Een studie ter evaluatie van Rocatinlimab bij matige tot ernstige atopische dermatitis (ROCKET-IGNITE) (ROCKET-Ignite)
25 juni 2026 bijgewerkt door: Amgen
Een 24 weken durend, gerandomiseerd, placebogecontroleerd, dubbelblind fase 3-onderzoek om de werkzaamheid, veiligheid en verdraagbaarheid van monotherapie met Rocatinlimab (AMG 451) te beoordelen bij volwassen proefpersonen met matige tot ernstige atopische dermatitis (AD)
Het doel van deze studie is om de werkzaamheid en veiligheid van rocatinlimab bij monotherapie te evalueren.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
769
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Buenos Aires
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CABA, Buenos Aires, Argentinië, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentinië, C1426ABP
- Fundacion Respirar
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Derqui, Pilar, Buenos Aires, Argentinië, B1629ODT
- Hospital Universitario Austral
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San Miguel, Buenos Aires, Argentinië, 1663
- Centro Dermatologico Schejtman
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentinië, 1425
- Instituto de Neumonología Y Dermatología
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Buenos Aires, Distrito Federal, Argentinië, 1425
- InAER - Investigaciones en Alergia y Enfermedades Respiratorias
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CABA, Distrito Federal, Argentinië, C1012AAY
- Conexa Investigacion Clinica SA
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Santa Fe Province
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Rosario, Santa Fe Province, Argentinië, 2000
- Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentinië, 2000
- Instituto de Diagnostico Abc American British Cowdray
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Rio de Janeiro, Brazilië, 20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
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São Paulo, Brazilië, 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, Brazilië, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazilië, 90160-093
- Hospital Ernesto Dornelles
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São Paulo
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Botucatu, São Paulo, Brazilië, 18618-686
- Upeclin-Pesq Clin FacMed Botucatu
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Santo André, São Paulo, Brazilië, 09060-870
- Fundacao Abc - Centro Univ Fmabc
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Santo André, São Paulo, Brazilië, 09030-010
- Hosp e Maternidade Dr Christovao da Gama
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Sorocaba, São Paulo, Brazilië, 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, China, 100044
- Peking University Peoples Hospital
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Shanghai, China, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, China, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, China, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, China, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, China, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Hebei
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Shijiazhuang, Hebei, China, 050000
- The First Hospital of Hebei Medical University
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Henan
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Nanyang, Henan, China, 473002
- Nanyang First Peoples Hospital
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Sanmenxia, Henan, China, 472099
- Sanmenxia Central Hospital
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Hubei
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Wuhan, Hubei, China, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Hunan
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Changsha, Hunan, China, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Jiangyin, Jiangsu, China, 214400
- Jiangyin Hospital of Traditional Chinese Medicine
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Wuxi, Jiangsu, China, 241023
- Wuxi Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, China, 130021
- The First Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, China, 110001
- The First Hospital of China Medical University
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Sichuan
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Chengdu, Sichuan, China, 610021
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China, 310004
- Zhejiang Provincial Peoples Hospital
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Taizhou, Zhejiang, China, 318000
- Taizhou Central Hospital
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Berlin, Duitsland, 10117
- Charite - Universitaetsmedizin Berlin, Campus Mitte
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Blankenfelde-Mahlow, Duitsland, 15831
- Dermatologische Gemeinschaftspraxis-Mahlow
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Bochum, Duitsland, 44793
- Hautarztpraxis Dr Niesmann und Dr Othlinghaus
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Darmstadt, Duitsland, 64283
- Rosenpark Research GmbH
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Dresden, Duitsland, 01307
- Universitaetsklinikum Dresden
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Düsseldorf, Duitsland, 40225
- Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
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Essen, Duitsland, 45174
- Universitaetsklinikum Essen
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Hamburg, Duitsland, 20246
- Institute for Health Services Research in Dermatology and Nursing
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Heidelberg, Duitsland, 69120
- Universitaetsklinikum Heidelberg
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Stuttgart, Duitsland, 70178
- Hautarztpraxis Dres Leitz und Kollegen
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Tübingen, Duitsland, 72076
- Universitaetsklinikum Tuebingen
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Wuppertal, Duitsland, 42287
- CentroDerm GmbH
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Athens, Griekenland, 12462
- University General Hospital Attikon
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Athens, Griekenland, 11521
- Athens Naval Hospital
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Athens, Griekenland, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Athens, Griekenland, 11527
- Thoracic General Hospital Of Athens Sotiria
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Ioannina, Griekenland, 45500
- University General Hospital Of Ioannina
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Larissa, Griekenland, 41110
- General University Hospital of Larissa
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Thessaloniki, Griekenland, 56403
- Papageorgiou General Hospital
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Veszprém, Hongarije, 8200
- MedMare Bt
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Chieti, Italië, 66100
- Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
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Milan, Italië, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Perugia, Italië, 06156
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
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Roma, Italië, 00161
- Azienda Ospedaliera Policlinico Umberto I
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Torino, Italië, 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, Japan, 480-1195
- Aichi Medical University Hospital
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Nagoya, Aichi-ken, Japan, 467-8602
- Nagoya City University Hospital
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Nagoya, Aichi-ken, Japan, 464-0821
- Central Clinic
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Nagoya, Aichi-ken, Japan, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japan, 819-0373
- Matsuo Clinic
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Fukuoka, Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukushima
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Fukushima, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Hokkaido
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Asahikawa-shi, Hokkaido, Japan, 070-8610
- Asahikawa City Hospital
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Ibaraki
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Inashiki-gun, Ibaraki, Japan, 300-0395
- Tokyo Medical University Ibaraki Medical Center
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Ishikawa-ken
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Nonoichi-shi, Ishikawa-ken, Japan, 921-8801
- Kaji Dermatology Clinic
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Iwate
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Morioka, Iwate, Japan, 020-8505
- Iwate Medical University Uchimaru Medical Center
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Kagawa-ken
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Marugame-shi, Kagawa-ken, Japan, 763-0074
- Takeoka Dermatology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan, 211-8533
- Nippon Medical School Musashikosugi Hospital
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Kyoto
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Kyoto, Kyoto, Japan, 607-8062
- Rakuwakai Otowa Hospital
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Kyoto, Kyoto, Japan, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Osaka
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Izumiotsu-shi, Osaka, Japan, 595-0025
- Mochida Dermatology Clinic
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Tochigi
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Shimotsuga-gun, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Tokyo
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Itabashi-ku, Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital
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Itabashi-ku, Tokyo, Japan, 173-8606
- Teikyo University Hospital
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Ivanić-Grad, Kroatië, 10310
- Special Hospital for Medical Rehabilitation Naftalan
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Zagreb, Kroatië, 10000
- University Hospital Centre Zagreb
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Zagreb, Kroatië, 10000
- Sestre milosrdnice University Hospital Center
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Riga, Letland, 1003
- Outpatient clinic Veselibas Centrs 4
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Riga, Letland, LV-1013
- Outpatient clinic Veselibascentrs 4
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Talsi, Letland, 3201
- Smite Aija practice in dermatology and venerology
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Born, Nederland, 6121 XK
- PreCare Trial and Recruitment
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Gdansk, Polen, 80-280
- AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
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Katowice, Polen, 40-611
- Centrum Medyczne Angelius Provita
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Lublin, Polen, 20-080
- Centrum Zdrowia i Urody Maxxmed
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Malbork, Polen, 82-200
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
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Nowa Sól, Polen, 67-100
- Twoja Przychodnia NCM
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Poznan, Polen, 61-293
- Twoja Przychodnia PCM
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Szczecin, Polen, 71-500
- Twoja Przychodnia SCM
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Tarnów, Polen, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
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Warsaw, Polen, 02-962
- Royalderm Agnieszka Nawrocka
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Wroclaw, Polen, 50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
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Lisbon, Portugal, 1998-018
- Hospital CUF Descobertas
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Lisbon, Portugal, 1500-458
- Hospital Lusiadas Lisboa
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Matosinhos Municipality, Portugal, 4464-513
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
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Porto, Portugal, 4099-001
- Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
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San Juan, Puerto Rico, 00909
- Clinical Research of Puerto Rico
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Banská Bystrica, Slowakije, 975 17
- Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
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Bratislava, Slowakije, 851 01
- Derma therapy, spol s ro
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Svidník, Slowakije, 089 01
- Sanare spol sro
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Topoľčany, Slowakije, 955 01
- Kaderma Majtan, sro
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Trnava, Slowakije, 917 75
- Fakultna Nemocnica Trnava
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Madrid, Spanje, 28006
- Hospital Universitario de La Princesa
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Madrid, Spanje, 28031
- Hospital Universitario Infanta Leonor
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Andalusia
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Córdoba, Andalusia, Spanje, 14004
- Hospital Universitario Reina Sofia
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Aragon
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Zaragoza, Aragon, Spanje, 50009
- Hospital Universitario Miguel Servet
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Canary Islands
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Las Palmas de Gran Canaria, Canary Islands, Spanje, 35010
- Hospital Universitario de Gran Canaria Doctor Negrin
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Catalonia
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Badalona, Catalonia, Spanje, 08916
- Hospital Universitari Germans Trias i Pujol
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L'Hospitalet de Llobregat, Catalonia, Spanje, 08907
- Hospital Universitari de Bellvitge
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Galicia
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Pontevedra, Galicia, Spanje, 36001
- Hospital Clínico Universitario de Santiago
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Madrid
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Pozuelo de Alarcón, Madrid, Spanje, 28223
- Hospital Universitario Quironsalud Madrid
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Valencia
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Valencia, Valencia, Spanje, 46026
- Hospital Universitari i Politecnic La Fe
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Kaohsiung City, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Tainan, Taiwan, 70403
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10449
- MacKay Memorial Hospital Taipei Branch
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Taoyuan, Taiwan, 33305
- Linkou Chang Gung Memorial Hospital
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Náchod, Tsjechië, 547 01
- Dermamedica, sro
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Ostrava, Tsjechië, 702 00
- CCR Ostrava sro
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Pardubice, Tsjechië, 530 02
- Pratia Pardubice as
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Prague, Tsjechië, 180 81
- Fakultní nemocnice Bulovka
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Prague, Tsjechië, 100 00
- Clintrial sro
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Prague, Tsjechië, 130 00
- Pratia Prague sro
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Ústí nad Labem, Tsjechië, 401 13
- Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35244
- Cahaba Dermatology and Skin Health Center
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85032
- Alliance Dermatology and Mohs Center
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California
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Anaheim, California, Verenigde Staten, 92801
- Anaheim Clinical Trials
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Fountain Valley, California, Verenigde Staten, 92708
- First OC Dermatology
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Glendale, California, Verenigde Staten, 91203
- Kaiser Permanente - Glendale Medical Center
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Long Beach, California, Verenigde Staten, 90805
- Long Beach Research Institute
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Los Angeles, California, Verenigde Staten, 90045
- Dermatology Research Associates
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Los Angeles, California, Verenigde Staten, 90027
- Kaiser Permanente Los Angeles Medical Center
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Sherman Oaks, California, Verenigde Staten, 91403
- Cura Clinical Research
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Colorado
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Centennial, Colorado, Verenigde Staten, 80112
- IMMUNOe Research Centers
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Florida
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Boca Raton, Florida, Verenigde Staten, 33486
- Skin Care Research Incorporated
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Delray Beach, Florida, Verenigde Staten, 33484
- Palm Beach Dermatology Group
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Homestead, Florida, Verenigde Staten, 33030
- Global Research Associates
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Miami, Florida, Verenigde Staten, 33175
- Healthy Life Research
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Miami Lakes, Florida, Verenigde Staten, 33014
- Savin Medical Group LLC
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Naples, Florida, Verenigde Staten, 34102
- Kirsch Dermatology LLC
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Orlando, Florida, Verenigde Staten, 32819
- Pure Skin Dermatology and Aesthetics
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St. Petersburg, Florida, Verenigde Staten, 33709
- Industrial Medicine Associates Ima Clinical Research Inc
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Tampa, Florida, Verenigde Staten, 33606
- Genesis Clinical Research LLC
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Idaho
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Boise, Idaho, Verenigde Staten, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- DeNova Research
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West Dundee, Illinois, Verenigde Staten, 60118
- Dundee Dermatology
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Indiana
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Plainfield, Indiana, Verenigde Staten, 46168
- The Indiana Clinical Trials Center PC
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Maryland
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Chevy Chase, Maryland, Verenigde Staten, 20815
- Institute for Asthma and Allergy
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Towson, Maryland, Verenigde Staten, 21204
- Continental Clinical Solutions, LLC
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Health System
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Flint, Michigan, Verenigde Staten, 48532
- Onyx Clinical Research
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Missouri
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Lee's Summit, Missouri, Verenigde Staten, 64064
- Dermatology and Skin Cancer Center of Lees Summit
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89106
- Jubilee Clinical Research Inc
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New Hampshire
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Portsmouth, New Hampshire, Verenigde Staten, 03801
- Allcutis Research, Llc - Portsmouth
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New Jersey
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Cherry Hill, New Jersey, Verenigde Staten, 08034
- Continental Clinical Solutions - Cherry Hill
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New York
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Hartsdale, New York, Verenigde Staten, 10530
- Industrial Medicine Associates Ima Clinical Research Inc
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New York, New York, Verenigde Staten, 10075
- Sadick Research Group
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28277
- Dermatology Specialists of Charlotte
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Charlotte, North Carolina, Verenigde Staten, 28277
- Onsite Clinical Solutions
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Wilmington, North Carolina, Verenigde Staten, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Verenigde Staten, 27103
- The Skin Surgery Center for Clinical Research
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Ohio
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Boardman, Ohio, Verenigde Staten, 44512
- Optima Research
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Columbus, Ohio, Verenigde Staten, 43213
- ClinOhio Research Services
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73118
- Unity Clinical Research
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Tulsa, Oklahoma, Verenigde Staten, 74132
- Dermatology Research Center of Oklahoma, PLLC
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Tulsa, Oklahoma, Verenigde Staten, 74137
- Essential Medical Research LLC
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Oregon
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Portland, Oregon, Verenigde Staten, 97239
- Oregon Health and Science University
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Pennsylvania
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Sugarloaf, Pennsylvania, Verenigde Staten, 18249
- DermDox Dermatology, LLC
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Tennessee
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Hermitage, Tennessee, Verenigde Staten, 37076
- Cumberland Skin Center
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Texas
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Dallas, Texas, Verenigde Staten, 75230
- Dermatology Treatment and Research Center PA
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The Woodlands, Texas, Verenigde Staten, 77380
- The Woodlands Dermatology Associates
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Virginia
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Lynchburg, Virginia, Verenigde Staten, 24501
- Education and Research Foundation Inc
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Washington
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Mill Creek, Washington, Verenigde Staten, 98012
- Frontier Derm Partners
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West Virginia
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Morgantown, West Virginia, Verenigde Staten, 26505
- West Virginia Research Institute
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Ansansi, Gyeonggido, Zuid -Korea, 15355
- Korea University Ansan Hospital
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Incheon, Zuid -Korea, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seoul, Zuid -Korea, 03080
- Seoul National University Hospital
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Seoul, Zuid -Korea, 05505
- Asan Medical Center
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Seoul, Zuid -Korea, 08308
- Korea University Guro Hospital
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Seoul, Zuid -Korea, 04564
- National Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 100 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- Leeftijd ≥ 18 jaar met een diagnose AD volgens de AAD Consensus Criteria (2014) aanwezig gedurende ten minste 6 maanden
- Voorgeschiedenis van onvoldoende respons op TCS (topische corticosteroïden) van middelmatige of hogere sterkte binnen 6 maanden (met of zonder lokale calcineurineremmers [TCI])
- EASI-score ≥16
- vIGA-AD-score ≥3
- ≥10% lichaamsoppervlak (BSA) van AD-betrokkenheid
- Slechtste pruritus numerieke beoordelingsschaal ≥ 4
Uitsluitingscriteria:
- Behandeling met een biologisch product binnen 12 weken of 5 halfwaardetijden, afhankelijk van welke langer is, voorafgaand aan Dag 1
Behandeling met een van de volgende medicijnen of therapieën binnen 4 weken of 5 halfwaardetijden, afhankelijk van welke langer is, voorafgaand aan dag 1:
- Systemische corticosteroïden
- Systemische immunosuppressiva
- Fototherapie
- Januskinaseremmers
Behandeling met een van de volgende medicijnen of therapieën binnen 1 week, voorafgaand aan dag 1:
- TCS van elke potentie
- TCI
- Geneesmiddel tegen jeuk
- Topische fosfodiësterase type 4-remmers
- Andere lokale immunosuppressiva
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm A
Rocatinlimab dosis 1 elke 4 weken (Q4W) + oplaaddosis in week 2
|
Deelnemers krijgen Rocatinlimab subcutaan toegediend.
Andere namen:
|
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Experimenteel: Arm B
Rocatinlimab dosis 2 Q4W + oplaaddosis in week 2
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Deelnemers krijgen Rocatinlimab subcutaan toegediend.
Andere namen:
|
|
Placebo-vergelijker: Arm C
Placebo Q4W+ oplaaddosis in week 2
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Deelnemers krijgen subcutaan een placebo toegediend.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: MD, Amgen
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 mei 2022
Primaire voltooiing (Werkelijk)
28 november 2024
Studie voltooiing (Werkelijk)
13 januari 2025
Studieregistratiedata
Eerst ingediend
24 mei 2022
Eerst ingediend dat voldeed aan de QC-criteria
31 mei 2022
Eerst geplaatst (Werkelijk)
1 juni 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
25 juni 2026
Laatst geverifieerd
1 februari 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20210142
- 2022-501540-15-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Geanonimiseerde individuele patiëntgegevens voor variabelen die nodig zijn om de specifieke onderzoeksvraag te beantwoorden in een goedgekeurd verzoek om gegevensuitwisseling.
IPD-tijdsbestek voor delen
Verzoeken tot het delen van gegevens met betrekking tot deze studie worden overwogen vanaf 18 maanden nadat de studie is beëindigd en ofwel 1) voor het product en de indicatie een vergunning voor het in de handel brengen is verleend in zowel de VS als Europa, of 2) de klinische ontwikkeling van het product en/of de indicatie wordt stopgezet en de gegevens zullen niet worden ingediend bij regelgevende instanties.
Er is geen einddatum voor het in aanmerking komen voor het indienen van een verzoek om gegevensuitwisseling voor dit onderzoek.
IPD-toegangscriteria voor delen
Gekwalificeerde onderzoekers kunnen een verzoek indienen met daarin de onderzoeksdoelstellingen, het/de Amgen-product(en) en de Amgen-studie(s) in de reikwijdte, eindpunten/uitkomsten van belang, plan voor statistische analyse, gegevensvereisten, publicatieplan en kwalificaties van de onderzoeker(s).
Over het algemeen willigt Amgen geen externe verzoeken in voor individuele patiëntgegevens met als doel veiligheids- en werkzaamheidskwesties die al in de productetikettering aan bod zijn gekomen, opnieuw te evalueren.
Verzoeken worden beoordeeld door een commissie van interne adviseurs.
Indien niet goedgekeurd, zal een onafhankelijk beoordelingspanel voor gegevensuitwisseling arbitreren en de uiteindelijke beslissing nemen.
Na goedkeuring wordt de informatie die nodig is om de onderzoeksvraag te beantwoorden verstrekt onder de voorwaarden van een overeenkomst voor het delen van gegevens.
Dit kunnen geanonimiseerde individuele patiëntgegevens en/of beschikbare ondersteunende documenten zijn, die fragmenten van de analysecode bevatten, indien voorzien in de analysespecificaties.
Verdere details zijn beschikbaar op de onderstaande URL.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .