탈모증 Areata와 함께 12 세 이상의 사람들에서 2 회 복용량의 리틀에 시티 닙에 대한 연구 (ALLEGRO-100)
3 상, 외부 및 합성 위약 제어 무작위 연구는 비 응답자에 대한 복용량 업을 통해 Ritlecitinib 50 mg 및 100 mg의 성인 및 청소년 참가자에서 12 세 이상의 AREATA를 사용하여 100 mg의 안전성 및 효능을 조사하기위한 복용량 업 연구
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 3단계
확장된 액세스
연락처 및 위치
연구 연락처
- 이름: Pfizer CT.gov Call Center
- 전화번호: 1-800-718-1021
- 이메일: ClinicalTrials.gov_Inquiries@pfizer.com
연구 장소
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Kaohsiung City, 대만, 80756
- 모집하지 않고 적극적으로
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taipei, 대만, 11217
- 모집하지 않고 적극적으로
- Taipei Veterans General Hospital
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Taoyuan, 대만, 333
- 모집하지 않고 적극적으로
- Chang Gung Medical Foundation-Linkou Branch
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Kaohsiung
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Kaohsiung Niao Sung Dist, Kaohsiung, 대만, 83301
- 모집하지 않고 적극적으로
- Chang Gung Memorial Hospital at Kaohsiung
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Seoul, 대한민국, 07061
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- 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], 대한민국, 31116
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- Dankook University Hospital
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Jeonrabugdo
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Jeonju, Jeonrabugdo, 대한민국, 54907
- 모병
- Jeonbuk National University Hospital
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, 대한민국, 13620
- 모집하지 않고 적극적으로
- Seoul National University Bundang Hospital
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Pusan-kwangyǒkshi
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Busan, Pusan-kwangyǒkshi, 대한민국, 49241
- 모병
- Pusan National University Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], 대한민국, 03080
- 모집하지 않고 적극적으로
- Seoul National University Hospital
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Seoul, Seoul-teukbyeolsi [seoul], 대한민국, 05030
- 모병
- Konkuk University Medical Center
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Seoul, Seoul-teukbyeolsi [seoul], 대한민국, 03312
- 모집하지 않고 적극적으로
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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Seoul, Seoul-teukbyeolsi [seoul], 대한민국, 05278
- 모집하지 않고 적극적으로
- Kyung Hee University Hospital at Gangdong
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Taegu-kwangyǒkshi
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Daegu, Taegu-kwangyǒkshi, 대한민국, 41944
- 모집하지 않고 적극적으로
- Kyungpook National University Hospital
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Alabama
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Birmingham, Alabama, 미국, 35233
- 모병
- University of Alabama at Birmingham
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Birmingham, Alabama, 미국, 35233
- 모병
- The Kirklin Clinic of UAB Hospital (Radiology)
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Birmingham, Alabama, 미국, 35233
- 모병
- University of Alabama at Birmingham Faculty Office Towers (Regulatory)
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Arkansas
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Hot Springs, Arkansas, 미국, 71913
- 모집하지 않고 적극적으로
- Burke Pharmaceutical Research
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California
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Brea, California, 미국, 92821
- 모병
- Doc1 Healthcare Systems
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Encinitas, California, 미국, 92024
- 모집하지 않고 적극적으로
- California Dermatology & Clinical Research Institute
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Huntington Beach, California, 미국, 92647
- 모집하지 않고 적극적으로
- Marvel Clinical Research
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Irvine, California, 미국, 92617
- 모병
- University of California - Irvine
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Irvine, California, 미국, 92697
- 모병
- Gavin Herbert Eye Institute
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Santa Ana, California, 미국, 92701
- 모집하지 않고 적극적으로
- Southern California Clinical Research
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Connecticut
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Fairfield, Connecticut, 미국, 06824
- 모병
- Brett King MD, LLC
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Florida
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Fort Myers, Florida, 미국, 33912
- 모집하지 않고 적극적으로
- Alliance for Multispecialty Research, LLC
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Fort Myers, Florida, 미국, 33912
- 모집하지 않고 적극적으로
- Robert B. Pritt, DO, PA
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Miami, Florida, 미국, 33173
- 모병
- Skin Research of South Florida
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Miami, Florida, 미국, 33156
- 모병
- Pediatric Skin Research
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Tampa, Florida, 미국, 33613
- 모집하지 않고 적극적으로
- ForCare Clinical Research
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Tampa, Florida, 미국, 33615
- 모집하지 않고 적극적으로
- Olympian Clinical Research - Tampa - Memorial Highway
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Illinois
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Chicago, Illinois, 미국, 60625
- 모병
- Endeavor Health Audiology -CHICAGO
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Lake Bluff, Illinois, 미국, 60044
- 모병
- Endeavor Health Audiology -LAKE BLUFF
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Northbrook, Illinois, 미국, 60062
- 모병
- Endeavor Health Audiology-NORTHBROOK
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Skokie, Illinois, 미국, 60077
- 모병
- Endeavor Health
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Skokie, Illinois, 미국, 60076
- 모병
- Endeavor Health Audiology-SKOKIE
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Skokie, Illinois, 미국, 60077
- 모병
- Endeavor Health Imaging & Radiology Serviccs - Old Orchard
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Skokie, Illinois, 미국, 60077
- 모병
- Endeavor Health Lab Services - Old Orchard
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Indiana
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Indianapolis, Indiana, 미국, 46250
- 모병
- Dawes Fretzin Clinical Research Group, LLC
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Iowa
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Iowa City, Iowa, 미국, 52242
- 모병
- University of Iowa
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Maryland
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Baltimore, Maryland, 미국, 21218
- 모병
- Johns Hopkins University
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Glenn Dale, Maryland, 미국, 20769
- 모집하지 않고 적극적으로
- Callender Center for Clinical Research
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Rockville, Maryland, 미국, 20850
- 모병
- Dermatology and Skin Cancer Specialists, LLC
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모집하지 않고 적극적으로
- Massachusetts General Hospital
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Boston, Massachusetts, 미국, 02111
- 모집하지 않고 적극적으로
- Tufts Medical Center
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Boston, Massachusetts, 미국, 02114
- 모집하지 않고 적극적으로
- The General Hospital Corporation d/b/a Massachusetts General Hospital
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Michigan
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Troy, Michigan, 미국, 48084
- 모집하지 않고 적극적으로
- Revival Research Institute, LLC
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- 모병
- University of Minnesota Health Clinical Research Unit (M Health CRU)
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Minneapolis, Minnesota, 미국, 55454
- 모병
- University of Minnesota Clinics and Surgery Center Department of Radiology
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Minneapolis, Minnesota, 미국, 55455
- 모병
- University of Minnesota Clinics and Surgery Center Department of Audiology
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Minneapolis, Minnesota, 미국, 55455
- 모병
- University of Minnesota Clinics and Surgery Center Department of Radiology
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New York
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New York, New York, 미국, 10029
- 모병
- Icahn School of Medicine at Mount Sinai
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North Carolina
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Chapel Hill, North Carolina, 미국, 27516
- 모집하지 않고 적극적으로
- UNC Dermatology and Skin Cancer Center
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Chapel Hill, North Carolina, 미국, 27599
- 모집하지 않고 적극적으로
- Clinical & Translational Research Center (CTRC)
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Charlotte, North Carolina, 미국, 28211
- 모집하지 않고 적극적으로
- DJL Clinical Research, PLLC
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Ohio
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Bexley, Ohio, 미국, 43209
- 모병
- Bexley Dermatology Research
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Canton, Ohio, 미국, 44718
- 모집하지 않고 적극적으로
- Apex Clinical Research Center - Canton
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Oklahoma
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Tulsa, Oklahoma, 미국, 74136
- 모병
- Vital Prospects Clinical Research Institute, PC
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Oregon
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Portland, Oregon, 미국, 97201
- 모집하지 않고 적극적으로
- Oregon Medical Research Center
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Portland, Oregon, 미국, 97210
- 모집하지 않고 적극적으로
- Northwest Dermatology Institute
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Portland, Oregon, 미국, 97210
- 모집하지 않고 적극적으로
- NW Dermatology Institute
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Pennsylvania
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Plymouth Meeting, Pennsylvania, 미국, 19462
- 모집하지 않고 적극적으로
- Dermatology Associates of Plymouth Meeting
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South Carolina
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Charleston, South Carolina, 미국, 29425
- 모집하지 않고 적극적으로
- Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
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Myrtle Beach, South Carolina, 미국, 29588
- 모집하지 않고 적극적으로
- Alliance for Multispecialty Research, LLC
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Texas
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Arlington, Texas, 미국, 76011
- 모집하지 않고 적극적으로
- Arlington Research Center
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Bellaire, Texas, 미국, 77401
- 아직 모집하지 않음
- The University of Texas Health Science Center at Houston
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Dallas, Texas, 미국, 75230
- 모집하지 않고 적극적으로
- Dermatology Treatment and Research Center
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Houston, Texas, 미국, 77004
- 모병
- Center for Clinical Studies
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San Antonio, Texas, 미국, 78218
- 모병
- Texas Dermatology and Laser Specialists
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Webster, Texas, 미국, 77598
- 모병
- Center for Clinical Studies - Clear Lake
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Utah
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Layton, Utah, 미국, 84041
- 모집하지 않고 적극적으로
- AMR Clinical
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Murray, Utah, 미국, 84107
- 모집하지 않고 적극적으로
- University of Utah
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Washington
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Spokane, Washington, 미국, 99202
- 모집하지 않고 적극적으로
- Dermatology Specialists of Spokane
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Spokane, Washington, 미국, 99202
- 모집하지 않고 적극적으로
- Principle Research Solutions
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Madrid, 스페인, 28006
- 모집하지 않고 적극적으로
- Grupo Pedro Jaén
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Madrid, 스페인, 28006
- 모집하지 않고 적극적으로
- Resonancia Magnetica Nuestra Senora del Rosario
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Zaragoza, 스페인, 50009
- 모집하지 않고 적극적으로
- Hospital Universitario Miguel Servet
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A Coruña [LA Coruña]
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Santiago de Compostela, A Coruña [LA Coruña], 스페인, 15706
- 모집하지 않고 적극적으로
- CHUS - Hospital Clinico Universitario
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Andalusia
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Córdoba, Andalusia, 스페인, 14001
- 모집하지 않고 적극적으로
- AUDIKA
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Córdoba, Andalusia, 스페인, 14004
- 모집하지 않고 적극적으로
- Hospital Universitario Reina Sofia
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London, 영국, SE1 7EH
- 모집하지 않고 적극적으로
- Guy's & St Thomas' NHS Foundation Trust
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Brighton AND HOVE
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East Sussex, Brighton AND HOVE, 영국, BN2 1ES
- 모집하지 않고 적극적으로
- University Hospitals Sussex NHS Foundation Trust
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Dundee CITY
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Dundee, Dundee CITY, 영국, DD1 9SY
- 모집하지 않고 적극적으로
- Ninewells Hospital and Medical School
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England
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London, England, 영국, SW10 9NH
- 모집하지 않고 적극적으로
- Chelsea and Westminster Hospital NHS Foundation Trust
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London, CITY of
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London, London, CITY of, 영국, SE1 9RT
- 모집하지 않고 적극적으로
- Guy's & St Thomas' NHS Foundation Trust
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WEST Sussex
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Worthing, WEST Sussex, 영국, BN11 2DH
- 모집하지 않고 적극적으로
- University Hospitals Sussex NHS Foundation Trust
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Osaka, 일본, 545-8586
- 모집하지 않고 적극적으로
- Osaka Metropolitan University Hospital
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Fukuoka
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Kurume, Fukuoka, 일본, 830-0011
- 모집하지 않고 적극적으로
- Kurume University Hospital
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Miyagi
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Sendai, Miyagi, 일본, 980-8574
- 모집하지 않고 적극적으로
- Tohoku University Hospital
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Niigata
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Niigata, Niigata, 일본, 951-8520
- 모집하지 않고 적극적으로
- Niigata University Medical & Dental Hospital
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Shizuoka
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Hamamatsu, Shizuoka, 일본, 431-3192
- 모병
- Hamamatsu University Hospital
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Tokyo
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Koto-ku, Tokyo, 일본, 136-0075
- 모병
- Juntendo Tokyo Koto Geriatric Medical Center
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Mitaka, Tokyo, 일본, 181-8611
- 모병
- Kyorin University Hospital
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Shinjuku-ku, Tokyo, 일본, 160-0023
- 모병
- Tokyo Medical University Hospital
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Beijing, 중국, 100050
- 모집하지 않고 적극적으로
- Beijing Friendship hospital, Capital Medical University
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Beijing, 중국, 100730
- 모집하지 않고 적극적으로
- Beijing Tongren Hospital affiliated to Capital Medical University
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Nanjing, 중국, 210029
- 모집하지 않고 적극적으로
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
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Shanghai, 중국, 200062
- 모병
- Shanghai Children's Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100029
- 모집하지 않고 적극적으로
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, 중국, 100044
- 모집하지 않고 적극적으로
- Peking University People's Hospital
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Beijing, Beijing Municipality, 중국, 100192
- 모집하지 않고 적극적으로
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, 중국, 100032
- 모집하지 않고 적극적으로
- Beijing Children's hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, 중국, 400010
- 모집하지 않고 적극적으로
- The Second Affiliated Hospital Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, 중국, 510120
- 모집하지 않고 적극적으로
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, 중국, 510140
- 모집하지 않고 적극적으로
- The First Affiliated Hospital of Guangzhou Medical University
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Hunan
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Changsha, Hunan, 중국, 410008
- 모집하지 않고 적극적으로
- Xiangya Hospital Central South University
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Jiangxi
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Nanchang, Jiangxi, 중국
- 모집하지 않고 적극적으로
- Jiangxi Provincial Children's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200040
- 모집하지 않고 적극적으로
- Huashan Hospital, Fudan University
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Sichuan
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Chengdu, Sichuan, 중국, 610017
- 모집하지 않고 적극적으로
- Chengdu second people's hospital
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Yunnan
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Kunming, Yunnan, 중국, 650032
- 모집하지 않고 적극적으로
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310009
- 모병
- Hangzhou Third Hospital
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Hangzhou, Zhejiang, 중국, 310016
- 모집하지 않고 적극적으로
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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Pardubice, 체코, 53002
- 모집하지 않고 적극적으로
- Pratia Czech s.r.o.
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Plzeň Region
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Pilsen, Plzeň Region, 체코, 301 00
- 모집하지 않고 적극적으로
- Fakultni Nemocnice Plzen
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Praha 6
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Prague, Praha 6, 체코, 160 00
- 모집하지 않고 적극적으로
- Kozni ambulance Fialova s.r.o
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-
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Québec, 캐나다, G1V 3V9
- 모집하지 않고 적극적으로
- Centre de Recherche Saint-Louis
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Québec, 캐나다, G1V 4X7
- 모집하지 않고 적극적으로
- Centre de Recherche Dermatologique du Quebec metropolitain
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Québec, 캐나다, G1W 4R4
- 모집하지 않고 적극적으로
- Centre de Recherche Saint-Louis inc.
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Alberta
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Calgary, Alberta, 캐나다, T2J 7E1
- 모집하지 않고 적극적으로
- Dermatology Research Institute
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Red Deer, Alberta, 캐나다, T4P 1K4
- 모집하지 않고 적극적으로
- CaRe Clinic
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3M 3Z4
- 모집하지 않고 적극적으로
- Wiseman Dermatology Research Inc.
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Ontario
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Barrie, Ontario, 캐나다, L4M 7G1
- 모집하지 않고 적극적으로
- SimcoDerm Medical and Surgical Dermatology Center
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Guelph, Ontario, 캐나다, N1L 0B7
- 모집하지 않고 적극적으로
- Guelph Dermatology Research
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London, Ontario, 캐나다, N6H 5L5
- 모집하지 않고 적극적으로
- DermEffects
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Markham, Ontario, 캐나다, L3P 1X3
- 모집하지 않고 적극적으로
- Lynderm Research Inc.
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Newmarket, Ontario, 캐나다, L3Y 5G8
- 모집하지 않고 적극적으로
- Ryan Clinical Research Inc.
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Oakville, Ontario, 캐나다, L6J 7W5
- 모집하지 않고 적극적으로
- The Centre for Clinical Trials
-
Ottawa, Ontario, 캐나다, K1K 4L2
- 모집하지 않고 적극적으로
- JRB Research Inc.
-
Peterborough, Ontario, 캐나다, K9J 5K2
- 모집하지 않고 적극적으로
- SKiN Centre for Dermatology
-
Toronto, Ontario, 캐나다, M4W 2N4
- 모집하지 않고 적극적으로
- Dermatology on Bloor - Research Toronto
-
-
Quebec
-
Montreal, Quebec, 캐나다, H2X 2V1
- 모집하지 않고 적극적으로
- Innovaderm Research Inc.
-
Montreal, Quebec, 캐나다, H1Y 3L1
- 모집하지 않고 적극적으로
- Centre de Recherche Saint-Louis
-
Sherbrooke, Quebec, 캐나다, J1G 1X9
- 모집하지 않고 적극적으로
- Centre de Recherche Saint-Louis
-
-
-
-
-
Gdansk, 폴란드, 80-546
- 모집하지 않고 적극적으로
- Penta Hospitals Badania Kliniczne sp. z o.o.
-
Ostrowiec Świętokrzyski, 폴란드, 27-400
- 모집하지 않고 적극적으로
- DERMEDIC Iwona Zdybska
-
Warsaw, 폴란드, 00-124
- 모집하지 않고 적극적으로
- NZOZ GynCentrum - Oddział Warszawa
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, 폴란드, 60-324
- 모집하지 않고 적극적으로
- Twoja Przychodnia PCM
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, 폴란드, 30-002
- 모집하지 않고 적극적으로
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-566
- 모집하지 않고 적극적으로
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, 폴란드, 20-607
- 모집하지 않고 적극적으로
- DERMEDIC Iwona Zdybska
-
-
Lubusz Voivodeship
-
Nowa Sól, Lubusz Voivodeship, 폴란드, 67-100
- 모집하지 않고 적극적으로
- Twoja Przychodnia NCM
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, 폴란드, 00-716
- 모집하지 않고 적극적으로
- Klinika Osipowicz & Turkowski
-
Warsaw, Masovian Voivodeship, 폴란드, 01-018
- 모집하지 않고 적극적으로
- Dr Sękowska Leczenie Bólu
-
Warsaw, Masovian Voivodeship, 폴란드, 02-962
- 모집하지 않고 적극적으로
- Royalderm Agnieszka Nawrocka
-
-
Silesian Voivodeship
-
Katowice, Silesian Voivodeship, 폴란드, 40-611
- 모집하지 않고 적극적으로
- Centrum Medyczne Angelius Provita
-
Sosnowiec, Silesian Voivodeship, 폴란드, 41-200
- 모집하지 않고 적극적으로
- Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
-
-
West Pomeranian Voivodeship
-
Szczecin, West Pomeranian Voivodeship, 폴란드, 71-500
- 모집하지 않고 적극적으로
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
-
-
-
-
San Juan, 푸에르토 리코, 00917
- 모집하지 않고 적극적으로
- GCM Medical Group, PSC - Hato Rey Site
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Age:
-
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:
-
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:
-
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.
-
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.
-
Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
-
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.
-
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
Capsule (to match Ritlecitinib 100 mg) |
|
간섭 없음: 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. |
|
|
실험적: 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
다른 이름들:
|
|
실험적: 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
다른 이름들:
Capsule (to match Ritlecitinib 50 mg) |
|
간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
기간: 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
기간: 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
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
기간: 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"
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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"
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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"
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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"
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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"
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B7981094
- 2024-519370-40-00 (레지스트리 식별자: CTIS (EU))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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