Uno studio di 2 dosi di ritlecitinib nelle persone di età pari o superiore a 12 anni con alopecia areata (ALLEGRO-100)
Uno studio randomizzato di fase 3, esterno e sintetico controllato con placebo con dose-up per i non responder per studiare la sicurezza e l'efficacia di ritlecitinib 50 mg e 100 mg una volta al giorno in partecipanti per adulti e adolescenti di età pari o superiore a 12 anni con Alopecia Areata
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.
Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.
This study is seeking participants who:
- Are 12 years of age or older (Part 1)
- Are 12 to less than 18 years (Part 2)
- Have a diagnosis of alopecia areata
- Have lost 50% or more of the hair on their scalp
- Do not have any other conditions that causes hair loss
- Are willing to stop all other treatments that they may be taking for alopecia areata
About 550 participants will take part in Part 1 of this study. About 80 participants will take part in Part 2 of this study.
In Part 1, participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.
The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.
In Part 2, all eligible participants will receive ritlecitinib 100 mg taken by mouth once daily. The data from this part of the study will be combined with the data from Part 1 of the study to help to see if the 100 mg dose of ritlecitinib is safe and effective in adolescent patients with alopecia areata.
People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:
- alopecia areata assessment,
- physical examinations,
- hearing tests,
- blood tests,
- x-ray,
- ECG (electrocardiogram),
- photographs of the scalp and eyes (Part 1 only). Participants will also be asked to complete questionnaires about their alopecia areata.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Accesso esteso
Contatti e Sedi
Contatto studio
- Nome: Pfizer CT.gov Call Center
- Numero di telefono: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Luoghi di studio
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Québec, Canada, G1V 3V9
- Attivo, non reclutante
- Centre de Recherche Saint-Louis
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Québec, Canada, G1V 4X7
- Attivo, non reclutante
- Centre de Recherche Dermatologique du Quebec metropolitain
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Québec, Canada, G1W 4R4
- Attivo, non reclutante
- Centre de Recherche Saint-Louis inc.
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Alberta
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Calgary, Alberta, Canada, T2J 7E1
- Attivo, non reclutante
- Dermatology Research Institute
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Red Deer, Alberta, Canada, T4P 1K4
- Attivo, non reclutante
- CaRe Clinic
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Attivo, non reclutante
- Wiseman Dermatology Research Inc.
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Attivo, non reclutante
- SimcoDerm Medical and Surgical Dermatology Center
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Guelph, Ontario, Canada, N1L 0B7
- Attivo, non reclutante
- Guelph Dermatology Research
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London, Ontario, Canada, N6H 5L5
- Attivo, non reclutante
- DermEffects
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Markham, Ontario, Canada, L3P 1X3
- Attivo, non reclutante
- Lynderm Research Inc.
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Newmarket, Ontario, Canada, L3Y 5G8
- Attivo, non reclutante
- Ryan Clinical Research Inc.
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Oakville, Ontario, Canada, L6J 7W5
- Attivo, non reclutante
- The Centre for Clinical Trials
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Ottawa, Ontario, Canada, K1K 4L2
- Attivo, non reclutante
- JRB Research Inc.
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Peterborough, Ontario, Canada, K9J 5K2
- Attivo, non reclutante
- SKiN Centre for Dermatology
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Toronto, Ontario, Canada, M4W 2N4
- Attivo, non reclutante
- Dermatology on Bloor - Research Toronto
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Attivo, non reclutante
- Innovaderm Research Inc.
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Montreal, Quebec, Canada, H1Y 3L1
- Attivo, non reclutante
- Centre de Recherche Saint-Louis
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Sherbrooke, Quebec, Canada, J1G 1X9
- Attivo, non reclutante
- Centre de Recherche Saint-Louis
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Pardubice, Cechia, 53002
- Attivo, non reclutante
- Pratia Czech s.r.o.
