Studie k hodnocení Rocatinlimabu (AMG 451) u dospívajících se středně těžkou až těžkou atopickou dermatitidou (AD) (ROCKET-ASTRO)
6. srpna 2026 aktualizováno: Amgen
Randomizovaná, 52týdenní, placebem kontrolovaná, dvojitě zaslepená studie fáze 3 s opakovanou randomizací k posouzení účinnosti, bezpečnosti a snášenlivosti rocatinlimabu (AMG 451) u dospívajících pacientů se středně těžkou až těžkou atopickou dermatitidou (AD) ( ROCKET-ASTRO)
Účelem této studie je zhodnotit účinnost a bezpečnost rocatinlimabu v monoterapii a kombinované terapii u dospívajících subjektů.
Přehled studie
Postavení
Postavení
Dokončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
532
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Amgen Call Center
- Telefonní číslo: 866-572-6436
- E-mail: medinfo@amgen.com
Studijní místa
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Brussels, Belgie, 1070
- Hopital Erasme
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Brussels, Belgie, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Belgie, 9000
- Universitair Ziekenhuis Gent
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Liège, Belgie, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Maldegem, Belgie, 9990
- Dermatologie Maldegem
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Rio de Janeiro, Brazílie, 20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
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Espírito Santo
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Vitória, Espírito Santo, Brazílie, 29055-450
- Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
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Estado de Bahia
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Salvador, Estado de Bahia, Brazílie, 41820-020
- Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazílie, 30575-180
- Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazílie, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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São Paulo
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Jaú, São Paulo, Brazílie, 17201-130
- Cecip Centro Est Clin Int Paulista
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Ribeirão Preto, São Paulo, Brazílie, 14026-020
- Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
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São José do Rio Preto, São Paulo, Brazílie, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brazílie, 01228-200
- Instituto Pesquisa e Ensino em Saúde Infantil
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São Paulo, São Paulo, Brazílie, 05403-002
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Osorno, Chile, 5310644
- Centro Dermatologico Dermisur
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Santiago, Chile, 7640881
- Clinica Dermacross SA
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Santiago, Chile, 7580206
- Centro Medico Skinmed Spa
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Santiago, Chile, 8380465
- Fundacion Innovacion Cardiovascular
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Santiago, Chile, 8420383
- Centro Internacional de Estudios Clínicos
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Ivanić-Grad, Chorvatsko, 10310
- Special Hospital for Medical Rehabilitation Naftalan
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Osijek, Chorvatsko, 31000
- University Hospital Centre Osijek
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Zagreb, Chorvatsko, 10000
- University Hospital Centre Zagreb
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Zagreb, Chorvatsko, 10000
- Sestre milosrdnice University Hospital Center
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Zagreb, Chorvatsko, 10000
- Children s Hospital Zagreb
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Antony, Francie, 92160
- Hopital Prive d Antony
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Brest, Francie, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Marseille, Francie, 13285
- Hôpital Saint-Joseph
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Nantes, Francie, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Rennes, Francie, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Francie, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Toulouse, Francie, 31059
- Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
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Milan, Itálie, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Naples, Itálie, 80131
- Azienda Ospedaliera Universitaria Luigi Vanvitelli
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Perugia, Itálie, 06129
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
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Torino, Itálie, 10126
- Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
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Bear Sheva, Izrael, 8410101
- Soroka Medical Center
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Ramat Gan, Izrael, 5262000
- Sheba medical center
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Tel Aviv, Izrael, 6423906
- Sourasky Medical Center
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Aichi-ken
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Nagoya, Aichi-ken, Japonsko, 464-0821
- Central Clinic
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Chiba
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Matsudo-shi, Chiba, Japonsko, 271-0092
- Miyata Dermatology Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japonsko, 819-0373
- Matsuo Clinic
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Hokkaido
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Asahikawa-shi, Hokkaido, Japonsko, 070-8610
- Asahikawa City Hospital
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Obihiro-shi, Hokkaido, Japonsko, 080-0013
- Takagi Dermatological Clinic
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Hyōgo
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Akashi-shi, Hyōgo, Japonsko, 674-0068
- Yoshimura Child Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japonsko, 890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Yokohama, Kanagawa, Japonsko, 231-8682
- Yokohama City Minato Red Cross Hospital
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Yokohama, Kanagawa, Japonsko, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japonsko, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, Japonsko, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, Japonsko, 572-0838
- Yoshioka Dermatology Clinic
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Sakai-shi, Osaka, Japonsko, 593-8324
- Dermatology and Ophthalmology Kume Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japonsko, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Setagaya-ku, Tokyo, Japonsko, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, Japonsko, 141-8625
- NTT Medical Center Tokyo
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Ansansi, Gyeonggido, Jižní Korea, 15355
- Korea University Ansan Hospital
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Seoul, Jižní Korea, 03080
- Seoul National University Hospital
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Seoul, Jižní Korea, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Jižní Korea, 01830
- Nowon Eulji Medical Center, Eulji University
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Seoul, Jižní Korea, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, Jižní Korea, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, Jižní Korea, 08308
- Korea University Guro Hospital
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Seoul, Jižní Korea, 06973
- Chung-Ang University Hospital
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Seoul, Jižní Korea, 07441
- Hallym University Kangnam Sacred Heart Hospital
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Seoul, Jižní Korea, 04564
- National Medical Center
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Seoul, Jižní Korea, 07804
- Ewha Womans University Seoul Hospital
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Alberta
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Calgary, Alberta, Kanada, T3K 6B8
- Rejuvenation Dermatology Laser Calgary North
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Ontario
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Markham, Ontario, Kanada, L3P 1X3
- Lynderm Research Inc
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Newmarket, Ontario, Kanada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Kanada, L2H 1H5
- Allergy Research Canada Incorporated
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Windsor, Ontario, Kanada, N8T 1E6
- XLR8 Medical Research, Incorporated
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7K 2C1
- Skinsense Medical Research
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Budapest, Maďarsko, 1033
- Clinexpert Kft
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Debrecen, Maďarsko, 4032
- Debreceni Egyetem Klinikai Kozpont
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Debrecen, Maďarsko, 4031
- Derma-B Egeszsegugyi es Szolgaltato Kft
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Kaposvár, Maďarsko, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Toluca, Mexiko, 50090
- Phylasis Clinicas Research Toluca
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Bad Bentheim, Německo, 48455
- Fachklinik Bad Bentheim
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Bonn, Německo, 53127
- Universitaetsklinikum Bonn
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Darmstadt, Německo, 64283
- Rosenpark Research GmbH
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Dresden, Německo, 01307
- Universitaetsklinikum Dresden
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Erlangen, Německo, 91054
- Universitaetsklinikum Erlangen
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Frankfurt am Main, Německo, 60590
- Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
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Leipzig, Německo, 04103
- Velocity Clinical Research
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Mainz, Německo, 55101
- Johannes Gutenberg Universitaet Mainz
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Gdansk, Polsko, 80-214
- Uniwersyteckie Centrum Kliniczne
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Gdansk, Polsko, 80-280
- AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
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Katowice, Polsko, 40-611
- Centrum Medyczne Angelius Provita
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Katowice, Polsko, 40-600
- GynCentrum Sp zoo NZOZ Holsamed
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Krakow, Polsko, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Krakow, Polsko, 31-559
- Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
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Lodz, Polsko, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polsko, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin, Polsko, 20-011
- Clinical Best Solutions Sp zoo Spolka komandytowa
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Sosnowiec, Polsko, 41-200
- Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
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Tarnów, Polsko, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
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Warsaw, Polsko, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Polsko, 02-953
- Klinika Ambroziak Dermatologia
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Warsaw, Polsko, 00-716
- Klinika Osipowicz and Turkowski Sp zoo
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Warsaw, Polsko, 01-817
- High Med Przychodnia Specjalistyczna
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Wroclaw, Polsko, 50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
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San Juan, Portoriko, 00917
- GCM Medical Group, PSC
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San Juan, Portoriko, 00909
- Clinical Research of Puerto Rico
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Bucharest, Rumunsko, 011216
- Dr Leventer Centre Clinica Dermatologie Bucuresti
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Cluj-Napoca, Rumunsko, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Cluj-Napoca, Rumunsko, 400105
- Derma Cluj
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Alabama
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Birmingham, Alabama, Spojené státy, 35244
- Cahaba Dermatology and Skin Health Center
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Cullman, Alabama, Spojené státy, 35058
- AllerVie Clinical Research- Cullman
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Arizona
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Tucson, Arizona, Spojené státy, 85745
- Eclipse Clinical Research
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Arkansas
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North Little Rock, Arkansas, Spojené státy, 72117
- Arkansas Research Trials, LLC
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California
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Fremont, California, Spojené státy, 94538
- Center for Dermatology Clinical Research Inc
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Fullerton, California, Spojené státy, 92831
- Doc1 Healthcare Systems Incorporated
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Inglewood, California, Spojené státy, 90301
- Axon Clinical Research
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Laguna Niguel, California, Spojené státy, 92677
- Avance Clinical Trials
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Palmdale, California, Spojené státy, 93551
- Cura Clinical Research
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Sacramento, California, Spojené státy, 95815
- Integrative Skin Science and Research
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Sacramento, California, Spojené státy, 95816
- University of California at Davis Medical Center
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San Diego, California, Spojené státy, 92123
- Allergy and Asthma Medical Group and Research Center
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San Diego, California, Spojené státy, 92123
- University of California at San Diego Rady Childrens Hospital San Diego
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Santa Monica, California, Spojené státy, 90404
- Clinical Science Institute
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Sherman Oaks, California, Spojené státy, 91403
- Cura Clinical Research Sherman Oaks
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Colorado
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Denver, Colorado, Spojené státy, 80209
- Velocity Clinical Research - Denver
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20010
- Childrens National Medical Center
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Florida
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Brandon, Florida, Spojené státy, 33511
- Clinical Research of Brandon
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Clearwater, Florida, Spojené státy, 33761
- Academic Alliance in Dermatology - Saint Petersburg Office
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Coral Springs, Florida, Spojené státy, 33071
- Corazon United States of America, LLC doing business as Life Clinical Trials
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Delray Beach, Florida, Spojené státy, 33484
- Palm Beach Dermatology Group
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Hialeah, Florida, Spojené státy, 33012
- Direct Helpers Research Center
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Margate, Florida, Spojené státy, 33063
- Glick Skin Institute
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Miami, Florida, Spojené státy, 33155
- Miami Clinical Research
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Miami, Florida, Spojené státy, 33176
- ara Professionals Limited Liability Corporation
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Miami Lakes, Florida, Spojené státy, 33014
- Savin Medical Group LLC
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Miami Lakes, Florida, Spojené státy, 33016
- Angels Clinical Research Institute
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Miami Lakes, Florida, Spojené státy, 33014
- Deluxe Health Care LLC
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Orange City, Florida, Spojené státy, 32763
- Optimal Research Sites, LLC
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Orlando, Florida, Spojené státy, 32819
- Clinical Research Investments
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Orlando, Florida, Spojené státy, 32819
- Clinical Associates of Orlando Limited Liability Company
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Tampa, Florida, Spojené státy, 33612
- University of South Florida
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Georgia
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Columbus, Georgia, Spojené státy, 31904
- Centricity Research Columbus
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Sandy Springs, Georgia, Spojené státy, 30328
- Advanced Medical Research Pc
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Savannah, Georgia, Spojené státy, 31419
- Divine Dermatology and Aesthetics
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Thomasville, Georgia, Spojené státy, 31792
- McIntosh Clinic PC
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Idaho
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Boise, Idaho, Spojené státy, 83706-1345
- Treasure Valley Medical Research
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Meridian, Idaho, Spojené státy, 83642
- Velocity Clinical Research - Boise
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Illinois
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Skokie, Illinois, Spojené státy, 60077
- NorthShore University HealthSystem Clinical Trials Center
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Indiana
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Indianapolis, Indiana, Spojené státy, 46250
- Dawes Fretzin Clinical Research Group, LLC
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New Albany, Indiana, Spojené státy, 47150
- Southern Indiana Clinical Trials
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Plainfield, Indiana, Spojené státy, 46168
- The Indiana Clinical Trials Center PC
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Kentucky
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Bowling Green, Kentucky, Spojené státy, 42104
- Equity Medical
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Murray, Kentucky, Spojené státy, 42071
- Kentucky Advanced Medical Research LLC
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Louisiana
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Monroe, Louisiana, Spojené státy, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Spojené státy, 20850
- Aesthetic and Dermatology Center
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Rockville, Maryland, Spojené státy, 20850
- Derm Associates, PC
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Michigan
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Auburn Hills, Michigan, Spojené státy, 48326
- Oakland Hills Dermatology
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Detroit, Michigan, Spojené státy, 48202
- Henry Ford Health System
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Flint, Michigan, Spojené státy, 48532
- Onyx Clinical Research
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Missouri
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Saint Joseph, Missouri, Spojené státy, 64506
- MediSearch Clinical Trials
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St Louis, Missouri, Spojené státy, 63110
- Saint Louis University
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Nebraska
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Lincoln, Nebraska, Spojené státy, 68505
- Somnos Clinical Research
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Nevada
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Reno, Nevada, Spojené státy, 89509
- Skin Cancer and Dermatology Institute
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New Hampshire
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Portsmouth, New Hampshire, Spojené státy, 03801
- Allcutis Research
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New Jersey
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Bridgewater, New Jersey, Spojené státy, 08807
- The Dermatology Center of New Jersey
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87102
- University of New Mexico
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New York
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Brooklyn, New York, Spojené státy, 11211
- Ace Clinical Trials
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East Syracuse, New York, Spojené státy, 13057
- Empire Dermatology
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Jackson Heights, New York, Spojené státy, 11372
- Smart Medical Research Inc
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Kew Gardens, New York, Spojené státy, 11415
- Forest Hills Dermatology Group
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New York, New York, Spojené státy, 10016
- Pioneer Clinical Research New York
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New York, New York, Spojené státy, 10075
- Cornell University - Weill Cornell Medicine
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Rochester, New York, Spojené státy, 14609
- Rochester Clinical Research
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The Bronx, New York, Spojené státy, 10467
- Yeshiva University - Montefiore Medical Center
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North Carolina
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Durham, North Carolina, Spojené státy, 27713
- Duke South Durham
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Ohio
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Boardman, Ohio, Spojené státy, 44512
- Optima Research
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Mayfield Heights, Ohio, Spojené státy, 44124
- Apex Clinical Research Center LLC
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Oklahoma
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Chickasha, Oklahoma, Spojené státy, 73018
- Epic Medical Research - Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73112
- Lynn Health Science Institute
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Oklahoma City, Oklahoma, Spojené státy, 73120
- Dermatology and Aesthetics of Oklahoma
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Tulsa, Oklahoma, Spojené státy, 74132
- Dermatology Research Center of Oklahoma, PLLC
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Tulsa, Oklahoma, Spojené státy, 74137
- Essential Medical Research LLC
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Oregon
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Grants Pass, Oregon, Spojené státy, 97527
- Velocity Clinical Research - Grants Pass
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Portland, Oregon, Spojené státy, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19103
- Paddington Testing Company Inc
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Rhode Island Hospital, Lifespan
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425
- Medical University of South Carolina
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North Charleston, South Carolina, Spojené státy, 29420
- National Allergy and Asthma Research, LLC
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Summerville, South Carolina, Spojené státy, 29486
- Coastal Pediatric Research
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Tennessee
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Morristown, Tennessee, Spojené státy, 37813
- HealthStar Physicians Dermatology
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Texas
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Bellaire, Texas, Spojené státy, 77401
- The University of Texas Health Science Center at Houston
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Cedar Park, Texas, Spojené státy, 78613
- US Dermatology Partners Cedar Park
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Cypress, Texas, Spojené státy, 77429
- Studies in Dermatology LLC
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Houston, Texas, Spojené státy, 77037
- MedCare Pharma - Houston
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Houston, Texas, Spojené státy, 77098
- Tranquil Clinical Research
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Kerrville, Texas, Spojené státy, 78028
- Sante Clinical Research
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Lubbock, Texas, Spojené státy, 79424
- Long and Harris Dermatology
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Mesquite, Texas, Spojené státy, 75149
- Sms Clinical Research Limited Liability Company
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Missouri City, Texas, Spojené státy, 77459
- Sienna Dermatology Research
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San Antonio, Texas, Spojené státy, 78218
- Texas Dermatology and Laser Specialists
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Southlake, Texas, Spojené státy, 76092
- Epiphany Dermatology
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Sugar Land, Texas, Spojené státy, 77479
- Pioneer Research Solutions
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Utah
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Murray, Utah, Spojené státy, 84107
- Tanner Clinic
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Providence, Utah, Spojené státy, 84332
- Dermatology Research of Utah, dba Providence Dermatology
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South Jordan, Utah, Spojené státy, 84095
- Jordan Valley Dermatology Center
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Virginia
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Franklin, Virginia, Spojené státy, 23851
- Maria M Ona MD PC
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Washington
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Bellevue, Washington, Spojené státy, 98007
- Northwest Clinical Research Center
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-
-
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Kaohsiung City, Tchaj-wan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Tchaj-wan, 10002
- National Taiwan University Hospital
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Taipei, Tchaj-wan, 11217
- Taipei Veterans General Hospital
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Taoyuan, Tchaj-wan, 33305
- Linkou Chang Gung Memorial Hospital
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-
-
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Bangkok, Thajsko, 10330
- King Chulalongkorn Memorial Hospital
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Bangkok, Thajsko, 10700
- Siriraj Hospital
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Chiang Mai, Thajsko, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Pathum Thani, Thajsko, 12120
- Thammasat University Hospital
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-
-
-
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Changsha, Čína, 410007
- Hunan Childrens Hospital
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Shenzhen, Čína, 518038
- Shenzhen Childrens Hospital
-
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Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100191
- Peking University Third Hospital
-
Beijing, Beijing Municipality, Čína, 100020
- Childrens Hospital Capital Institute of Pediatrics
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Beijing, Beijing Municipality, Čína, 100044
- Peking University Peoples Hospital
-
Beijing, Beijing Municipality, Čína, 100045
- Beijing Childrens Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Čína, 400014
- Childrens Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Čína, 510091
- Dermatology Hospital of Southern Medical University
-
Guangzhou, Guangdong, Čína, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
-
Guangzhou, Guangdong, Čína, 510080
- The First Affiliated Hospital Sun-Yat Sen University
-
-
Henan
-
Nanyang, Henan, Čína, 473002
- Nanyang First Peoples Hospital
-
-
Hubei
-
Wuhan, Hubei, Čína, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
-
Wuhan, Hubei, Čína, 430014
- The Central Hospital of Wuhan
-
-
Jiangsu
-
Jiangyin, Jiangsu, Čína, 214400
- Jiangyin Hospital of Traditional Chinese Medicine
-
-
Jilin
-
Changchun, Jilin, Čína, 130021
- The First Bethune Hospital of Jilin University
-
-
Liaoning
-
Dalian, Liaoning, Čína, 116011
- Dalian Women and Childrens Medical Group
-
-
Ningxia
-
Yinchuan, Ningxia, Čína, 750003
- General Hospital of Ningxia Medical University
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Čína, 200443
- Shanghai Skin Disease Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Čína, 610021
- Chengdu Second Peoples Hospital
-
Suining, Sichuan, Čína, 629099
- Suining Central Hospital
-
-
Yunnan
-
Kunming, Yunnan, Čína, 650103
- Kunming Childrens Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310020
- Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
-
Ningbo, Zhejiang, Čína, 315010
- Ningbo NO 2 Hospital
-
Taizhou, Zhejiang, Čína, 318000
- Taizhou Central Hospital
-
-
-
-
-
Athens, Řecko, 11521
- Athens Naval Hospital
-
Athens, Řecko, 11527
- Thoracic General Hospital Of Athens Sotiria
-
Athens, Řecko, 11527
- Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
-
Thessaloniki, Řecko, 54643
- Ippokratio General Hospital of Thessaloniki
-
-
-
-
-
Madrid, Španělsko, 28046
- Hospital Universitario La Paz
-
Madrid, Španělsko, 28007
- Hospital General Universitario Gregorio Marañón
-
-
Catalonia
-
Barcelona, Catalonia, Španělsko, 08041
- Hospital de La Santa Creu i Sant Pau
-
Esplugues de Llobregat, Catalonia, Španělsko, 08950
- Hospital Sant Joan de Déu
-
-
Navarre
-
Pamplona, Navarre, Španělsko, 31008
- Clinica Universidad de Navarra
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
12 let až 17 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Věk ≥ 12 až < 18 let v den 1.
- Tělesná hmotnost ≥ 40 kg při screeningu.
- Anamnéza nedostatečné odpovědi na TCS střední nebo vyšší účinnosti během 6 měsíců (s nebo bez TCI).
- Skóre EASI ≥ 16.
- vIGA-AD skóre ≥ 3.
- ≥10 % tělesného povrchu (BSA) postižení AD.
- Nejhorší pruritus NRS ≥ 4.
Kritéria vyloučení:
- Léčba biologickým přípravkem do 12 týdnů nebo 5 poločasů, podle toho, co je delší, před 1. dnem.
Léčba kterýmkoli z následujících léků nebo terapií během 4 týdnů nebo 5 poločasů, podle toho, co je delší, před 1. dnem:
- Systémové kortikosteroidy
- Systémová imunosupresiva
- Fototerapie
- Perorální nebo topické inhibitory Janus kinázy
Léčba kterýmkoli z následujících léků nebo terapií během 1 týdne před 1. dnem:
- TCS
- TCI
- Lokální inhibitory fosfodiesterázy typu 4
- Další lokální imunosupresiva
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Dvojnásobek
Počet zbraní
4
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Rameno A: Dávka 1
Část 1 (Počáteční období); Týden 0 až týden 24: Rocatinlimab Dávka 1 každé 4 týdny (Q4W) po dobu 24 týdnů s nasycovací dávkou v týdnu 2 (+ topické kortikosteroidy (TCS)/topický inhibitor kalcineurinu (TCI), pokud je součástí kohorty kombinované terapie). Část 2 (Období údržby); Týden 24 až týden 52: Část 1 respondenti budou znovu randomizováni v týdnu 24 na dávku rocatinlimabu 1 Q4W nebo každých 8 týdnů (Q8W) po dobu 28 týdnů (+ TCS/TCI, pokud jsou v rámci kohorty kombinované terapie). |
Subkutánní (SC) injekce
Ostatní jména:
|
|
Experimentální: Rameno B: Dávka 2
Část 1 (Počáteční období); Týden 0 až týden 24: Rocatinlimab Dávka 2 Q4W po dobu 24 týdnů s nasycovací dávkou v Týdnu 2 (+TCS/TCI, pokud je součástí kohorty kombinované terapie). Část 2 (Období údržby); Týden 24 až týden 52: Část 1 respondenti budou znovu randomizováni v týdnu 24 na Rocatinlimab Dávka 2 Q4W nebo Q8W po dobu 28 týdnů (s TCS/TCI, pokud jsou v rámci kohorty kombinované terapie). |
Subkutánní (SC) injekce
Ostatní jména:
|
|
Experimentální: Rameno C: Placebo
Část 1 (Počáteční období); Týden 0 až týden 24: Placebo Q4W po dobu 24 týdnů s nasycovací dávkou v týdnu 2 (+TCS/TCI v rámci kohorty kombinované terapie). Část 2 (Období údržby); Týden 24 až týden 52: Část 1 respondéři budou přeřazeni v týdnu 24 s placebem Q4W na 28 týdnů (s TCS/TCI, pokud jsou v rámci kohorty kombinované terapie). |
SC injekce
|
|
Experimentální: Rameno D: Otevřená dávka 1
Část 2; Týden 24 až 52: Část 1 Non-Responders bude přeřazena v týdnu 24 s Rocatinlimabem Open-label Dávka 1 Q4W po dobu 28 týdnů (s TCS/TCI, pokud jsou v rámci kohorty kombinované terapie).
Účastníkům v udržovacím období ramen A, B nebo C bude po relapsu po 24. týdnu přeřazena otevřená dávka 1 Rocatinlimabu Q4W (s TCS/TCI, pokud je součástí kohorty kombinované terapie).
|
Subkutánní (SC) injekce
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Časové okno: Baseline and Week 24
|
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity.
Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'.
For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?"
If "Yes," participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved EASI 75 at Week 24
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Časové okno: 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
Časové okno: Baseline and Week 16
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Časové okno: Baseline and Week 24
|
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline and Week 16
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Časové okno: 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
Časové okno: Baseline and Week 16
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Časové okno: 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
Časové okno: Baseline and Week 24
|
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Časové okno: Baseline and Week 24
|
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours.
Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance.
Participants were asked to rate the intensity of their sleep disturbance using this scale each day.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in level of sleep disturbance.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Časové okno: Baseline and Week 16
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
Časové okno: Baseline and Week 24
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Časové okno: Baseline and Week 24
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Časové okno: Baseline and Week 24
|
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
Časové okno: Up to Week 16
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 16
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
Časové okno: Up to Week 24
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 24
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Časové okno: Baseline and Week 16
|
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 16
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Časové okno: Baseline and Week 24
|
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 24
|
|
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Časové okno: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease.
The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
Časové okno: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease.
The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
Časové okno: Baseline and Week 24
|
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of child patients suffering from skin disease.
The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Časové okno: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Časové okno: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Časové okno: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the anxiety.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-depression Subscale Score at Week 24
Časové okno: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the depression.
|
Baseline and Week 24
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: MD, Amgen
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Blauvelt A, Deininger KM, Porter J, Sohn A, Qin S, McLeod L, Rylands AJ, Nelson L. Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan 9. doi: 10.1007/s13555-025-01634-5. Online ahead of print.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
20. dubna 2023
Primární dokončení (Aktuální)
Primární dokončení
27. února 2025
Dokončení studie (Aktuální)
Dokončení studie
25. listopadu 2025
Termíny zápisu do studia
První předloženo
První předloženo
20. ledna 2023
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
20. ledna 2023
První zveřejněno (Aktuální)
První zveřejněno
30. ledna 2023
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
28. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. srpna 2026
Naposledy ověřeno
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Genetické choroby, vrozené
- Onemocnění imunitního systému
- Přecitlivělost, okamžitá
- Přecitlivělost
- Kožní choroby
- Kožní onemocnění, genetické
- Kožní onemocnění, ekzematózní
- Dermatitida
- Vrozené, dědičné a neonatální nemoci a abnormality
- Onemocnění kůže a pojivové tkáně
- Dermatitida, atopika
- Nestandardní drogy
- Farmaceutické přípravky
- Padělané drogy
Další identifikační čísla studie
Další identifikační čísla studie
- 20210145
- 2022-501586-50 (Jiný identifikátor: EUCTR)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Ve schválené žádosti o sdílení dat byly odstraněny údaje o jednotlivých pacientech pro proměnné nezbytné k řešení konkrétní výzkumné otázky.
Časový rámec sdílení IPD
Žádosti o sdílení údajů související s touto studií budou zvažovány počínaje 18 měsíci po ukončení studie a buď 1) produktu a indikaci bylo uděleno povolení k uvedení na trh v USA i Evropě, nebo 2) klinický vývoj produktu a/nebo indikace bude ukončen a údaje nebudou předloženy regulačním orgánům.
Neexistuje žádné konečné datum pro způsobilost k odeslání žádosti o sdílení údajů pro tuto studii.
Kritéria přístupu pro sdílení IPD
Kvalifikovaní výzkumní pracovníci mohou předložit žádost obsahující cíle výzkumu, produkt(y) Amgen a studii/studie Amgen v rozsahu, sledované sledované cíle/výsledky, plán statistické analýzy, požadavky na data, plán publikace a kvalifikaci výzkumného pracovníka(ů).
Společnost Amgen obecně neschvaluje externí žádosti o údaje o jednotlivých pacientech za účelem přehodnocení otázek bezpečnosti a účinnosti, které již byly popsány v označení produktu.
Žádosti posuzuje výbor interních poradců.
Pokud nebude schválen, rozhodne nezávislý kontrolní panel sdílení dat a učiní konečné rozhodnutí.
Po schválení budou poskytnuty informace nezbytné k řešení výzkumné otázky za podmínek dohody o sdílení dat.
To může zahrnovat anonymizované údaje o jednotlivých pacientech a/nebo dostupné podpůrné dokumenty obsahující fragmenty kódu analýzy, pokud jsou uvedeny ve specifikacích analýzy.
Další podrobnosti jsou k dispozici na níže uvedené adrese URL.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .