Une étude pour évaluer le rocatinlimab (AMG 451) chez des sujets adolescents atteints de dermatite atopique (DA) modérée à sévère (ROCKET-ASTRO)
6 août 2026 mis à jour par: Amgen
Une étude de phase 3, randomisée, de 52 semaines, contrôlée par placebo, en double aveugle avec rerandomisation pour évaluer l'efficacité, l'innocuité et la tolérabilité du rocatinlimab (AMG 451) chez des sujets adolescents atteints de dermatite atopique (DA) modérée à sévère ( ROCKET-ASTRO)
Le but de cette étude est d'évaluer l'efficacité et l'innocuité du rocatinlimab en monothérapie et en association chez des sujets adolescents.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
532
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bad Bentheim, Allemagne, 48455
- Fachklinik Bad Bentheim
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Bonn, Allemagne, 53127
- Universitaetsklinikum Bonn
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Darmstadt, Allemagne, 64283
- Rosenpark Research GmbH
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Dresden, Allemagne, 01307
- Universitaetsklinikum Dresden
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Erlangen, Allemagne, 91054
- Universitaetsklinikum Erlangen
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Frankfurt am Main, Allemagne, 60590
- Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
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Leipzig, Allemagne, 04103
- Velocity Clinical Research
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Mainz, Allemagne, 55101
- Johannes Gutenberg Universitaet Mainz
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Brussels, Belgique, 1070
- Hopital Erasme
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Brussels, Belgique, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Belgique, 9000
- Universitair Ziekenhuis Gent
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Liège, Belgique, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Maldegem, Belgique, 9990
- Dermatologie Maldegem
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Rio de Janeiro, Brésil, 20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
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Espírito Santo
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Vitória, Espírito Santo, Brésil, 29055-450
- Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
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Estado de Bahia
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Salvador, Estado de Bahia, Brésil, 41820-020
- Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brésil, 30575-180
- Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brésil, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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São Paulo
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Jaú, São Paulo, Brésil, 17201-130
- Cecip Centro Est Clin Int Paulista
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Ribeirão Preto, São Paulo, Brésil, 14026-020
- Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
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São José do Rio Preto, São Paulo, Brésil, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brésil, 01228-200
- Instituto Pesquisa e Ensino em Saúde Infantil
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São Paulo, São Paulo, Brésil, 05403-002
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Alberta
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Calgary, Alberta, Canada, T3K 6B8
- Rejuvenation Dermatology Laser Calgary North
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Ontario
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Markham, Ontario, Canada, L3P 1X3
- Lynderm Research Inc
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Newmarket, Ontario, Canada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Canada, L2H 1H5
- Allergy Research Canada Incorporated
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Windsor, Ontario, Canada, N8T 1E6
- XLR8 Medical Research, Incorporated
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 2C1
- Skinsense Medical Research
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Osorno, Chili, 5310644
- Centro Dermatologico Dermisur
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Santiago, Chili, 7640881
- Clinica Dermacross SA
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Santiago, Chili, 7580206
- Centro Medico Skinmed Spa
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Santiago, Chili, 8380465
- Fundacion Innovacion Cardiovascular
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Santiago, Chili, 8420383
- Centro Internacional de Estudios Clínicos
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Changsha, Chine, 410007
- Hunan Childrens Hospital
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Shenzhen, Chine, 518038
- Shenzhen Childrens Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Chine, 100020
- Childrens Hospital Capital Institute of Pediatrics
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Beijing, Beijing Municipality, Chine, 100044
- Peking University Peoples Hospital
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Beijing, Beijing Municipality, Chine, 100045
- Beijing Childrens Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Chine, 400014
- Childrens Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Chine, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, Chine, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, Chine, 510080
- The First Affiliated Hospital Sun-Yat Sen University
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Henan
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Nanyang, Henan, Chine, 473002
- Nanyang First Peoples Hospital
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Hubei
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Wuhan, Hubei, Chine, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Wuhan, Hubei, Chine, 430014
- The Central Hospital of Wuhan
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Jiangsu
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Jiangyin, Jiangsu, Chine, 214400
- Jiangyin Hospital of Traditional Chinese Medicine
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Jilin
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Changchun, Jilin, Chine, 130021
- The First Bethune Hospital of Jilin University
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Liaoning
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Dalian, Liaoning, Chine, 116011
- Dalian Women and Childrens Medical Group
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Ningxia
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Yinchuan, Ningxia, Chine, 750003
- General Hospital of Ningxia Medical University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200443
- Shanghai Skin Disease Hospital
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Sichuan
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Chengdu, Sichuan, Chine, 610021
- Chengdu Second Peoples Hospital
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Suining, Sichuan, Chine, 629099
- Suining Central Hospital
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Yunnan
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Kunming, Yunnan, Chine, 650103
- Kunming Childrens Hospital
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310020
- Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
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Ningbo, Zhejiang, Chine, 315010
- Ningbo NO 2 Hospital
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Taizhou, Zhejiang, Chine, 318000
- Taizhou Central Hospital
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Ansansi, Gyeonggido, Corée du Sud, 15355
- Korea University Ansan Hospital
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Corée du Sud, 01830
- Nowon Eulji Medical Center, Eulji University
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Seoul, Corée du Sud, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, Corée du Sud, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, Corée du Sud, 08308
- Korea University Guro Hospital
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Seoul, Corée du Sud, 06973
- Chung-Ang University Hospital
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Seoul, Corée du Sud, 07441
- Hallym University Kangnam Sacred Heart Hospital
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Seoul, Corée du Sud, 04564
- National Medical Center
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Seoul, Corée du Sud, 07804
- Ewha Womans University Seoul Hospital
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Ivanić-Grad, Croatie, 10310
- Special Hospital for Medical Rehabilitation Naftalan
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Osijek, Croatie, 31000
- University Hospital Centre Osijek
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Zagreb, Croatie, 10000
- University Hospital Centre Zagreb
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Zagreb, Croatie, 10000
- Sestre milosrdnice University Hospital Center
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Zagreb, Croatie, 10000
- Children s Hospital Zagreb
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Madrid, Espagne, 28046
- Hospital Universitario La Paz
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Madrid, Espagne, 28007
- Hospital General Universitario Gregorio Marañón
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Catalonia
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Barcelona, Catalonia, Espagne, 08041
- Hospital de La Santa Creu i Sant Pau
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Esplugues de Llobregat, Catalonia, Espagne, 08950
- Hospital Sant Joan de Déu
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Navarre
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Pamplona, Navarre, Espagne, 31008
- Clinica Universidad de Navarra
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Antony, France, 92160
- Hopital Prive d Antony
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Brest, France, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Marseille, France, 13285
- Hôpital Saint-Joseph
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Nantes, France, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Rennes, France, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, France, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Toulouse, France, 31059
- Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
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Athens, Grèce, 11521
- Athens Naval Hospital
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Athens, Grèce, 11527
- Thoracic General Hospital Of Athens Sotiria
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Athens, Grèce, 11527
- Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
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Thessaloniki, Grèce, 54643
- Ippokratio General Hospital of Thessaloniki
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Budapest, Hongrie, 1033
- Clinexpert Kft
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Debrecen, Hongrie, 4032
- Debreceni Egyetem Klinikai Kozpont
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Debrecen, Hongrie, 4031
- Derma-B Egeszsegugyi es Szolgaltato Kft
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Kaposvár, Hongrie, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Bear Sheva, Israël, 8410101
- Soroka Medical Center
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Ramat Gan, Israël, 5262000
- Sheba medical center
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Tel Aviv, Israël, 6423906
- Sourasky Medical Center
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Milan, Italie, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Naples, Italie, 80131
- Azienda Ospedaliera Universitaria Luigi Vanvitelli
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Perugia, Italie, 06129
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
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Torino, Italie, 10126
- Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
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Aichi-ken
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Nagoya, Aichi-ken, Japon, 464-0821
- Central Clinic
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Chiba
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Matsudo-shi, Chiba, Japon, 271-0092
- Miyata Dermatology Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japon, 819-0373
- Matsuo Clinic
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Hokkaido
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Asahikawa-shi, Hokkaido, Japon, 070-8610
- Asahikawa City Hospital
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Obihiro-shi, Hokkaido, Japon, 080-0013
- Takagi Dermatological Clinic
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Hyōgo
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Akashi-shi, Hyōgo, Japon, 674-0068
- Yoshimura Child Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japon, 890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Yokohama, Kanagawa, Japon, 231-8682
- Yokohama City Minato Red Cross Hospital
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Yokohama, Kanagawa, Japon, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japon, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, Japon, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, Japon, 572-0838
- Yoshioka Dermatology Clinic
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Sakai-shi, Osaka, Japon, 593-8324
- Dermatology and Ophthalmology Kume Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japon, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Setagaya-ku, Tokyo, Japon, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, Japon, 141-8625
- NTT Medical Center Tokyo
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Toluca, Mexique, 50090
- Phylasis Clinicas Research Toluca
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Gdansk, Pologne, 80-214
- Uniwersyteckie Centrum Kliniczne
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Gdansk, Pologne, 80-280
- AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
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Katowice, Pologne, 40-611
- Centrum Medyczne Angelius Provita
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Katowice, Pologne, 40-600
- GynCentrum Sp zoo NZOZ Holsamed
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Krakow, Pologne, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Krakow, Pologne, 31-559
- Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
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Lodz, Pologne, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Pologne, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin, Pologne, 20-011
- Clinical Best Solutions Sp zoo Spolka komandytowa
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Sosnowiec, Pologne, 41-200
- Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
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Tarnów, Pologne, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
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Warsaw, Pologne, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Pologne, 02-953
- Klinika Ambroziak Dermatologia
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Warsaw, Pologne, 00-716
- Klinika Osipowicz and Turkowski Sp zoo
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Warsaw, Pologne, 01-817
- High Med Przychodnia Specjalistyczna
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Wroclaw, Pologne, 50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
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San Juan, Porto Rico, 00917
- GCM Medical Group, PSC
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San Juan, Porto Rico, 00909
- Clinical Research of Puerto Rico
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Bucharest, Roumanie, 011216
- Dr Leventer Centre Clinica Dermatologie Bucuresti
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Cluj-Napoca, Roumanie, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Cluj-Napoca, Roumanie, 400105
- Derma Cluj
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Kaohsiung City, Taïwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Taïwan, 10002
- National Taiwan University Hospital
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Taipei, Taïwan, 11217
- Taipei Veterans General Hospital
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Taoyuan, Taïwan, 33305
- Linkou Chang Gung Memorial Hospital
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Bangkok, Thaïlande, 10330
- King Chulalongkorn Memorial Hospital
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Bangkok, Thaïlande, 10700
- Siriraj Hospital
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Chiang Mai, Thaïlande, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Pathum Thani, Thaïlande, 12120
- Thammasat University Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35244
- Cahaba Dermatology and Skin Health Center
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Cullman, Alabama, États-Unis, 35058
- AllerVie Clinical Research- Cullman
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Arizona
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Tucson, Arizona, États-Unis, 85745
- Eclipse Clinical Research
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Arkansas
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North Little Rock, Arkansas, États-Unis, 72117
- Arkansas Research Trials, LLC
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California
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Fremont, California, États-Unis, 94538
- Center for Dermatology Clinical Research Inc
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Fullerton, California, États-Unis, 92831
- Doc1 Healthcare Systems Incorporated
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Inglewood, California, États-Unis, 90301
- Axon Clinical Research
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Laguna Niguel, California, États-Unis, 92677
- Avance Clinical Trials
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Palmdale, California, États-Unis, 93551
- Cura Clinical Research
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Sacramento, California, États-Unis, 95815
- Integrative Skin Science and Research
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Sacramento, California, États-Unis, 95816
- University of California at Davis Medical Center
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San Diego, California, États-Unis, 92123
- Allergy and Asthma Medical Group and Research Center
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San Diego, California, États-Unis, 92123
- University of California at San Diego Rady Childrens Hospital San Diego
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Santa Monica, California, États-Unis, 90404
- Clinical Science Institute
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Sherman Oaks, California, États-Unis, 91403
- Cura Clinical Research Sherman Oaks
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Colorado
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Denver, Colorado, États-Unis, 80209
- Velocity Clinical Research - Denver
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20010
- Childrens National Medical Center
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Florida
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Brandon, Florida, États-Unis, 33511
- Clinical Research of Brandon
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Clearwater, Florida, États-Unis, 33761
- Academic Alliance in Dermatology - Saint Petersburg Office
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Coral Springs, Florida, États-Unis, 33071
- Corazon United States of America, LLC doing business as Life Clinical Trials
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Delray Beach, Florida, États-Unis, 33484
- Palm Beach Dermatology Group
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Hialeah, Florida, États-Unis, 33012
- Direct Helpers Research Center
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Margate, Florida, États-Unis, 33063
- Glick Skin Institute
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Miami, Florida, États-Unis, 33155
- Miami Clinical Research
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Miami, Florida, États-Unis, 33176
- ara Professionals Limited Liability Corporation
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Miami Lakes, Florida, États-Unis, 33014
- Savin Medical Group LLC
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Miami Lakes, Florida, États-Unis, 33016
- Angels Clinical Research Institute
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Miami Lakes, Florida, États-Unis, 33014
- Deluxe Health Care LLC
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Orange City, Florida, États-Unis, 32763
- Optimal Research Sites, LLC
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Orlando, Florida, États-Unis, 32819
- Clinical Research Investments
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Orlando, Florida, États-Unis, 32819
- Clinical Associates of Orlando Limited Liability Company
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Tampa, Florida, États-Unis, 33612
- University of South Florida
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Georgia
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Columbus, Georgia, États-Unis, 31904
- Centricity Research Columbus
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Sandy Springs, Georgia, États-Unis, 30328
- Advanced Medical Research Pc
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Savannah, Georgia, États-Unis, 31419
- Divine Dermatology and Aesthetics
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Thomasville, Georgia, États-Unis, 31792
- McIntosh Clinic PC
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Idaho
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Boise, Idaho, États-Unis, 83706-1345
- Treasure Valley Medical Research
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Meridian, Idaho, États-Unis, 83642
- Velocity Clinical Research - Boise
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Illinois
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Skokie, Illinois, États-Unis, 60077
- NorthShore University HealthSystem Clinical Trials Center
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Indiana
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Indianapolis, Indiana, États-Unis, 46250
- Dawes Fretzin Clinical Research Group, LLC
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New Albany, Indiana, États-Unis, 47150
- Southern Indiana Clinical Trials
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Plainfield, Indiana, États-Unis, 46168
- The Indiana Clinical Trials Center PC
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Kentucky
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Bowling Green, Kentucky, États-Unis, 42104
- Equity Medical
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Murray, Kentucky, États-Unis, 42071
- Kentucky Advanced Medical Research LLC
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Louisiana
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Monroe, Louisiana, États-Unis, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, États-Unis, 20850
- Aesthetic and Dermatology Center
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Rockville, Maryland, États-Unis, 20850
- Derm Associates, PC
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Michigan
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Auburn Hills, Michigan, États-Unis, 48326
- Oakland Hills Dermatology
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Health System
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Flint, Michigan, États-Unis, 48532
- Onyx Clinical Research
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Missouri
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Saint Joseph, Missouri, États-Unis, 64506
- MediSearch Clinical Trials
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St Louis, Missouri, États-Unis, 63110
- Saint Louis University
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Nebraska
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Lincoln, Nebraska, États-Unis, 68505
- Somnos Clinical Research
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Nevada
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Reno, Nevada, États-Unis, 89509
- Skin Cancer and Dermatology Institute
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New Hampshire
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Portsmouth, New Hampshire, États-Unis, 03801
- Allcutis Research
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New Jersey
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Bridgewater, New Jersey, États-Unis, 08807
- The Dermatology Center of New Jersey
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- University of New Mexico
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New York
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Brooklyn, New York, États-Unis, 11211
- Ace Clinical Trials
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East Syracuse, New York, États-Unis, 13057
- Empire Dermatology
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Jackson Heights, New York, États-Unis, 11372
- Smart Medical Research Inc
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Kew Gardens, New York, États-Unis, 11415
- Forest Hills Dermatology Group
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New York, New York, États-Unis, 10016
- Pioneer Clinical Research New York
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New York, New York, États-Unis, 10075
- Cornell University - Weill Cornell Medicine
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Rochester, New York, États-Unis, 14609
- Rochester Clinical Research
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The Bronx, New York, États-Unis, 10467
- Yeshiva University - Montefiore Medical Center
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North Carolina
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Durham, North Carolina, États-Unis, 27713
- Duke South Durham
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Ohio
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Boardman, Ohio, États-Unis, 44512
- Optima Research
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Mayfield Heights, Ohio, États-Unis, 44124
- Apex Clinical Research Center LLC
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Oklahoma
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Chickasha, Oklahoma, États-Unis, 73018
- Epic Medical Research - Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73112
- Lynn Health Science Institute
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Oklahoma City, Oklahoma, États-Unis, 73120
- Dermatology and Aesthetics of Oklahoma
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Tulsa, Oklahoma, États-Unis, 74132
- Dermatology Research Center of Oklahoma, PLLC
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Tulsa, Oklahoma, États-Unis, 74137
- Essential Medical Research LLC
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Oregon
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Grants Pass, Oregon, États-Unis, 97527
- Velocity Clinical Research - Grants Pass
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Portland, Oregon, États-Unis, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19103
- Paddington Testing Company Inc
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital, Lifespan
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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North Charleston, South Carolina, États-Unis, 29420
- National Allergy and Asthma Research, LLC
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Summerville, South Carolina, États-Unis, 29486
- Coastal Pediatric Research
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Tennessee
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Morristown, Tennessee, États-Unis, 37813
- HealthStar Physicians Dermatology
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Texas
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Bellaire, Texas, États-Unis, 77401
- The University of Texas Health Science Center at Houston
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Cedar Park, Texas, États-Unis, 78613
- US Dermatology Partners Cedar Park
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Cypress, Texas, États-Unis, 77429
- Studies in Dermatology LLC
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Houston, Texas, États-Unis, 77037
- MedCare Pharma - Houston
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Houston, Texas, États-Unis, 77098
- Tranquil Clinical Research
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Kerrville, Texas, États-Unis, 78028
- Sante Clinical Research
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Lubbock, Texas, États-Unis, 79424
- Long and Harris Dermatology
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Mesquite, Texas, États-Unis, 75149
- Sms Clinical Research Limited Liability Company
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Missouri City, Texas, États-Unis, 77459
- Sienna Dermatology Research
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San Antonio, Texas, États-Unis, 78218
- Texas Dermatology and Laser Specialists
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Southlake, Texas, États-Unis, 76092
- Epiphany Dermatology
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Sugar Land, Texas, États-Unis, 77479
- Pioneer Research Solutions
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Utah
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Murray, Utah, États-Unis, 84107
- Tanner Clinic
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Providence, Utah, États-Unis, 84332
- Dermatology Research of Utah, dba Providence Dermatology
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South Jordan, Utah, États-Unis, 84095
- Jordan Valley Dermatology Center
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Virginia
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Franklin, Virginia, États-Unis, 23851
- Maria M Ona MD PC
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Washington
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Bellevue, Washington, États-Unis, 98007
- Northwest Clinical Research Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
12 ans à 17 ans (Enfant)
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Âge ≥ 12 à < 18 ans au Jour 1.
- Poids corporel ≥ 40 kg au dépistage.
- Antécédents de réponse inadéquate au TCS de puissance moyenne ou supérieure dans les 6 mois (avec ou sans TCI).
- Score EASI ≥ 16.
- Score vIGA-AD ≥ 3.
- ≥ 10 % de surface corporelle (BSA) d'atteinte de la MA.
- Pire prurit NRS ≥ 4.
Critère d'exclusion:
- Traitement avec un produit biologique dans les 12 semaines ou 5 demi-vies, selon la plus longue des deux, avant le jour 1.
Traitement avec l'un des médicaments ou thérapies suivants dans les 4 semaines ou 5 demi-vies, selon la plus longue des deux, avant le jour 1 :
- Corticostéroïdes systémiques
- Immunosuppresseurs systémiques
- Photothérapie
- Inhibiteurs oraux ou topiques de Janus kinase
Traitement avec l'un des médicaments ou thérapies suivants dans la semaine précédant le jour 1 :
- SDC
- TCI
- Inhibiteurs topiques de la phosphodiestérase de type 4
- Autres agents immunosuppresseurs topiques
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Bras A : Dose 1
Partie 1 (Période initiale) ; Semaine 0 à Semaine 24 : 1 dose de Rocatinlimab toutes les 4 semaines (Q4W) pendant 24 semaines avec une dose de charge à la Semaine 2 (+ corticostéroïdes topiques (TCS)/inhibiteur topique de la calcineurine (TCI) si dans la cohorte de thérapie combinée). Partie 2 (Période de maintenance) ; Semaine 24 à semaine 52 : 1re partie Les répondeurs seront rerandomisés à la semaine 24 pour recevoir Rocatinlimab Dose 1 Q4W ou toutes les 8 semaines (Q8W) pendant 28 semaines (+ TCS/TCI si dans la cohorte de traitement combiné). |
Injection sous-cutanée (SC)
Autres noms:
|
|
Expérimental: Bras B : Dose 2
Partie 1 (Période initiale) ; Semaine 0 à Semaine 24 : Rocatinlimab Dose 2 Q4W pendant 24 semaines avec dose de charge à la Semaine 2 (+TCS/TCI si dans la cohorte de thérapie combinée). Partie 2 (Période de maintenance) ; Semaine 24 à semaine 52 : 1re partie Les répondeurs seront rerandomisés à la semaine 24 pour recevoir Rocatinlimab Dose 2 Q4W ou Q8W pendant 28 semaines (avec TCS/TCI si dans la cohorte de traitement combiné). |
Injection sous-cutanée (SC)
Autres noms:
|
|
Expérimental: Bras C : Placebo
Partie 1 (Période initiale) ; Semaine 0 à Semaine 24 : Placebo Q4W pendant 24 semaines avec dose de charge à la Semaine 2 (+TCS/TCI si dans la cohorte de thérapie combinée). Partie 2 (Période de maintenance) ; Semaine 24 à semaine 52 : Partie 1 Les répondeurs seront réaffectés à la semaine 24 avec un placebo Q4W pendant 28 semaines (avec TCS/TCI si dans la cohorte de traitement combiné). |
Injection SC
|
|
Expérimental: Bras D : Dose 1 en ouvert
Partie 2; Semaine 24 à semaine 52 : les non-répondeurs de la partie 1 seront réaffectés à la semaine 24 avec Rocatinlimab en ouvert Dose 1 Q4W pendant 28 semaines (avec TCS/TCI si dans la cohorte de traitement combiné).
Les participants dans les bras A, B ou C de la période de maintenance seront réaffectés à la dose 1 en ouvert de Rocatinlimab Q4W (avec TCS/TCI si dans la cohorte de thérapie combinée) lors d'une rechute après la semaine 24.
|
Injection sous-cutanée (SC)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Délai: Baseline and Week 24
|
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity.
Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'.
For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?"
If "Yes," participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved EASI 75 at Week 24
Délai: Baseline and Week 24
|
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Délai: Baseline and Week 16
|
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Délai: Baseline and Week 16
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Délai: Baseline and Week 24
|
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Délai: Baseline and Week 24
|
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in POEM Score at Week 24
Délai: Baseline and Week 24
|
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Délai: Baseline and Week 24
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD skin pain intensity.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Délai: Baseline and Week 16
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD skin pain intensity.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Délai: Baseline and Week 24
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Délai: Baseline and Week 16
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Délai: Baseline and Week 24
|
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data.
SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
Délai: Baseline and Week 16
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Délai: Baseline and Week 16
|
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 16
|
|
Change From Baseline in SCORAD Itch VAS Score at Week 24
Délai: Baseline and Week 24
|
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Délai: Baseline and Week 24
|
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours.
Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance.
Participants were asked to rate the intensity of their sleep disturbance using this scale each day.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in level of sleep disturbance.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Délai: Baseline and Week 16
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
Délai: Baseline and Week 24
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Délai: Baseline and Week 24
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Délai: Baseline and Week 24
|
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
Délai: Up to Week 16
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 16
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
Délai: Up to Week 24
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 24
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Délai: Baseline and Week 16
|
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 16
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Délai: Baseline and Week 24
|
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 24
|
|
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Délai: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease.
The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
Délai: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease.
The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
Délai: Baseline and Week 24
|
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of child patients suffering from skin disease.
The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Délai: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Délai: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Délai: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the anxiety.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-depression Subscale Score at Week 24
Délai: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the depression.
|
Baseline and Week 24
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: MD, Amgen
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Blauvelt A, Deininger KM, Porter J, Sohn A, Qin S, McLeod L, Rylands AJ, Nelson L. Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan 9. doi: 10.1007/s13555-025-01634-5. Online ahead of print.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 avril 2023
Achèvement primaire (Réel)
27 février 2025
Achèvement de l'étude (Réel)
25 novembre 2025
Dates d'inscription aux études
Première soumission
20 janvier 2023
Première soumission répondant aux critères de contrôle qualité
20 janvier 2023
Première publication (Réel)
30 janvier 2023
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 août 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies génétiques, innées
- Maladies du système immunitaire
- Hypersensibilité immédiate
- Hypersensibilité
- Maladies de la peau
- Maladies de la peau, Génétique
- Maladies de la peau, eczémateux
- Dermatite
- Maladies et anomalies congénitales, héréditaires et néonatales
- Maladies de la peau et du tissu conjonctif
- Dermatite atopique
- Drogues de qualité inférieure
- Préparations pharmaceutiques
- Drogues contrefaites
Autres numéros d'identification d'étude
- 20210145
- 2022-501586-50 (Autre identifiant: EUCTR)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Données anonymisées sur les patients individuels pour les variables nécessaires pour répondre à la question de recherche spécifique dans une demande de partage de données approuvée.
Délai de partage IPD
Les demandes de partage de données relatives à cette étude seront examinées à partir de 18 mois après la fin de l'étude et soit 1) le produit et l'indication ont obtenu une autorisation de mise sur le marché aux États-Unis et en Europe, soit 2) le développement clinique du produit et/ou de l'indication s'arrête et les données ne seront pas soumises aux autorités réglementaires.
Il n'y a pas de date limite d'éligibilité pour soumettre une demande de partage de données pour cette étude.
Critères d'accès au partage IPD
Les chercheurs qualifiés peuvent soumettre une demande contenant les objectifs de la recherche, le(s) produit(s) Amgen et l'étude/les études Amgen dans leur portée, les critères/résultats d'intérêt, le plan d'analyse statistique, les exigences en matière de données, le plan de publication et les qualifications du/des chercheur(s).
En général, Amgen n'accepte pas les demandes externes de données individuelles sur les patients dans le but de réévaluer les problèmes d'innocuité et d'efficacité déjà abordés dans l'étiquetage du produit.
Les demandes sont examinées par un comité de conseillers internes.
S'il n'est pas approuvé, un comité d'examen indépendant sur le partage de données arbitrera et prendra la décision finale.
Après approbation, les informations nécessaires pour répondre à la question de recherche seront fournies en vertu d'un accord de partage de données.
Cela peut inclure des données individuelles anonymisées sur les patients et/ou des documents justificatifs disponibles, contenant des fragments de code d'analyse lorsqu'ils sont fournis dans les spécifications d'analyse.
De plus amples détails sont disponibles à l'URL ci-dessous.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .