Placebem kontrolovaná, dvojitě zaslepená studie fáze 3 hodnotící monoterapii rocatinlimabem (AMG 451) u středně těžké až těžké atopické dermatitidy (AD) (ROCKET-Horizont) (ROCKET-Horizon)
2. června 2026 aktualizováno: Amgen
Randomizovaná, 24týdenní, placebem kontrolovaná, dvojitě zaslepená studie fáze 3 k posouzení účinnosti, bezpečnosti a snášenlivosti rocatinlimabu (AMG 451) v monoterapii u dospělých pacientů se středně těžkou až těžkou atopickou dermatitidou (AD) (ROCKET- Horizont)
Hlavními cíli studie jsou:
- Vyhodnoťte účinnost rocatinlimabu ve srovnání s placebem v týdnu 24, hodnocenou pomocí Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
- Vyhodnoťte účinnost rocatinlimabu ve srovnání s placebem ve 24. týdnu, hodnocenou pomocí Ekzémové oblasti a indexu závažnosti (EASI).
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
726
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 místa
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New South Wales
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Darlinghurst, New South Wales, Austrálie, 2010
- St George Dermatology and Skin Cancer Centre
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Kogarah, New South Wales, Austrálie, 2217
- Premier Specialists
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Victoria
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Box Hill, Victoria, Austrálie, 3128
- Box Hill Hospital
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Carlton, Victoria, Austrálie, 3053
- Skin Health Institute
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East Melbourne, Victoria, Austrálie, 3002
- Sinclair Dermatology
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Melbourne, Victoria, Austrálie, 3004
- The Alfred Hospital
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Parkville, Victoria, Austrálie, 3050
- The Royal Melbourne Hospital
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Brussels, Belgie, 1070
- Hopital Erasme
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Herstal, Belgie, 4040
- Clinique Andre Renard
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Maldegem, Belgie, 9990
- Dermatologie Maldegem
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Paraná
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Curitiba, Paraná, Brazílie, 80030-110
- CETI - Centro de Estudo em Terapias Inovadoras
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São Paulo
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São Bernardo do Campo, São Paulo, Brazílie, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
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São José dos Campos, São Paulo, Brazílie, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
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Hellerup, Dánsko, 2900
- Gentofte Hospital
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Odense, Dánsko, 5000
- Odense University Hospital
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Tallinn, Estonsko, 13419
- North Estonia Medical Centre
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Tartu, Estonsko, 50106
- Clinical Research Centre
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Helsinki, Finsko, 00180
- CRST Helsinki
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Helsinki, Finsko, 00180
- CRST Turku
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Oulu, Finsko, 90029
- Oulun Yliopistollinen sairaala (OYS)
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Tampere, Finsko, 33100
- Terveystalo Tampere
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Chiba
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Matsudo-shi, Chiba, Japonsko, 271-0092
- Miyata Dermatology Clinic
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Narita-shi, Chiba, Japonsko, 286-8520
- International University of Health and Welfare Narita Hospital
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Hyōgo
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Kobe, Hyōgo, Japonsko, 650-0017
- Kobe University Hospital
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Kanagawa
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Kawasaki-shi, Kanagawa, Japonsko, 216-8511
- St Marianna University Hospital
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Sagamihara-shi, Kanagawa, Japonsko, 252-0392
- National Hospital Organization Sagamihara National Hospital
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Yokohama, Kanagawa, Japonsko, 224-8503
- Showa University Northern Yokohama Hospital
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Nagasaki
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Nagasaki, Nagasaki, Japonsko, 852-8501
- Nagasaki University Hospital
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Osaka
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Habikino-shi, Osaka, Japonsko, 583-8588
- Osaka Habikino Medical Center
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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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Minato-ku, Tokyo, Japonsko, 108-0014
- Mita Dermatology Clinic
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Shinagawa-ku, Tokyo, Japonsko, 142-8666
- Showa University Hospital
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Shinjuku-ku, Tokyo, Japonsko, 161-8521
- Seibo International Catholic Hospital
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Toshima-ku, Tokyo, Japonsko, 170-0002
- Sugamo Kobayashi Derma Clinic
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Toyama
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Takaoka-shi, Toyama, Japonsko, 933-0871
- Shirasaki dermatology clinic
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Durban, Jižní Afrika, 3630
- Hiway Medical Centre
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Gauteng
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Centurion, Gauteng, Jižní Afrika, 0157
- Ryexo Clinical Research
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Johannesburg, Gauteng, Jižní Afrika, 2057
- About Allergy
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Ansansi, Gyeonggido, Jižní Korea, 15355
- Korea University Ansan Hospital
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Bucheon-si, Gyeonggi-do, Jižní Korea, 14584
- Soon Chun Hyang University Bucheon Hospital
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Busan, Jižní Korea, 49241
- Pusan National University Hospital
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Daegu, Jižní Korea, 41944
- Kyungpook National University Hospital
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Gwangju, Jižní Korea, 61453
- Chosun University Hospital
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Incheon, Jižní Korea, 22332
- Inha University Hospital
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Incheon, Jižní Korea, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seongnam-si, Gyeonggi-do, Jižní Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Jižní Korea, 03080
- Seoul National University Hospital
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Seoul, Jižní Korea, 05505
- Asan Medical Center
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Seoul, Jižní Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Jižní Korea, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, Jižní Korea, 02841
- Korea University Anam Hospital
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Seoul, Jižní Korea, 05030
- Konkuk University Medical Center
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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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Seoul, Jižní Korea, 06591
- The Catholic Univ of Korea Seoul St Marys Hospital
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Suwon-si, Gyeonggi-do, Jižní Korea, 16499
- Ajou University Hospital
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Alberta
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Calgary, Alberta, Kanada, T3E 0B2
- Beacon Dermatology
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British Columbia
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Surrey, British Columbia, Kanada, V3R 6A7
- Doctor Chih-Ho Hong Medical Incorporated
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Ontario
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Etobicoke, Ontario, Kanada, M8X 1Y9
- Kingsway Clinical Research
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Markham, Ontario, Kanada, L3P 1X3
- Lynderm Research Inc
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Oakville, Ontario, Kanada, L6J 7W5
- The Centre for Clinical Trials Inc
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Peterborough, Ontario, Kanada, K9J 5K2
- SKiN Centre for Dermatology
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Richmond Hill, Ontario, Kanada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Kanada, M4W 2N4
- Research Toronto
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Windsor, Ontario, Kanada, N8T 1E6
- XLR8 Medical Research, Incorporated
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Quebec
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Québec, Quebec, Kanada, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Sherbrooke, Quebec, Kanada, J1G 1X9
- Clinique Dermatologique de Sherbrooke
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Chihuahua City, Mexiko, 31203
- SCIENTIA Investigacion Clinica SC
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Cuautitlán Izcalli, Mexiko, 54750
- Phylasis Clínicas Research S. De R. L. De C. V.
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Michoacán
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Morelia, Michoacán, Mexiko, 58249
- Clinica de Enfermedades Crónicas y de Procedimientos Especiales
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Bad Bentheim, Německo, 48455
- Fachklinik Bad Bentheim
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Berlin, Německo, 10247
- Hautzentrum Friedrichshain - Dermatologie
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Berlin, Německo, 13672
- Clinical Research Services Berlin GmbH
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Halle, Německo, 06120
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
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Hamburg, Německo, 20354
- Dermatologikum Hamburg
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Kiel, Německo, 24105
- Universitaetsklinikum Schleswig-Holstein
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Leipzig, Německo, 04103
- Velocity Clinical Research
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Münster, Německo, 48149
- Universitaetsklinikum Muenster
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Osnabrück, Německo, 49074
- KliFOs Klinische Forschung Osnabrueck
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Remscheid, Německo, 42897
- Hautarztpraxis Mortazawi
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Wuppertal, Německo, 42283
- Helios Klinikum Wuppertal
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Bialystok, Polsko, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Chorzów, Polsko, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Gdansk, Polsko, 80-214
- Uniwersyteckie Centrum Kliniczne
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Krakow, Polsko, 31-530
- Centermed krakow sp zoo
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Lodz, Polsko, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polsko, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Lodz, Polsko, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin, Polsko, 20-078
- Clinical Best Solutions Sp zoo Spolka komandytowa
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Poznan, Polsko, 61-731
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
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Warsaw, Polsko, 02-625
- Evimed sp zoo centrum medyczne evimed
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Almada, Portugalsko, 2801-951
- Hospital Garcia de Orta, EPE
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Coimbra, Portugalsko, 3000-075
- Centro Hospitalar e Universitário de Coimbra, EPE
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Lisbon, Portugalsko, 1998-018
- Hospital CUF Descobertas
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Porto, Portugalsko, 4099-001
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
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Porto, Portugalsko, 4200-319
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
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Bucharest, Rumunsko, 020125
- Spitalul Clinic Colentina
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Corby, Spojené království, NN17 2UR
- Lakeside Healthcare
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London, Spojené království, SE1 9RT
- Guys Hospital
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Southampton, Spojené království, SO16 6YD
- Southampton General Hospital
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Arizona
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Litchfield Park, Arizona, Spojené státy, 85340
- Research Solutions of Arizona, PC
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Scottsdale, Arizona, Spojené státy, 85260
- Center for Dermatology and Plastic Surgery
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Arkansas
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Fayetteville, Arkansas, Spojené státy, 72703
- Clinical Trials Institute of Northwest Arkansas
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Hot Springs, Arkansas, Spojené státy, 71913
- Burke Pharmaceutical Research
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California
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Chula Vista, California, Spojené státy, 91911
- Velocity Clinical Research Chula Vista
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Dublin, California, Spojené státy, 94568
- West Coast Research LLC
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Encinitas, California, Spojené státy, 92024
- California Dermatology and Clinical Research Institute
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Fremont, California, Spojené státy, 94538
- Center for Dermatology Clinical Research Inc
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La Mesa, California, Spojené státy, 91942
- Velocity Clinical Research - San Diego
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North Hollywood, California, Spojené státy, 91606
- Velocity Clinical Research - North Hollywood
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Palmdale, California, Spojené státy, 93551
- Cura Clinical Research
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San Francisco, California, Spojené státy, 94115
- University of California at San Francisco, Dermatology Clinic at Mount Zion
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Santa Monica, California, Spojené státy, 90404
- Clinical Science Institute
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Colorado
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Castle Rock, Colorado, Spojené státy, 80109
- Clarity Dermatology
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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, 20016
- Foxhall Research Center
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Florida
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Cape Coral, Florida, Spojené státy, 33991
- Renaissance Research and Medical Group
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Coral Gables, Florida, Spojené státy, 33134
- Driven Research LLC
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Doral, Florida, Spojené státy, 33172
- Saint Jude Clinical Research
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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, 33176
- Miami Dade Medical Research Institute, LLC
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Palmetto Bay, Florida, Spojené státy, 33157
- Innovation Medical Research Center Inc
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Tampa, Florida, Spojené státy, 33612
- University of South Florida Health Morsani Center for Advanced Healthcare
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Georgia
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Sandy Springs, Georgia, Spojené státy, 30328
- Advanced Medical Research Pc
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Illinois
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Normal, Illinois, Spojené státy, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
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Indiana
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South Bend, Indiana, Spojené státy, 46617
- The South Bend Clinic LLP
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West Lafayette, Indiana, Spojené státy, 47906
- Options Research Group LLC
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Kansas
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Overland Park, Kansas, Spojené státy, 66223
- Dermatology and Skin Cancer Center of Overland Park
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Kentucky
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Louisville, Kentucky, Spojené státy, 40241
- DS Research
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Murray, Kentucky, Spojené státy, 42071
- Kentucky Advanced Medical Research LLC
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Massachusetts
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Brighton, Massachusetts, Spojené státy, 02135
- MetroBoston Clinical Partners
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Michigan
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Farmington Hills, Michigan, Spojené státy, 48334
- Wendy Sadoff MD Dermatology PC
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Troy, Michigan, Spojené státy, 48084
- Somerset Skin Centre
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Troy, Michigan, Spojené státy, 48084
- Revival Research Institute LLC
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Nebraska
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Omaha, Nebraska, Spojené státy, 68144
- Advanced Dermatology of the Midlands
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Nevada
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Las Vegas, Nevada, Spojené státy, 89117
- James Del Rosso Dermatology Research
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Reno, Nevada, Spojené státy, 89509
- Skin Cancer and Dermatology Institute
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New Hampshire
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Lebanon, New Hampshire, Spojené státy, 03766
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Riverdale, New Jersey, Spojené státy, 07457
- Weiss Medical
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New York
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Horseheads, New York, Spojené státy, 14845
- Corning Center for Clinical Research
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Kew Gardens, New York, Spojené státy, 11415
- Forest Hills Dermatology Group
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Monroe, New York, Spojené státy, 10950
- Crystal Run Healthcare
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New York, New York, Spojené státy, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Spojené státy, 10022
- Ace Clinical Trials
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New York, New York, Spojené státy, 10128
- OptiSkin Medical
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The Bronx, New York, Spojené státy, 10467
- 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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Cincinnati, Ohio, Spojené státy, 45219
- University of Cincinnati
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Cincinnati, Ohio, Spojené státy, 45236
- Bernstein Clinical Research Center LLC
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Gahanna, Ohio, Spojené státy, 43230
- The Ohio State University Dermatology East
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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, 97223
- Oregon Medical Research Center
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Rhode Island
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Warwick, Rhode Island, Spojené státy, 02886
- Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
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Texas
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Bellaire, Texas, Spojené státy, 77401
- Bellaire Dermatology Associates
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Cedar Park, Texas, Spojené státy, 78613
- US Dermatology Partners Cedar Park
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Dallas, Texas, Spojené státy, 75225
- Alina Clinical Trials, LLC
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Dallas, Texas, Spojené státy, 75230
- Zenos Clinical Research, LLC
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Houston, Texas, Spojené státy, 77030
- The University of Texas Health Science Center at Houston
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Houston, Texas, Spojené státy, 77037
- MedCare Pharma - Houston
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Lampasas, Texas, Spojené státy, 76550
- FMCScience LLC
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Lewisville, Texas, Spojené státy, 75057
- Epic Clinical Research Incorporated
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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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San Antonio, Texas, Spojené státy, 78229
- Dermatology Clinical Research Center of San Antonio
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San Antonio, Texas, Spojené státy, 78229
- Andante Research
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Utah
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Murray, Utah, Spojené státy, 84107
- University of Utah Midvalley Dermatology
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Virginia
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Norfolk, Virginia, Spojené státy, 23507
- Eastern Virginia Medical School
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Washington
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Spokane, Washington, Spojené státy, 99202
- MultiCare Institute for Research and Innovation
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Ankara, Turecko (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Gaziantep, Turecko (Türkiye), 27310
- Gaziantep Universitesi Tip Fakultesi Hastanesi
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Istanbul, Turecko (Türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
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Izmir, Turecko (Türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
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Kayseri, Turecko (Türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
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Kocaeli, Turecko (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi Hastanesi
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Sakarya, Turecko (Türkiye), 54050
- Sakarya Egitim ve Arastirma Hastanesi
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Kutná Hora, Česko, 284 01
- Kozni ambulance Kutna Hora sro
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Nový Jičín, Česko, 741 01
- Nemocnice Novy Jicin as
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Pardubice, Česko, 530 02
- CCR Czech as
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Pilsen, Česko, 305 99
- Fakultni Nemocnice Plzen
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Prague, Česko, 130 00
- CCR Prague sro
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Prague, Česko, 120 00
- Dermamedest sro
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Prague, Česko, 106 00
- Kozni ambulance Fialova sro
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Prague, Česko, 150 00
- Praglandia sro
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Svitavy, Česko, 568 02
- Dermatologicka ambulance MUDr Petr Trestik
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Madrid, Španělsko, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Španělsko, 28046
- Hospital Universitario La Paz
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Majadahonda, Španělsko, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Andalusia
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Seville, Andalusia, Španělsko, 41009
- Hospital Universitario Virgen Macarena
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Navarre
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Pamplona, Navarre, Španělsko, 31008
- Clínica Universidad de Navarra
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Valencia
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Alicante, Valencia, Španělsko, 03010
- Hospital General Universitario de Alicante
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Manises, Valencia, Španělsko, 46940
- Hospital de Manises
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Valencia, Valencia, Španělsko, 46015
- Hospital Arnau de Vilanova de Valencia
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Stockholm, Švédsko, 171 76
- Karolinska Universitetssjukhuset Solna
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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
Věk způsobilý ke studiu
18 let až 100 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Věk ≥ 18 let s diagnózou AD podle AAD Consensus Criteria (2014) přítomnou alespoň 6 měsíců
- Anamnéza nedostatečné odpovědi na TCS (topický kortikosteroid) střední nebo vyšší účinnosti během 6 měsíců (s nebo bez topických inhibitorů kalcineurinu [TCI])
- EASI skóre ≥16
- vIGA-AD skóre ≥3
- ≥10 % tělesného povrchu (BSA) postižení AD
- Numerická hodnotící stupnice nejhoršího pruritu ≥ 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
- Inhibitory Janus kinázy
Léčba kterýmkoli z následujících léků nebo terapií během 1 týdne před 1. dnem:
- TCS jakékoli potence
- 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: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Rocatinlimab
Rocatinlimab Dávka 1 každé 4 týdny (Q4W) po dobu 24 týdnů s nasycovací dávkou v týdnu 2.
|
Rocatinlimab bude podáván subkutánní (SC) injekcí.
Ostatní jména:
|
|
Komparátor placeba: Placebo
Placebo Q4W po dobu 24 týdnů s nasycovací dávkou v týdnu 2.
|
Odpovídající placebo bude podáváno SC injekcí.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
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," 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.
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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
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
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 vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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
|
|
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 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.
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 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 ≥ 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 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
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 Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Časové okno: 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
Časové okno: 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
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 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 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
|
|
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 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 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 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 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
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 adult patients suffering from skin disease.
The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
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
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of 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 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
|
|
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
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Časové okno: Baseline and Week 24
|
Weekly 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
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 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
|
|
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 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
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 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
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 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
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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
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.
- 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.
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)
14. prosince 2022
Primární dokončení (Aktuální)
5. června 2024
Dokončení studie (Aktuální)
27. srpna 2024
Termíny zápisu do studia
První předloženo
7. prosince 2022
První předloženo, které splnilo kritéria kontroly kvality
7. prosince 2022
První zveřejněno (Aktuální)
15. prosince 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
26. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. června 2026
Naposledy ověřeno
1. května 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
- Ekzém
- Dermatologická činidla
- KHK4083
Další identifikační čísla studie
- 20210143
- 2022-501538-44 (Jiný identifikátor: EU CT Number)
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 komise 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 .