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Plzeň Region
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Pilsen, Plzeň Region, Cechia, 301 00
- Attivo, non reclutante
- Fakultni Nemocnice Plzen
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Praha 6
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Prague, Praha 6, Cechia, 160 00
- Attivo, non reclutante
- Kozni ambulance Fialova s.r.o
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Beijing, Cina, 100050
- Attivo, non reclutante
- Beijing Friendship hospital, Capital Medical University
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Beijing, Cina, 100730
- Attivo, non reclutante
- Beijing Tongren Hospital affiliated to Capital Medical University
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Nanjing, Cina, 210029
- Attivo, non reclutante
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
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Shanghai, Cina, 200062
- Reclutamento
- Shanghai Children's Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100029
- Attivo, non reclutante
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, Cina, 100044
- Attivo, non reclutante
- Peking University People's Hospital
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Beijing, Beijing Municipality, Cina, 100192
- Attivo, non reclutante
- China-Japan Friendship Hospital
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Beijing, Beijing Municipality, Cina, 100032
- Attivo, non reclutante
- Beijing Children's hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Cina, 400010
- Attivo, non reclutante
- The Second Affiliated Hospital Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Cina, 510120
- Attivo, non reclutante
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, Cina, 510140
- Attivo, non reclutante
- The First Affiliated Hospital of Guangzhou Medical University
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Hunan
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Changsha, Hunan, Cina, 410008
- Attivo, non reclutante
- Xiangya Hospital Central South University
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Jiangxi
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Nanchang, Jiangxi, Cina
- Attivo, non reclutante
- Jiangxi Provincial Children's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200040
- Attivo, non reclutante
- Huashan Hospital, Fudan University
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Sichuan
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Chengdu, Sichuan, Cina, 610017
- Attivo, non reclutante
- Chengdu second people's hospital
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Yunnan
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Kunming, Yunnan, Cina, 650032
- Attivo, non reclutante
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310009
- Reclutamento
- Hangzhou Third Hospital
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Hangzhou, Zhejiang, Cina, 310016
- Attivo, non reclutante
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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Seoul, Corea del Sud, 07061
- Reclutamento
- Seoul Metropolitan Government Seoul National University Boramae Medical Center Laboratory
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Chungcheongnam-do [chungnam]
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Cheonan-si, Chungcheongnam-do [chungnam], Corea del Sud, 31116
- Reclutamento
- Dankook University Hospital
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Jeonrabugdo
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Jeonju, Jeonrabugdo, Corea del Sud, 54907
- Reclutamento
- Jeonbuk National University Hospital
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, Corea del Sud, 13620
- Attivo, non reclutante
- Seoul National University Bundang Hospital
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Pusan-kwangyǒkshi
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Busan, Pusan-kwangyǒkshi, Corea del Sud, 49241
- Reclutamento
- Pusan National University Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sud, 03080
- Attivo, non reclutante
- Seoul National University Hospital
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sud, 05030
- Reclutamento
- Konkuk University Medical Center
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sud, 03312
- Attivo, non reclutante
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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Seoul, Seoul-teukbyeolsi [seoul], Corea del Sud, 05278
- Attivo, non reclutante
- Kyung Hee University Hospital at Gangdong
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Taegu-kwangyǒkshi
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Daegu, Taegu-kwangyǒkshi, Corea del Sud, 41944
- Attivo, non reclutante
- Kyungpook National University Hospital
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Osaka, Giappone, 545-8586
- Attivo, non reclutante
- Osaka Metropolitan University Hospital
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Fukuoka
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Kurume, Fukuoka, Giappone, 830-0011
- Attivo, non reclutante
- Kurume University Hospital
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Miyagi
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Sendai, Miyagi, Giappone, 980-8574
- Attivo, non reclutante
- Tohoku University Hospital
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Niigata
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Niigata, Niigata, Giappone, 951-8520
- Attivo, non reclutante
- Niigata University Medical & Dental Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Giappone, 431-3192
- Reclutamento
- Hamamatsu University Hospital
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Tokyo
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Koto-ku, Tokyo, Giappone, 136-0075
- Reclutamento
- Juntendo Tokyo Koto Geriatric Medical Center
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Mitaka, Tokyo, Giappone, 181-8611
- Reclutamento
- Kyorin University Hospital
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Shinjuku-ku, Tokyo, Giappone, 160-0023
- Reclutamento
- Tokyo Medical University Hospital
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Gdansk, Polonia, 80-546
- Attivo, non reclutante
- Penta Hospitals Badania Kliniczne sp. z o.o.
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Ostrowiec Świętokrzyski, Polonia, 27-400
- Attivo, non reclutante
- DERMEDIC Iwona Zdybska
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Warsaw, Polonia, 00-124
- Attivo, non reclutante
- NZOZ GynCentrum - Oddział Warszawa
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia, 60-324
- Attivo, non reclutante
- Twoja Przychodnia PCM
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-002
- Attivo, non reclutante
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polonia, 50-566
- Attivo, non reclutante
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 20-607
- Attivo, non reclutante
- DERMEDIC Iwona Zdybska
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, Polonia, 67-100
- Attivo, non reclutante
- Twoja Przychodnia NCM
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 00-716
- Attivo, non reclutante
- Klinika Osipowicz & Turkowski
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Warsaw, Masovian Voivodeship, Polonia, 01-018
- Attivo, non reclutante
- Dr Sękowska Leczenie Bólu
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Warsaw, Masovian Voivodeship, Polonia, 02-962
- Attivo, non reclutante
- Royalderm Agnieszka Nawrocka
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polonia, 40-611
- Attivo, non reclutante
- Centrum Medyczne Angelius Provita
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Sosnowiec, Silesian Voivodeship, Polonia, 41-200
- Attivo, non reclutante
- Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polonia, 71-500
- Attivo, non reclutante
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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San Juan, Porto Rico, 00917
- Attivo, non reclutante
- GCM Medical Group, PSC - Hato Rey Site
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London, Regno Unito, SE1 7EH
- Attivo, non reclutante
- Guy's & St Thomas' NHS Foundation Trust
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Brighton AND HOVE
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East Sussex, Brighton AND HOVE, Regno Unito, BN2 1ES
- Attivo, non reclutante
- University Hospitals Sussex NHS Foundation Trust
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Dundee CITY
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Dundee, Dundee CITY, Regno Unito, DD1 9SY
- Attivo, non reclutante
- Ninewells Hospital and Medical School
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England
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London, England, Regno Unito, SW10 9NH
- Attivo, non reclutante
- Chelsea and Westminster Hospital NHS Foundation Trust
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London, CITY of
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London, London, CITY of, Regno Unito, SE1 9RT
- Attivo, non reclutante
- Guy's & St Thomas' NHS Foundation Trust
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WEST Sussex
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Worthing, WEST Sussex, Regno Unito, BN11 2DH
- Attivo, non reclutante
- University Hospitals Sussex NHS Foundation Trust
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Madrid, Spagna, 28006
- Attivo, non reclutante
- Grupo Pedro Jaén
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Madrid, Spagna, 28006
- Attivo, non reclutante
- Resonancia Magnetica Nuestra Senora del Rosario
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Zaragoza, Spagna, 50009
- Attivo, non reclutante
- Hospital Universitario Miguel Servet
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A Coruña [LA Coruña]
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Santiago de Compostela, A Coruña [LA Coruña], Spagna, 15706
- Attivo, non reclutante
- CHUS - Hospital Clinico Universitario
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Andalusia
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Córdoba, Andalusia, Spagna, 14001
- Attivo, non reclutante
- AUDIKA
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Córdoba, Andalusia, Spagna, 14004
- Attivo, non reclutante
- Hospital Universitario Reina Sofia
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- Reclutamento
- University of Alabama at Birmingham
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Birmingham, Alabama, Stati Uniti, 35233
- Reclutamento
- The Kirklin Clinic of UAB Hospital (Radiology)
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Birmingham, Alabama, Stati Uniti, 35233
- Reclutamento
- University of Alabama at Birmingham Faculty Office Towers (Regulatory)
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Arkansas
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Hot Springs, Arkansas, Stati Uniti, 71913
- Attivo, non reclutante
- Burke Pharmaceutical Research
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California
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Brea, California, Stati Uniti, 92821
- Reclutamento
- Doc1 Healthcare Systems
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Encinitas, California, Stati Uniti, 92024
- Attivo, non reclutante
- California Dermatology & Clinical Research Institute
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Huntington Beach, California, Stati Uniti, 92647
- Attivo, non reclutante
- Marvel Clinical Research
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Irvine, California, Stati Uniti, 92617
- Reclutamento
- University of California - Irvine
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Irvine, California, Stati Uniti, 92697
- Reclutamento
- Gavin Herbert Eye Institute
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Santa Ana, California, Stati Uniti, 92701
- Attivo, non reclutante
- Southern California Clinical Research
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Connecticut
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Fairfield, Connecticut, Stati Uniti, 06824
- Reclutamento
- Brett King MD, LLC
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Florida
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Fort Myers, Florida, Stati Uniti, 33912
- Attivo, non reclutante
- Alliance for Multispecialty Research, LLC
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Fort Myers, Florida, Stati Uniti, 33912
- Attivo, non reclutante
- Robert B. Pritt, DO, PA
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Miami, Florida, Stati Uniti, 33173
- Reclutamento
- Skin Research of South Florida
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Miami, Florida, Stati Uniti, 33156
- Reclutamento
- Pediatric Skin Research
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Tampa, Florida, Stati Uniti, 33613
- Attivo, non reclutante
- ForCare Clinical Research
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Tampa, Florida, Stati Uniti, 33615
- Attivo, non reclutante
- Olympian Clinical Research - Tampa - Memorial Highway
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Illinois
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Chicago, Illinois, Stati Uniti, 60625
- Reclutamento
- Endeavor Health Audiology -CHICAGO
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Lake Bluff, Illinois, Stati Uniti, 60044
- Reclutamento
- Endeavor Health Audiology -LAKE BLUFF
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Northbrook, Illinois, Stati Uniti, 60062
- Reclutamento
- Endeavor Health Audiology-NORTHBROOK
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Skokie, Illinois, Stati Uniti, 60077
- Reclutamento
- Endeavor Health
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Skokie, Illinois, Stati Uniti, 60076
- Reclutamento
- Endeavor Health Audiology-SKOKIE
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Skokie, Illinois, Stati Uniti, 60077
- Reclutamento
- Endeavor Health Imaging & Radiology Serviccs - Old Orchard
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Skokie, Illinois, Stati Uniti, 60077
- Reclutamento
- Endeavor Health Lab Services - Old Orchard
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46250
- Reclutamento
- Dawes Fretzin Clinical Research Group, LLC
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242
- Reclutamento
- University of Iowa
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Maryland
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Baltimore, Maryland, Stati Uniti, 21218
- Reclutamento
- Johns Hopkins University
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Glenn Dale, Maryland, Stati Uniti, 20769
- Attivo, non reclutante
- Callender Center for Clinical Research
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Rockville, Maryland, Stati Uniti, 20850
- Reclutamento
- Dermatology and Skin Cancer Specialists, LLC
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Attivo, non reclutante
- Massachusetts General Hospital
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Boston, Massachusetts, Stati Uniti, 02111
- Attivo, non reclutante
- Tufts Medical Center
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Boston, Massachusetts, Stati Uniti, 02114
- Attivo, non reclutante
- The General Hospital Corporation d/b/a Massachusetts General Hospital
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Michigan
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Troy, Michigan, Stati Uniti, 48084
- Attivo, non reclutante
- Revival Research Institute, LLC
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- Reclutamento
- University of Minnesota Health Clinical Research Unit (M Health CRU)
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Minneapolis, Minnesota, Stati Uniti, 55454
- Reclutamento
- University of Minnesota Clinics and Surgery Center Department of Radiology
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Minneapolis, Minnesota, Stati Uniti, 55455
- Reclutamento
- University of Minnesota Clinics and Surgery Center Department of Audiology
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Minneapolis, Minnesota, Stati Uniti, 55455
- Reclutamento
- University of Minnesota Clinics and Surgery Center Department of Radiology
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New York
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New York, New York, Stati Uniti, 10029
- Reclutamento
- Icahn School of Medicine at Mount Sinai
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27516
- Attivo, non reclutante
- UNC Dermatology and Skin Cancer Center
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Chapel Hill, North Carolina, Stati Uniti, 27599
- Attivo, non reclutante
- Clinical & Translational Research Center (CTRC)
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Charlotte, North Carolina, Stati Uniti, 28211
- Attivo, non reclutante
- DJL Clinical Research, PLLC
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Ohio
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Bexley, Ohio, Stati Uniti, 43209
- Reclutamento
- Bexley Dermatology Research
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Canton, Ohio, Stati Uniti, 44718
- Attivo, non reclutante
- Apex Clinical Research Center - Canton
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Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74136
- Reclutamento
- Vital Prospects Clinical Research Institute, PC
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Oregon
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Portland, Oregon, Stati Uniti, 97201
- Attivo, non reclutante
- Oregon Medical Research Center
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Portland, Oregon, Stati Uniti, 97210
- Attivo, non reclutante
- Northwest Dermatology Institute
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Portland, Oregon, Stati Uniti, 97210
- Attivo, non reclutante
- NW Dermatology Institute
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Pennsylvania
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Plymouth Meeting, Pennsylvania, Stati Uniti, 19462
- Attivo, non reclutante
- Dermatology Associates of Plymouth Meeting
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Attivo, non reclutante
- Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
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Myrtle Beach, South Carolina, Stati Uniti, 29588
- Attivo, non reclutante
- Alliance for Multispecialty Research, LLC
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Texas
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Arlington, Texas, Stati Uniti, 76011
- Attivo, non reclutante
- Arlington Research Center
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Bellaire, Texas, Stati Uniti, 77401
- Non ancora reclutamento
- The University of Texas Health Science Center at Houston
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Dallas, Texas, Stati Uniti, 75230
- Attivo, non reclutante
- Dermatology Treatment and Research Center
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Houston, Texas, Stati Uniti, 77004
- Reclutamento
- Center for Clinical Studies
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San Antonio, Texas, Stati Uniti, 78218
- Reclutamento
- Texas Dermatology and Laser Specialists
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Webster, Texas, Stati Uniti, 77598
- Reclutamento
- Center for Clinical Studies - Clear Lake
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Utah
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Layton, Utah, Stati Uniti, 84041
- Attivo, non reclutante
- AMR Clinical
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Murray, Utah, Stati Uniti, 84107
- Attivo, non reclutante
- University of Utah
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Washington
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Spokane, Washington, Stati Uniti, 99202
- Attivo, non reclutante
- Dermatology Specialists of Spokane
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Spokane, Washington, Stati Uniti, 99202
- Attivo, non reclutante
- Principle Research Solutions
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Kaohsiung City, Taiwan, 80756
- Attivo, non reclutante
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taipei, Taiwan, 11217
- Attivo, non reclutante
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 333
- Attivo, non reclutante
- Chang Gung Medical Foundation-Linkou Branch
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Kaohsiung
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Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
- Attivo, non reclutante
- Chang Gung Memorial Hospital at Kaohsiung
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
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History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
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Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
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General Infection History:
- Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.
- Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves.
- Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
-
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
Capsule (to match Ritlecitinib 100 mg) |
|
Nessun intervento: 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. |
|
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Capsule (to match Ritlecitinib 50 mg) |
|
Nessun intervento: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Lasso di tempo: 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"
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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"
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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"
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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"
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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"
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B7981094
- 2024-519370-40-00 (Identificatore di registro: CTIS (EU))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .