centre de Recherche Saint-Louis
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Québec, Canadá, G1V 4X7
- Activo, no reclutando
- Centre de Recherche Dermatologique du Quebec metropolitain
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Québec, Canadá, G1W 4R4
- Activo, no reclutando
- Centre de Recherche Saint-Louis inc.
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Alberta
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Calgary, Alberta, Canadá, T2J 7E1
- Activo, no reclutando
- Dermatology Research Institute
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Red Deer, Alberta, Canadá, T4P 1K4
- Activo, no reclutando
- CaRe Clinic
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Manitoba
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Winnipeg, Manitoba, Canadá, R3M 3Z4
- Activo, no reclutando
- Wiseman Dermatology Research Inc.
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Ontario
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Barrie, Ontario, Canadá, L4M 7G1
- Activo, no reclutando
- SimcoDerm Medical and Surgical Dermatology Center
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Guelph, Ontario, Canadá, N1L 0B7
- Activo, no reclutando
- Guelph Dermatology Research
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London, Ontario, Canadá, N6H 5L5
- Activo, no reclutando
- DermEffects
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Markham, Ontario, Canadá, L3P 1X3
- Activo, no reclutando
- Lynderm Research Inc.
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Newmarket, Ontario, Canadá, L3Y 5G8
- Activo, no reclutando
- Ryan Clinical Research Inc.
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Oakville, Ontario, Canadá, L6J 7W5
- Activo, no reclutando
- The Centre for Clinical Trials
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Ottawa, Ontario, Canadá, K1K 4L2
- Activo, no reclutando
- JRB Research Inc.
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Peterborough, Ontario, Canadá, K9J 5K2
- Activo, no reclutando
- SKiN Centre for Dermatology
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Toronto, Ontario, Canadá, M4W 2N4
- Activo, no reclutando
- Dermatology on Bloor - Research Toronto
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Quebec
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Montreal, Quebec, Canadá, H2X 2V1
- Activo, no reclutando
- Innovaderm Research Inc.
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Montreal, Quebec, Canadá, H1Y 3L1
- Activo, no reclutando
- Centre de Recherche Saint-Louis
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Sherbrooke, Quebec, Canadá, J1G 1X9
- Activo, no reclutando
- Centre de Recherche Saint-Louis
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Pardubice, Chequia, 53002
- Activo, no reclutando
- Pratia Czech s.r.o.
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Plzeň Region
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Pilsen, Plzeň Region, Chequia, 301 00
- Activo, no reclutando
- Fakultni Nemocnice Plzen
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Praha 6
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Prague, Praha 6, Chequia, 160 00
- Activo, no reclutando
- Kozni ambulance Fialova s.r.o
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Seoul, Corea del Sur, 07061
- Reclutamiento
- Seoul Metropolitan Government Seoul National University Boramae Medical Center Laboratory
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Chungcheongnam-do [chungnam]
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Cheonan-si, Chungcheongnam-do [chungnam], Corea del Sur, 31116
- Reclutamiento
- Dankook University Hospital
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Jeonrabugdo
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Jeonju, Jeonrabugdo, Corea del Sur, 54907
- Reclutamiento
- Jeonbuk National University Hospital
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, Corea del Sur, 13620
- Activo, no reclutando
- Seoul National University Bundang Hospital
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Pusan-kwangyǒkshi
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Busan, Pusan-kwangyǒkshi, Corea del Sur, 49241
- Reclutamiento
- Pusan National University Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 03080
- Activo, no reclutando
- Seoul National University Hospital
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 05030
- Reclutamiento
- Konkuk University Medical Center
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 03312
- Activo, no reclutando
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 05278
- Activo, no reclutando
- Kyung Hee University Hospital at Gangdong
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Taegu-kwangyǒkshi
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Daegu, Taegu-kwangyǒkshi, Corea del Sur, 41944
- Activo, no reclutando
- Kyungpook National University Hospital
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Madrid, España, 28006
- Activo, no reclutando
- Grupo Pedro Jaén
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Madrid, España, 28006
- Activo, no reclutando
- Resonancia Magnetica Nuestra Senora del Rosario
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Zaragoza, España, 50009
- Activo, no reclutando
- Hospital Universitario Miguel Servet
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A Coruña [LA Coruña]
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Santiago de Compostela, A Coruña [LA Coruña], España, 15706
- Activo, no reclutando
- CHUS - Hospital Clinico Universitario
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Andalusia
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Córdoba, Andalusia, España, 14001
- Activo, no reclutando
- AUDIKA
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Córdoba, Andalusia, España, 14004
- Activo, no reclutando
- Hospital Universitario Reina Sofia
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Reclutamiento
- University of Alabama at Birmingham
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Birmingham, Alabama, Estados Unidos, 35233
- Reclutamiento
- The Kirklin Clinic of UAB Hospital (Radiology)
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Birmingham, Alabama, Estados Unidos, 35233
- Reclutamiento
- University of Alabama at Birmingham Faculty Office Towers (Regulatory)
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Arkansas
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Hot Springs, Arkansas, Estados Unidos, 71913
- Activo, no reclutando
- Burke Pharmaceutical Research
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California
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Brea, California, Estados Unidos, 92821
- Reclutamiento
- Doc1 Healthcare Systems
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Encinitas, California, Estados Unidos, 92024
- Activo, no reclutando
- California Dermatology & Clinical Research Institute
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Huntington Beach, California, Estados Unidos, 92647
- Activo, no reclutando
- Marvel Clinical Research
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Irvine, California, Estados Unidos, 92617
- Reclutamiento
- University of California - Irvine
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Irvine, California, Estados Unidos, 92697
- Reclutamiento
- Gavin Herbert Eye Institute
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Santa Ana, California, Estados Unidos, 92701
- Activo, no reclutando
- Southern California Clinical Research
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Connecticut
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Fairfield, Connecticut, Estados Unidos, 06824
- Reclutamiento
- Brett King MD, LLC
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Florida
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Fort Myers, Florida, Estados Unidos, 33912
- Activo, no reclutando
- Alliance for Multispecialty Research, LLC
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Fort Myers, Florida, Estados Unidos, 33912
- Activo, no reclutando
- Robert B. Pritt, DO, PA
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Miami, Florida, Estados Unidos, 33173
- Reclutamiento
- Skin Research of South Florida
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Miami, Florida, Estados Unidos, 33156
- Reclutamiento
- Pediatric Skin Research
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Tampa, Florida, Estados Unidos, 33613
- Activo, no reclutando
- ForCare Clinical Research
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Tampa, Florida, Estados Unidos, 33615
- Activo, no reclutando
- Olympian Clinical Research - Tampa - Memorial Highway
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Illinois
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Chicago, Illinois, Estados Unidos, 60625
- Reclutamiento
- Endeavor Health Audiology -CHICAGO
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Lake Bluff, Illinois, Estados Unidos, 60044
- Reclutamiento
- Endeavor Health Audiology -LAKE BLUFF
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Northbrook, Illinois, Estados Unidos, 60062
- Reclutamiento
- Endeavor Health Audiology-NORTHBROOK
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Skokie, Illinois, Estados Unidos, 60077
- Reclutamiento
- Endeavor Health
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Skokie, Illinois, Estados Unidos, 60076
- Reclutamiento
- Endeavor Health Audiology-SKOKIE
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Skokie, Illinois, Estados Unidos, 60077
- Reclutamiento
- Endeavor Health Imaging & Radiology Serviccs - Old Orchard
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Skokie, Illinois, Estados Unidos, 60077
- Reclutamiento
- Endeavor Health Lab Services - Old Orchard
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46250
- Reclutamiento
- Dawes Fretzin Clinical Research Group, LLC
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Reclutamiento
- University of Iowa
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Maryland
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Baltimore, Maryland, Estados Unidos, 21218
- Reclutamiento
- Johns Hopkins University
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Glenn Dale, Maryland, Estados Unidos, 20769
- Activo, no reclutando
- Callender Center for Clinical Research
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Rockville, Maryland, Estados Unidos, 20850
- Reclutamiento
- Dermatology and Skin Cancer Specialists, LLC
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Activo, no reclutando
- Massachusetts General Hospital
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Boston, Massachusetts, Estados Unidos, 02111
- Activo, no reclutando
- Tufts Medical Center
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Boston, Massachusetts, Estados Unidos, 02114
- Activo, no reclutando
- The General Hospital Corporation d/b/a Massachusetts General Hospital
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Michigan
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Troy, Michigan, Estados Unidos, 48084
- Activo, no reclutando
- Revival Research Institute, LLC
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University of Minnesota Health Clinical Research Unit (M Health CRU)
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Minneapolis, Minnesota, Estados Unidos, 55454
- Reclutamiento
- University of Minnesota Clinics and Surgery Center Department of Radiology
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Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University of Minnesota Clinics and Surgery Center Department of Audiology
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Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University of Minnesota Clinics and Surgery Center Department of Radiology
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New York
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New York, New York, Estados Unidos, 10029
- Reclutamiento
- Icahn School of Medicine at Mount Sinai
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27516
- Activo, no reclutando
- UNC Dermatology and Skin Cancer Center
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Activo, no reclutando
- Clinical & Translational Research Center (CTRC)
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Charlotte, North Carolina, Estados Unidos, 28211
- Activo, no reclutando
- DJL Clinical Research, PLLC
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Ohio
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Bexley, Ohio, Estados Unidos, 43209
- Reclutamiento
- Bexley Dermatology Research
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Canton, Ohio, Estados Unidos, 44718
- Activo, no reclutando
- Apex Clinical Research Center - Canton
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Reclutamiento
- Vital Prospects Clinical Research Institute, PC
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Oregon
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Portland, Oregon, Estados Unidos, 97201
- Activo, no reclutando
- Oregon Medical Research Center
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Portland, Oregon, Estados Unidos, 97210
- Activo, no reclutando
- Northwest Dermatology Institute
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Portland, Oregon, Estados Unidos, 97210
- Activo, no reclutando
- NW Dermatology Institute
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Pennsylvania
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Plymouth Meeting, Pennsylvania, Estados Unidos, 19462
- Activo, no reclutando
- Dermatology Associates of Plymouth Meeting
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Activo, no reclutando
- Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
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Myrtle Beach, South Carolina, Estados Unidos, 29588
- Activo, no reclutando
- Alliance for Multispecialty Research, LLC
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Texas
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Arlington, Texas, Estados Unidos, 76011
- Activo, no reclutando
- Arlington Research Center
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Bellaire, Texas, Estados Unidos, 77401
- Aún no reclutando
- The University of Texas Health Science Center at Houston
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Dallas, Texas, Estados Unidos, 75230
- Activo, no reclutando
- Dermatology Treatment and Research Center
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Houston, Texas, Estados Unidos, 77004
- Reclutamiento
- Center for Clinical Studies
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San Antonio, Texas, Estados Unidos, 78218
- Reclutamiento
- Texas Dermatology and Laser Specialists
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Webster, Texas, Estados Unidos, 77598
- Reclutamiento
- Center for Clinical Studies - Clear Lake
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Utah
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Layton, Utah, Estados Unidos, 84041
- Activo, no reclutando
- AMR Clinical
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Murray, Utah, Estados Unidos, 84107
- Activo, no reclutando
- University of Utah
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Washington
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Spokane, Washington, Estados Unidos, 99202
- Activo, no reclutando
- Dermatology Specialists of Spokane
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Spokane, Washington, Estados Unidos, 99202
- Activo, no reclutando
- Principle Research Solutions
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Osaka, Japón, 545-8586
- Activo, no reclutando
- Osaka Metropolitan University Hospital
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Fukuoka
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Kurume, Fukuoka, Japón, 830-0011
- Activo, no reclutando
- Kurume University Hospital
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Miyagi
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Sendai, Miyagi, Japón, 980-8574
- Activo, no reclutando
- Tohoku University Hospital
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Niigata
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Niigata, Niigata, Japón, 951-8520
- Activo, no reclutando
- Niigata University Medical & Dental Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japón, 431-3192
- Reclutamiento
- Hamamatsu University Hospital
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Tokyo
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Koto-ku, Tokyo, Japón, 136-0075
- Reclutamiento
- Juntendo Tokyo Koto Geriatric Medical Center
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Mitaka, Tokyo, Japón, 181-8611
- Reclutamiento
- Kyorin University Hospital
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Shinjuku-ku, Tokyo, Japón, 160-0023
- Reclutamiento
- Tokyo Medical University Hospital
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Gdansk, Polonia, 80-546
- Activo, no reclutando
- Penta Hospitals Badania Kliniczne sp. z o.o.
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Ostrowiec Świętokrzyski, Polonia, 27-400
- Activo, no reclutando
- DERMEDIC Iwona Zdybska
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Warsaw, Polonia, 00-124
- Activo, no reclutando
- NZOZ GynCentrum - Oddział Warszawa
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia, 60-324
- Activo, no reclutando
- Twoja Przychodnia PCM
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-002
- Activo, no reclutando
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polonia, 50-566
- Activo, no reclutando
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 20-607
- Activo, no reclutando
- DERMEDIC Iwona Zdybska
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, Polonia, 67-100
- Activo, no reclutando
- Twoja Przychodnia NCM
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 00-716
- Activo, no reclutando
- Klinika Osipowicz & Turkowski
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Warsaw, Masovian Voivodeship, Polonia, 01-018
- Activo, no reclutando
- Dr Sękowska Leczenie Bólu
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Warsaw, Masovian Voivodeship, Polonia, 02-962
- Activo, no reclutando
- Royalderm Agnieszka Nawrocka
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polonia, 40-611
- Activo, no reclutando
- Centrum Medyczne Angelius Provita
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Sosnowiec, Silesian Voivodeship, Polonia, 41-200
- Activo, no reclutando
- Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polonia, 71-500
- Activo, no reclutando
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Beijing, Porcelana, 100050
- Activo, no reclutando
- Beijing Friendship hospital, Capital Medical University
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Beijing, Porcelana, 100730
- Activo, no reclutando
- Beijing Tongren Hospital affiliated to Capital Medical University
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Nanjing, Porcelana, 210029
- Activo, no reclutando
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
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Shanghai, Porcelana, 200062
- Reclutamiento
- Shanghai Children's Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Activo, no reclutando
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, Porcelana, 100044
- Activo, no reclutando
- Peking University People's Hospital
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Beijing, Beijing Municipality, Porcelana, 100192
- Activo, no reclutando
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, Porcelana, 100032
- Activo, no reclutando
- Beijing Children's hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400010
- Activo, no reclutando
- The Second Affiliated Hospital Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510120
- Activo, no reclutando
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, Porcelana, 510140
- Activo, no reclutando
- The First Affiliated Hospital of Guangzhou Medical University
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Hunan
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Changsha, Hunan, Porcelana, 410008
- Activo, no reclutando
- Xiangya Hospital Central South University
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Jiangxi
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Nanchang, Jiangxi, Porcelana
- Activo, no reclutando
- Jiangxi Provincial Children's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200040
- Activo, no reclutando
- Huashan Hospital, Fudan University
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Sichuan
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Chengdu, Sichuan, Porcelana, 610017
- Activo, no reclutando
- Chengdu second people's hospital
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Yunnan
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Kunming, Yunnan, Porcelana, 650032
- Activo, no reclutando
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310009
- Reclutamiento
- Hangzhou Third Hospital
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Hangzhou, Zhejiang, Porcelana, 310016
- Activo, no reclutando
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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-
-
-
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San Juan, Puerto Rico, 00917
- Activo, no reclutando
- GCM Medical Group, PSC - Hato Rey Site
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-
-
-
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London, Reino Unido, SE1 7EH
- Activo, no reclutando
- Guy's & St Thomas' NHS Foundation Trust
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Brighton AND HOVE
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East Sussex, Brighton AND HOVE, Reino Unido, BN2 1ES
- Activo, no reclutando
- University Hospitals Sussex NHS Foundation Trust
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Dundee CITY
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Dundee, Dundee CITY, Reino Unido, DD1 9SY
- Activo, no reclutando
- Ninewells Hospital and Medical School
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England
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London, England, Reino Unido, SW10 9NH
- Activo, no reclutando
- Chelsea and Westminster Hospital NHS Foundation Trust
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London, CITY of
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London, London, CITY of, Reino Unido, SE1 9RT
- Activo, no reclutando
- Guy's & St Thomas' NHS Foundation Trust
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WEST Sussex
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Worthing, WEST Sussex, Reino Unido, BN11 2DH
- Activo, no reclutando
- University Hospitals Sussex NHS Foundation Trust
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-
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Kaohsiung City, Taiwán, 80756
- Activo, no reclutando
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taipei, Taiwán, 11217
- Activo, no reclutando
- Taipei Veterans General Hospital
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Taoyuan, Taiwán, 333
- Activo, no reclutando
- Chang Gung Medical Foundation-Linkou Branch
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Kaohsiung
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Kaohsiung Niao Sung Dist, Kaohsiung, Taiwán, 83301
- Activo, no reclutando
- Chang Gung Memorial Hospital at Kaohsiung
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Age:
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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:
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Must meet the following alopecia areata criteria at both Screening and Baseline:
- Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
- ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
- Current episode of hair loss ≤10 years.
Exclusion Criteria:
Medical Conditions:
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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.
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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.
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Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
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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.
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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.
-
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.
-
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.
-
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:
-
Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.
Prior/Concurrent Clinical Study Experience:
-
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:
-
Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
-
Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.
Other Exclusion Criteria:
-
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
50 mg Capsule
Otros nombres:
Capsule (to match Ritlecitinib 100 mg) |
|
Sin intervención: 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. |
100 mg Capsule
Otros nombres:
|
|
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. |
100 mg Capsule
Otros nombres:
Capsule (to match Ritlecitinib 50 mg) |
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Periodo de tiempo: 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"
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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"
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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"
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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"
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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"
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B7981094
- 2024-519370-40-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .