Une étude évaluant le Rocatinlimab dans la dermatite atopique modérée à sévère (ROCKET-IGNITE) (ROCKET-Ignite)
25 juin 2026 mis à jour par: Amgen
Une étude de phase 3, de 24 semaines, randomisée, contrôlée par placebo, en double aveugle pour évaluer l'efficacité, l'innocuité et la tolérabilité du rocatinlimab (AMG 451) en monothérapie chez des sujets adultes atteints de dermatite atopique (DA) modérée à sévère
Le but de cette étude est d'évaluer l'efficacité et la tolérance du rocatinlimab en monothérapie.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
769
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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Berlin, Allemagne, 10117
- Charite - Universitaetsmedizin Berlin, Campus Mitte
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Blankenfelde-Mahlow, Allemagne, 15831
- Dermatologische Gemeinschaftspraxis-Mahlow
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Bochum, Allemagne, 44793
- Hautarztpraxis Dr Niesmann und Dr Othlinghaus
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Darmstadt, Allemagne, 64283
- Rosenpark Research GmbH
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Dresden, Allemagne, 01307
- Universitaetsklinikum Dresden
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Düsseldorf, Allemagne, 40225
- Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
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Essen, Allemagne, 45174
- Universitaetsklinikum Essen
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Hamburg, Allemagne, 20246
- Institute for Health Services Research in Dermatology and Nursing
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Heidelberg, Allemagne, 69120
- Universitaetsklinikum Heidelberg
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Stuttgart, Allemagne, 70178
- Hautarztpraxis Dres Leitz und Kollegen
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Tübingen, Allemagne, 72076
- Universitaetsklinikum Tuebingen
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Wuppertal, Allemagne, 42287
- CentroDerm GmbH
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Buenos Aires
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CABA, Buenos Aires, Argentine, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentine, C1426ABP
- Fundacion Respirar
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Derqui, Pilar, Buenos Aires, Argentine, B1629ODT
- Hospital Universitario Austral
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San Miguel, Buenos Aires, Argentine, 1663
- Centro Dermatologico Schejtman
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentine, 1425
- Instituto de Neumonología Y Dermatología
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Buenos Aires, Distrito Federal, Argentine, 1425
- InAER - Investigaciones en Alergia y Enfermedades Respiratorias
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CABA, Distrito Federal, Argentine, C1012AAY
- Conexa Investigacion Clinica SA
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Santa Fe Province
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Rosario, Santa Fe Province, Argentine, 2000
- Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentine, 2000
- Instituto de Diagnostico Abc American British Cowdray
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Rio de Janeiro, Brésil, 20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
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São Paulo, Brésil, 06454-010
- Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
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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, 90160-093
- Hospital Ernesto Dornelles
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São Paulo
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Botucatu, São Paulo, Brésil, 18618-686
- Upeclin-Pesq Clin FacMed Botucatu
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Santo André, São Paulo, Brésil, 09060-870
- Fundacao Abc - Centro Univ Fmabc
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Santo André, São Paulo, Brésil, 09030-010
- Hosp e Maternidade Dr Christovao da Gama
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Sorocaba, São Paulo, Brésil, 18040-425
- Consultoria Medica e Pesquisa Clinica Cmpc
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Alberta
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Edmonton, Alberta, Canada, T6G 1C3
- Alberta Derma Surgery Centre
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Edmonton, Alberta, Canada, T6H 4J8
- Vida Clinical Research
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Ontario
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Ajax, Ontario, Canada, L1S 7K8
- CCA Medical Research Corporation
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Barrie, Ontario, Canada, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Centre
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Hamilton, Ontario, Canada, L8L 3C3
- LEADER research
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Mississauga, Ontario, Canada, L4Y 4C5
- DermEdge Research Incorporated
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North York, Ontario, Canada, M3B 3S6
- Gordon Sussman Clinical Research Incorporated
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North York, Ontario, Canada, M3B 0A7
- Canadian Dermatology Centre
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Richmond Hill, Ontario, Canada, L4E 4L6
- Oak Ridges Aesthetics Centre
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc
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Québec, Quebec, Canada, G1G 3Y8
- Recherche Clinique Sigma Incorporated
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 2C1
- Skinsense Medical Research
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Beijing, Chine, 100044
- Peking University Peoples Hospital
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Shanghai, Chine, 200443
- Shanghai Skin Disease 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, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Chine, 350000
- The First Affiliated Hospital of Fujian 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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Hebei
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Shijiazhuang, Hebei, Chine, 050000
- The First Hospital of Hebei Medical University
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Henan
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Nanyang, Henan, Chine, 473002
- Nanyang First Peoples Hospital
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Sanmenxia, Henan, Chine, 472099
- Sanmenxia Central 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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Hunan
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Changsha, Hunan, Chine, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Jiangyin, Jiangsu, Chine, 214400
- Jiangyin Hospital of Traditional Chinese Medicine
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Wuxi, Jiangsu, Chine, 241023
- Wuxi Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Chine, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, Chine, 130021
- The First Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Chine, 110001
- The First Hospital of China Medical University
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Sichuan
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Chengdu, Sichuan, Chine, 610021
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Chine, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Chine, 310004
- Zhejiang Provincial Peoples 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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Incheon, Corée du Sud, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 05505
- Asan Medical Center
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Seoul, Corée du Sud, 08308
- Korea University Guro Hospital
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Seoul, Corée du Sud, 04564
- National Medical Center
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Ivanić-Grad, Croatie, 10310
- Special Hospital for Medical Rehabilitation Naftalan
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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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Madrid, Espagne, 28006
- Hospital Universitario de La Princesa
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Madrid, Espagne, 28031
- Hospital Universitario Infanta Leonor
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Andalusia
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Córdoba, Andalusia, Espagne, 14004
- Hospital Universitario Reina Sofia
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Aragon
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Zaragoza, Aragon, Espagne, 50009
- Hospital Universitario Miguel Servet
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Canary Islands
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Las Palmas de Gran Canaria, Canary Islands, Espagne, 35010
- Hospital Universitario de Gran Canaria Doctor Negrin
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Catalonia
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Badalona, Catalonia, Espagne, 08916
- Hospital Universitari Germans Trias i Pujol
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L'Hospitalet de Llobregat, Catalonia, Espagne, 08907
- Hospital Universitari de Bellvitge
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Galicia
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Pontevedra, Galicia, Espagne, 36001
- Hospital Clínico Universitario de Santiago
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Madrid
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Pozuelo de Alarcón, Madrid, Espagne, 28223
- Hospital Universitario Quironsalud Madrid
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Valencia
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Valencia, Valencia, Espagne, 46026
- Hospital Universitari i Politecnic La Fe
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Athens, Grèce, 12462
- University General Hospital Attikon
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Athens, Grèce, 11521
- Athens Naval Hospital
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Athens, Grèce, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Athens, Grèce, 11527
- Thoracic General Hospital Of Athens Sotiria
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Ioannina, Grèce, 45500
- University General Hospital Of Ioannina
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Larissa, Grèce, 41110
- General University Hospital of Larissa
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Thessaloniki, Grèce, 56403
- Papageorgiou General Hospital
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Veszprém, Hongrie, 8200
- MedMare Bt
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Chieti, Italie, 66100
- Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
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Milan, Italie, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Perugia, Italie, 06156
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
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Roma, Italie, 00161
- Azienda Ospedaliera Policlinico Umberto I
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Torino, Italie, 10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
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Aichi-ken
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Nagakute-shi, Aichi-ken, Japon, 480-1195
- Aichi Medical University Hospital
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Nagoya, Aichi-ken, Japon, 467-8602
- Nagoya City University Hospital
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Nagoya, Aichi-ken, Japon, 464-0821
- Central Clinic
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Nagoya, Aichi-ken, Japon, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japon, 819-0373
- Matsuo Clinic
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Fukuoka, Fukuoka, Japon, 814-0180
- Fukuoka University Hospital
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Fukushima
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Fukushima, Fukushima, Japon, 960-1295
- Fukushima Medical University Hospital
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Hokkaido
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Asahikawa-shi, Hokkaido, Japon, 070-8610
- Asahikawa City Hospital
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Ibaraki
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Inashiki-gun, Ibaraki, Japon, 300-0395
- Tokyo Medical University Ibaraki Medical Center
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Ishikawa-ken
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Nonoichi-shi, Ishikawa-ken, Japon, 921-8801
- Kaji Dermatology Clinic
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Iwate
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Morioka, Iwate, Japon, 020-8505
- Iwate Medical University Uchimaru Medical Center
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Kagawa-ken
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Marugame-shi, Kagawa-ken, Japon, 763-0074
- Takeoka Dermatology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japon, 211-8533
- Nippon Medical School Musashikosugi Hospital
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Kyoto
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Kyoto, Kyoto, Japon, 607-8062
- Rakuwakai Otowa Hospital
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Kyoto, Kyoto, Japon, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Osaka
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Izumiotsu-shi, Osaka, Japon, 595-0025
- Mochida Dermatology Clinic
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Tochigi
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Shimotsuga-gun, Tochigi, Japon, 321-0293
- Dokkyo Medical University Hospital
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Tokyo
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Itabashi-ku, Tokyo, Japon, 173-8610
- Nihon University Itabashi Hospital
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Itabashi-ku, Tokyo, Japon, 173-8606
- Teikyo University Hospital
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Lisbon, Le Portugal, 1998-018
- Hospital CUF Descobertas
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Lisbon, Le Portugal, 1500-458
- Hospital Lusiadas Lisboa
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Matosinhos Municipality, Le Portugal, 4464-513
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
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Porto, Le Portugal, 4099-001
- Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
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Riga, Lettonie, 1003
- Outpatient clinic Veselibas Centrs 4
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Riga, Lettonie, LV-1013
- Outpatient clinic Veselibascentrs 4
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Talsi, Lettonie, 3201
- Smite Aija practice in dermatology and venerology
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Born, Pays-Bas, 6121 XK
- PreCare Trial and Recruitment
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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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Lublin, Pologne, 20-080
- Centrum Zdrowia i Urody Maxxmed
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Malbork, Pologne, 82-200
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
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Nowa Sól, Pologne, 67-100
- Twoja Przychodnia NCM
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Poznan, Pologne, 61-293
- Twoja Przychodnia PCM
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Szczecin, Pologne, 71-500
- Twoja Przychodnia SCM
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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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Wroclaw, Pologne, 50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
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San Juan, Porto Rico, 00909
- Clinical Research of Puerto Rico
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Banská Bystrica, Slovaquie, 975 17
- Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
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Bratislava, Slovaquie, 851 01
- Derma therapy, spol s ro
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Svidník, Slovaquie, 089 01
- Sanare spol sro
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Topoľčany, Slovaquie, 955 01
- Kaderma Majtan, sro
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Trnava, Slovaquie, 917 75
- Fakultna Nemocnica Trnava
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Kaohsiung City, Taïwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Tainan, Taïwan, 70403
- National Cheng Kung University 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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Taipei, Taïwan, 10449
- MacKay Memorial Hospital Taipei Branch
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Taoyuan, Taïwan, 33305
- Linkou Chang Gung Memorial Hospital
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Náchod, Tchéquie, 547 01
- Dermamedica, sro
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Ostrava, Tchéquie, 702 00
- CCR Ostrava sro
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Pardubice, Tchéquie, 530 02
- Pratia Pardubice as
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Prague, Tchéquie, 180 81
- Fakultní nemocnice Bulovka
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Prague, Tchéquie, 100 00
- Clintrial sro
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Prague, Tchéquie, 130 00
- Pratia Prague sro
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Ústí nad Labem, Tchéquie, 401 13
- Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
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Alabama
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Birmingham, Alabama, États-Unis, 35244
- Cahaba Dermatology and Skin Health Center
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Arizona
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Phoenix, Arizona, États-Unis, 85032
- Alliance Dermatology and Mohs Center
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California
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Anaheim, California, États-Unis, 92801
- Anaheim Clinical Trials
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Fountain Valley, California, États-Unis, 92708
- First OC Dermatology
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Glendale, California, États-Unis, 91203
- Kaiser Permanente - Glendale Medical Center
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Long Beach, California, États-Unis, 90805
- Long Beach Research Institute
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Los Angeles, California, États-Unis, 90045
- Dermatology Research Associates
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Los Angeles, California, États-Unis, 90027
- Kaiser Permanente Los Angeles Medical Center
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Sherman Oaks, California, États-Unis, 91403
- Cura Clinical Research
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Colorado
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Centennial, Colorado, États-Unis, 80112
- IMMUNOe Research Centers
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Florida
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Boca Raton, Florida, États-Unis, 33486
- Skin Care Research Incorporated
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Delray Beach, Florida, États-Unis, 33484
- Palm Beach Dermatology Group
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Homestead, Florida, États-Unis, 33030
- Global Research Associates
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Miami, Florida, États-Unis, 33175
- Healthy Life Research
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Miami Lakes, Florida, États-Unis, 33014
- Savin Medical Group LLC
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Naples, Florida, États-Unis, 34102
- Kirsch Dermatology LLC
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Orlando, Florida, États-Unis, 32819
- Pure Skin Dermatology and Aesthetics
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St. Petersburg, Florida, États-Unis, 33709
- Industrial Medicine Associates Ima Clinical Research Inc
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Tampa, Florida, États-Unis, 33606
- Genesis Clinical Research LLC
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Idaho
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Boise, Idaho, États-Unis, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, États-Unis, 60611
- DeNova Research
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West Dundee, Illinois, États-Unis, 60118
- Dundee Dermatology
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Indiana
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Plainfield, Indiana, États-Unis, 46168
- The Indiana Clinical Trials Center PC
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Maryland
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Chevy Chase, Maryland, États-Unis, 20815
- Institute for Asthma and Allergy
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Towson, Maryland, États-Unis, 21204
- Continental Clinical Solutions, LLC
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Michigan
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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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Lee's Summit, Missouri, États-Unis, 64064
- Dermatology and Skin Cancer Center of Lees Summit
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Nevada
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Las Vegas, Nevada, États-Unis, 89106
- Jubilee Clinical Research Inc
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New Hampshire
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Portsmouth, New Hampshire, États-Unis, 03801
- Allcutis Research, Llc - Portsmouth
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New Jersey
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Cherry Hill, New Jersey, États-Unis, 08034
- Continental Clinical Solutions - Cherry Hill
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New York
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Hartsdale, New York, États-Unis, 10530
- Industrial Medicine Associates Ima Clinical Research Inc
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New York, New York, États-Unis, 10075
- Sadick Research Group
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North Carolina
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Charlotte, North Carolina, États-Unis, 28277
- Dermatology Specialists of Charlotte
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Charlotte, North Carolina, États-Unis, 28277
- Onsite Clinical Solutions
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Wilmington, North Carolina, États-Unis, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, États-Unis, 27103
- The Skin Surgery Center for Clinical Research
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Ohio
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Boardman, Ohio, États-Unis, 44512
- Optima Research
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Columbus, Ohio, États-Unis, 43213
- ClinOhio Research Services
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73118
- Unity Clinical Research
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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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Portland, Oregon, États-Unis, 97239
- Oregon Health and Science University
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Pennsylvania
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Sugarloaf, Pennsylvania, États-Unis, 18249
- DermDox Dermatology, LLC
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Tennessee
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Hermitage, Tennessee, États-Unis, 37076
- Cumberland Skin Center
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Texas
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Dallas, Texas, États-Unis, 75230
- Dermatology Treatment and Research Center PA
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The Woodlands, Texas, États-Unis, 77380
- The Woodlands Dermatology Associates
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Virginia
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Lynchburg, Virginia, États-Unis, 24501
- Education and Research Foundation Inc
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Washington
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Mill Creek, Washington, États-Unis, 98012
- Frontier Derm Partners
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West Virginia
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Morgantown, West Virginia, États-Unis, 26505
- West Virginia Research Institute
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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
18 ans à 100 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Âge ≥ 18 ans avec un diagnostic de MA selon les critères de consensus AAD (2014) présent depuis au moins 6 mois
- Antécédents de réponse inadéquate au TCS (corticostéroïde topique) de puissance moyenne ou supérieure dans les 6 mois (avec ou sans inhibiteurs topiques de la calcineurine [TCI])
- Score EASI ≥16
- Score vIGA-AD ≥3
- ≥ 10 % de surface corporelle (BSA) d'implication AD
- Échelle d'évaluation numérique du pire prurit ≥ 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 de la Janus kinase
Traitement avec l'un des médicaments ou thérapies suivants dans la semaine précédant le jour 1 :
- TCS de toute puissance
- TCI
- Médicament antiprurigineux
- 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 parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Bras A
Rocatinlimab Dose 1 toutes les 4 semaines (Q4W) + dose de charge à la semaine 2
|
Les participants recevront du Rocatinlimab par voie sous-cutanée.
Autres noms:
|
|
Expérimental: Bras B
Rocatinlimab Dose 2 Q4W + dose de charge à la semaine 2
|
Les participants recevront du Rocatinlimab par voie sous-cutanée.
Autres noms:
|
|
Comparateur placebo: Bras C
Placebo Q4W+ dose de charge à la semaine 2
|
Les participants recevront un placebo par voie sous-cutanée.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (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," the participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, the 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 ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (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 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.
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 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 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
|
|
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (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 Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Délai: Baseline and Week 24
|
The severity of facial AD was assessed using the Facial AD Severity Scale (FASS).
The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Délai: Baseline and Week 24
|
The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS).
The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and 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 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 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 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 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 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 adult 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
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 adult 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
|
|
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 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 a greater impact of AD.
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 a greater impact of AD.
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 impact of AD.
|
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 a greater impact of AD.
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 impact of AD.
|
Baseline and Week 24
|
|
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
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily 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 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
|
|
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
|
|
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.
Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
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 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 a greater impact of AD.
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
|
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.
- Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
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)
31 mai 2022
Achèvement primaire (Réel)
28 novembre 2024
Achèvement de l'étude (Réel)
13 janvier 2025
Dates d'inscription aux études
Première soumission
24 mai 2022
Première soumission répondant aux critères de contrôle qualité
31 mai 2022
Première publication (Réel)
1 juin 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 juin 2026
Dernière vérification
1 février 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
Autres numéros d'identification d'étude
- 20210142
- 2022-501540-15-00 (Ctis)
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 .