Badanie 2 dawek ritlecytynibu u osób w wieku 12 lat i starszych z łysieniem areata (ALLEGRO-100)
Faza 3, zewnętrzne i syntetyczne kontrolowane placebo randomizowane badanie z dawką dla osób niereagujących w celu zbadania bezpieczeństwa i skuteczności ritlecytynibu 50 mg i 100 mg dziennie u dorosłych i nastolatków w wieku 12 lat i starszych z łysą Areatą
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 3
Rozszerzony dostęp
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Pfizer CT.gov Call Center
- Numer telefonu: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Lokalizacje studiów
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Beijing, Chiny, 100050
- Aktywny, nie rekrutujący
- Beijing Friendship hospital, Capital Medical University
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Beijing, Chiny, 100730
- Aktywny, nie rekrutujący
- Beijing Tongren Hospital affiliated to Capital Medical University
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Nanjing, Chiny, 210029
- Aktywny, nie rekrutujący
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
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Shanghai, Chiny, 200062
- Rekrutacyjny
- Shanghai Children's Hospital
-
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100029
- Aktywny, nie rekrutujący
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, Chiny, 100044
- Aktywny, nie rekrutujący
- Peking University People's Hospital
-
Beijing, Beijing Municipality, Chiny, 100192
- Aktywny, nie rekrutujący
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, Chiny, 100032
- Aktywny, nie rekrutujący
- Beijing Children's hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Chiny, 400010
- Aktywny, nie rekrutujący
- The Second Affiliated Hospital Chongqing Medical University
-
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Guangdong
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Guangzhou, Guangdong, Chiny, 510120
- Aktywny, nie rekrutujący
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, Chiny, 510140
- Aktywny, nie rekrutujący
- The First Affiliated Hospital of Guangzhou Medical University
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Hunan
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Changsha, Hunan, Chiny, 410008
- Aktywny, nie rekrutujący
- Xiangya Hospital Central South University
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Jiangxi
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Nanchang, Jiangxi, Chiny
- Aktywny, nie rekrutujący
- Jiangxi Provincial Children's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200040
- Aktywny, nie rekrutujący
- Huashan Hospital, Fudan University
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Sichuan
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Chengdu, Sichuan, Chiny, 610017
- Aktywny, nie rekrutujący
- Chengdu second people's hospital
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Yunnan
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Kunming, Yunnan, Chiny, 650032
- Aktywny, nie rekrutujący
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, Chiny, 310009
- Rekrutacyjny
- Hangzhou Third Hospital
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Hangzhou, Zhejiang, Chiny, 310016
- Aktywny, nie rekrutujący
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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-
-
-
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Pardubice, Czechy, 53002
- Aktywny, nie rekrutujący
- Pratia Czech s.r.o.
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Plzeň Region
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Pilsen, Plzeň Region, Czechy, 301 00
- Aktywny, nie rekrutujący
- Fakultni Nemocnice Plzen
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Praha 6
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Prague, Praha 6, Czechy, 160 00
- Aktywny, nie rekrutujący
- Kozni ambulance Fialova s.r.o
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-
-
-
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Madrid, Hiszpania, 28006
- Aktywny, nie rekrutujący
- Grupo Pedro Jaén
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Madrid, Hiszpania, 28006
- Aktywny, nie rekrutujący
- Resonancia Magnetica Nuestra Senora del Rosario
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Zaragoza, Hiszpania, 50009
- Aktywny, nie rekrutujący
- Hospital Universitario Miguel Servet
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A Coruña [LA Coruña]
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Santiago de Compostela, A Coruña [LA Coruña], Hiszpania, 15706
- Aktywny, nie rekrutujący
- CHUS - Hospital Clinico Universitario
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Andalusia
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Córdoba, Andalusia, Hiszpania, 14001
- Aktywny, nie rekrutujący
- AUDIKA
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Córdoba, Andalusia, Hiszpania, 14004
- Aktywny, nie rekrutujący
- Hospital Universitario Reina Sofia
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-
-
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Osaka, Japonia, 545-8586
- Aktywny, nie rekrutujący
- Osaka Metropolitan University Hospital
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Fukuoka
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Kurume, Fukuoka, Japonia, 830-0011
- Aktywny, nie rekrutujący
- Kurume University Hospital
-
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Miyagi
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Sendai, Miyagi, Japonia, 980-8574
- Aktywny, nie rekrutujący
- Tohoku University Hospital
-
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Niigata
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Niigata, Niigata, Japonia, 951-8520
- Aktywny, nie rekrutujący
- Niigata University Medical & Dental Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japonia, 431-3192
- Rekrutacyjny
- Hamamatsu University Hospital
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Tokyo
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Koto-ku, Tokyo, Japonia, 136-0075
- Rekrutacyjny
- Juntendo Tokyo Koto Geriatric Medical Center
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Mitaka, Tokyo, Japonia, 181-8611
- Rekrutacyjny
- Kyorin University Hospital
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Shinjuku-ku, Tokyo, Japonia, 160-0023
- Rekrutacyjny
- Tokyo Medical University Hospital
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-
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Québec, Kanada, G1V 3V9
- Aktywny, nie rekrutujący
- Centre de Recherche Saint-Louis
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Québec, Kanada, G1V 4X7
- Aktywny, nie rekrutujący
- Centre de Recherche Dermatologique du Quebec metropolitain
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Québec, Kanada, G1W 4R4
- Aktywny, nie rekrutujący
- Centre de Recherche Saint-Louis inc.
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Alberta
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Calgary, Alberta, Kanada, T2J 7E1
- Aktywny, nie rekrutujący
- Dermatology Research Institute
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Red Deer, Alberta, Kanada, T4P 1K4
- Aktywny, nie rekrutujący
- CaRe Clinic
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Manitoba
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Winnipeg, Manitoba, Kanada, R3M 3Z4
- Aktywny, nie rekrutujący
- Wiseman Dermatology Research Inc.
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Ontario
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Barrie, Ontario, Kanada, L4M 7G1
- Aktywny, nie rekrutujący
- SimcoDerm Medical and Surgical Dermatology Center
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Guelph, Ontario, Kanada, N1L 0B7
- Aktywny, nie rekrutujący
- Guelph Dermatology Research
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London, Ontario, Kanada, N6H 5L5
- Aktywny, nie rekrutujący
- DermEffects
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Markham, Ontario, Kanada, L3P 1X3
- Aktywny, nie rekrutujący
- Lynderm Research Inc.
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Newmarket, Ontario, Kanada, L3Y 5G8
- Aktywny, nie rekrutujący
- Ryan Clinical Research Inc.
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Oakville, Ontario, Kanada, L6J 7W5
- Aktywny, nie rekrutujący
- The Centre for Clinical Trials
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Ottawa, Ontario, Kanada, K1K 4L2
- Aktywny, nie rekrutujący
- JRB Research Inc.
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Peterborough, Ontario, Kanada, K9J 5K2
- Aktywny, nie rekrutujący
- SKiN Centre for Dermatology
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Toronto, Ontario, Kanada, M4W 2N4
- Aktywny, nie rekrutujący
- Dermatology on Bloor - Research Toronto
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Quebec
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Montreal, Quebec, Kanada, H2X 2V1
- Aktywny, nie rekrutujący
- Innovaderm Research Inc.
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Montreal, Quebec, Kanada, H1Y 3L1
- Aktywny, nie rekrutujący
- Centre de Recherche Saint-Louis
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Sherbrooke, Quebec, Kanada, J1G 1X9
- Aktywny, nie rekrutujący
- Centre de Recherche Saint-Louis
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Seoul, Korea Południowa, 07061
- Rekrutacyjny
- 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], Korea Południowa, 31116
- Rekrutacyjny
- Dankook University Hospital
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Jeonrabugdo
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Jeonju, Jeonrabugdo, Korea Południowa, 54907
- Rekrutacyjny
- Jeonbuk National University Hospital
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, Korea Południowa, 13620
- Aktywny, nie rekrutujący
- Seoul National University Bundang Hospital
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Pusan-kwangyǒkshi
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Busan, Pusan-kwangyǒkshi, Korea Południowa, 49241
- Rekrutacyjny
- Pusan National University Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], Korea Południowa, 03080
- Aktywny, nie rekrutujący
- Seoul National University Hospital
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Seoul, Seoul-teukbyeolsi [seoul], Korea Południowa, 05030
- Rekrutacyjny
- Konkuk University Medical Center
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Seoul, Seoul-teukbyeolsi [seoul], Korea Południowa, 03312
- Aktywny, nie rekrutujący
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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Seoul, Seoul-teukbyeolsi [seoul], Korea Południowa, 05278
- Aktywny, nie rekrutujący
- Kyung Hee University Hospital at Gangdong
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Taegu-kwangyǒkshi
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Daegu, Taegu-kwangyǒkshi, Korea Południowa, 41944
- Aktywny, nie rekrutujący
- Kyungpook National University Hospital
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Gdansk, Polska, 80-546
- Aktywny, nie rekrutujący
- Penta Hospitals Badania Kliniczne sp. z o.o.
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Ostrowiec Świętokrzyski, Polska, 27-400
- Aktywny, nie rekrutujący
- DERMEDIC Iwona Zdybska
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Warsaw, Polska, 00-124
- Aktywny, nie rekrutujący
- NZOZ GynCentrum - Oddział Warszawa
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polska, 60-324
- Aktywny, nie rekrutujący
- Twoja Przychodnia PCM
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polska, 30-002
- Aktywny, nie rekrutujący
- 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, Polska, 50-566
- Aktywny, nie rekrutujący
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polska, 20-607
- Aktywny, nie rekrutujący
- DERMEDIC Iwona Zdybska
-
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, Polska, 67-100
- Aktywny, nie rekrutujący
- Twoja Przychodnia NCM
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polska, 00-716
- Aktywny, nie rekrutujący
- Klinika Osipowicz & Turkowski
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Warsaw, Masovian Voivodeship, Polska, 01-018
- Aktywny, nie rekrutujący
- Dr Sękowska Leczenie Bólu
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Warsaw, Masovian Voivodeship, Polska, 02-962
- Aktywny, nie rekrutujący
- Royalderm Agnieszka Nawrocka
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polska, 40-611
- Aktywny, nie rekrutujący
- Centrum Medyczne Angelius Provita
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Sosnowiec, Silesian Voivodeship, Polska, 41-200
- Aktywny, nie rekrutujący
- 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, Polska, 71-500
- Aktywny, nie rekrutujący
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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San Juan, Portoryko, 00917
- Aktywny, nie rekrutujący
- GCM Medical Group, PSC - Hato Rey Site
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-
-
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35233
- Rekrutacyjny
- University of Alabama at Birmingham
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Birmingham, Alabama, Stany Zjednoczone, 35233
- Rekrutacyjny
- The Kirklin Clinic of UAB Hospital (Radiology)
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Birmingham, Alabama, Stany Zjednoczone, 35233
- Rekrutacyjny
- University of Alabama at Birmingham Faculty Office Towers (Regulatory)
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Arkansas
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Hot Springs, Arkansas, Stany Zjednoczone, 71913
- Aktywny, nie rekrutujący
- Burke Pharmaceutical Research
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California
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Brea, California, Stany Zjednoczone, 92821
- Rekrutacyjny
- Doc1 Healthcare Systems
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Encinitas, California, Stany Zjednoczone, 92024
- Aktywny, nie rekrutujący
- California Dermatology & Clinical Research Institute
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Huntington Beach, California, Stany Zjednoczone, 92647
- Aktywny, nie rekrutujący
- Marvel Clinical Research
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Irvine, California, Stany Zjednoczone, 92617
- Rekrutacyjny
- University of California - Irvine
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Irvine, California, Stany Zjednoczone, 92697
- Rekrutacyjny
- Gavin Herbert Eye Institute
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Santa Ana, California, Stany Zjednoczone, 92701
- Aktywny, nie rekrutujący
- Southern California Clinical Research
-
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Connecticut
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Fairfield, Connecticut, Stany Zjednoczone, 06824
- Rekrutacyjny
- Brett King MD, LLC
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Florida
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Fort Myers, Florida, Stany Zjednoczone, 33912
- Aktywny, nie rekrutujący
- Alliance for Multispecialty Research, LLC
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Fort Myers, Florida, Stany Zjednoczone, 33912
- Aktywny, nie rekrutujący
- Robert B. Pritt, DO, PA
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Miami, Florida, Stany Zjednoczone, 33173
- Rekrutacyjny
- Skin Research of South Florida
-
Miami, Florida, Stany Zjednoczone, 33156
- Rekrutacyjny
- Pediatric Skin Research
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Tampa, Florida, Stany Zjednoczone, 33613
- Aktywny, nie rekrutujący
- ForCare Clinical Research
-
Tampa, Florida, Stany Zjednoczone, 33615
- Aktywny, nie rekrutujący
- Olympian Clinical Research - Tampa - Memorial Highway
-
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60625
- Rekrutacyjny
- Endeavor Health Audiology -CHICAGO
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Lake Bluff, Illinois, Stany Zjednoczone, 60044
- Rekrutacyjny
- Endeavor Health Audiology -LAKE BLUFF
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Northbrook, Illinois, Stany Zjednoczone, 60062
- Rekrutacyjny
- Endeavor Health Audiology-NORTHBROOK
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Skokie, Illinois, Stany Zjednoczone, 60077
- Rekrutacyjny
- Endeavor Health
-
Skokie, Illinois, Stany Zjednoczone, 60076
- Rekrutacyjny
- Endeavor Health Audiology-SKOKIE
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Skokie, Illinois, Stany Zjednoczone, 60077
- Rekrutacyjny
- Endeavor Health Imaging & Radiology Serviccs - Old Orchard
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Skokie, Illinois, Stany Zjednoczone, 60077
- Rekrutacyjny
- Endeavor Health Lab Services - Old Orchard
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Indiana
-
Indianapolis, Indiana, Stany Zjednoczone, 46250
- Rekrutacyjny
- Dawes Fretzin Clinical Research Group, LLC
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Iowa
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Iowa City, Iowa, Stany Zjednoczone, 52242
- Rekrutacyjny
- University of Iowa
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21218
- Rekrutacyjny
- Johns Hopkins University
-
Glenn Dale, Maryland, Stany Zjednoczone, 20769
- Aktywny, nie rekrutujący
- Callender Center for Clinical Research
-
Rockville, Maryland, Stany Zjednoczone, 20850
- Rekrutacyjny
- Dermatology and Skin Cancer Specialists, LLC
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02114
- Aktywny, nie rekrutujący
- Massachusetts General Hospital
-
Boston, Massachusetts, Stany Zjednoczone, 02111
- Aktywny, nie rekrutujący
- Tufts Medical Center
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Aktywny, nie rekrutujący
- The General Hospital Corporation d/b/a Massachusetts General Hospital
-
-
Michigan
-
Troy, Michigan, Stany Zjednoczone, 48084
- Aktywny, nie rekrutujący
- Revival Research Institute, LLC
-
-
Minnesota
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- Rekrutacyjny
- University of Minnesota Health Clinical Research Unit (M Health CRU)
-
Minneapolis, Minnesota, Stany Zjednoczone, 55454
- Rekrutacyjny
- University of Minnesota Clinics and Surgery Center Department of Radiology
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- Rekrutacyjny
- University of Minnesota Clinics and Surgery Center Department of Audiology
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- Rekrutacyjny
- University of Minnesota Clinics and Surgery Center Department of Radiology
-
-
New York
-
New York, New York, Stany Zjednoczone, 10029
- Rekrutacyjny
- Icahn School of Medicine at Mount Sinai
-
-
North Carolina
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27516
- Aktywny, nie rekrutujący
- UNC Dermatology and Skin Cancer Center
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27599
- Aktywny, nie rekrutujący
- Clinical & Translational Research Center (CTRC)
-
Charlotte, North Carolina, Stany Zjednoczone, 28211
- Aktywny, nie rekrutujący
- DJL Clinical Research, PLLC
-
-
Ohio
-
Bexley, Ohio, Stany Zjednoczone, 43209
- Rekrutacyjny
- Bexley Dermatology Research
-
Canton, Ohio, Stany Zjednoczone, 44718
- Aktywny, nie rekrutujący
- Apex Clinical Research Center - Canton
-
-
Oklahoma
-
Tulsa, Oklahoma, Stany Zjednoczone, 74136
- Rekrutacyjny
- Vital Prospects Clinical Research Institute, PC
-
-
Oregon
-
Portland, Oregon, Stany Zjednoczone, 97201
- Aktywny, nie rekrutujący
- Oregon Medical Research Center
-
Portland, Oregon, Stany Zjednoczone, 97210
- Aktywny, nie rekrutujący
- Northwest Dermatology Institute
-
Portland, Oregon, Stany Zjednoczone, 97210
- Aktywny, nie rekrutujący
- NW Dermatology Institute
-
-
Pennsylvania
-
Plymouth Meeting, Pennsylvania, Stany Zjednoczone, 19462
- Aktywny, nie rekrutujący
- Dermatology Associates of Plymouth Meeting
-
-
South Carolina
-
Charleston, South Carolina, Stany Zjednoczone, 29425
- Aktywny, nie rekrutujący
- Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
-
Myrtle Beach, South Carolina, Stany Zjednoczone, 29588
- Aktywny, nie rekrutujący
- Alliance for Multispecialty Research, LLC
-
-
Texas
-
Arlington, Texas, Stany Zjednoczone, 76011
- Aktywny, nie rekrutujący
- Arlington Research Center
-
Bellaire, Texas, Stany Zjednoczone, 77401
- Jeszcze nie rekrutacja
- The University of Texas Health Science Center at Houston
-
Dallas, Texas, Stany Zjednoczone, 75230
- Aktywny, nie rekrutujący
- Dermatology Treatment and Research Center
-
Houston, Texas, Stany Zjednoczone, 77004
- Rekrutacyjny
- Center for Clinical Studies
-
San Antonio, Texas, Stany Zjednoczone, 78218
- Rekrutacyjny
- Texas Dermatology and Laser Specialists
-
Webster, Texas, Stany Zjednoczone, 77598
- Rekrutacyjny
- Center for Clinical Studies - Clear Lake
-
-
Utah
-
Layton, Utah, Stany Zjednoczone, 84041
- Aktywny, nie rekrutujący
- AMR Clinical
-
Murray, Utah, Stany Zjednoczone, 84107
- Aktywny, nie rekrutujący
- University of Utah
-
-
Washington
-
Spokane, Washington, Stany Zjednoczone, 99202
- Aktywny, nie rekrutujący
- Dermatology Specialists of Spokane
-
Spokane, Washington, Stany Zjednoczone, 99202
- Aktywny, nie rekrutujący
- Principle Research Solutions
-
-
-
-
-
Kaohsiung City, Tajwan, 80756
- Aktywny, nie rekrutujący
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taipei, Tajwan, 11217
- Aktywny, nie rekrutujący
- Taipei Veterans General Hospital
-
Taoyuan, Tajwan, 333
- Aktywny, nie rekrutujący
- Chang Gung Medical Foundation-Linkou Branch
-
-
Kaohsiung
-
Kaohsiung Niao Sung Dist, Kaohsiung, Tajwan, 83301
- Aktywny, nie rekrutujący
- Chang Gung Memorial Hospital at Kaohsiung
-
-
-
-
-
London, Zjednoczone Królestwo, SE1 7EH
- Aktywny, nie rekrutujący
- Guy's & St Thomas' NHS Foundation Trust
-
-
Brighton AND HOVE
-
East Sussex, Brighton AND HOVE, Zjednoczone Królestwo, BN2 1ES
- Aktywny, nie rekrutujący
- University Hospitals Sussex NHS Foundation Trust
-
-
Dundee CITY
-
Dundee, Dundee CITY, Zjednoczone Królestwo, DD1 9SY
- Aktywny, nie rekrutujący
- Ninewells Hospital and Medical School
-
-
England
-
London, England, Zjednoczone Królestwo, SW10 9NH
- Aktywny, nie rekrutujący
- Chelsea and Westminster Hospital NHS Foundation Trust
-
-
London, CITY of
-
London, London, CITY of, Zjednoczone Królestwo, SE1 9RT
- Aktywny, nie rekrutujący
- Guy's & St Thomas' NHS Foundation Trust
-
-
WEST Sussex
-
Worthing, WEST Sussex, Zjednoczone Królestwo, BN11 2DH
- Aktywny, nie rekrutujący
- University Hospitals Sussex NHS Foundation Trust
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
Capsule (to match Ritlecitinib 100 mg) |
|
Brak interwencji: 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. |
|
|
Eksperymentalny: 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
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Capsule (to match Ritlecitinib 50 mg) |
|
Brak interwencji: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Ramy czasowe: 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"
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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"
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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"
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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"
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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"
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Pfizer CT.gov Call Center, Pfizer
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- B7981094
- 2024-519370-40-00 (Identyfikator rejestru: CTIS (EU))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .