Uno studio di fase 3, controllato con placebo, in doppio cieco che valuta la monoterapia con rocatinlimab (AMG 451) nella dermatite atopica (AD) da moderata a grave (ROCKET-Horizon) (ROCKET-Horizon)
2 giugno 2026 aggiornato da: Amgen
Uno studio di fase 3, randomizzato, di 24 settimane, controllato con placebo, in doppio cieco per valutare l'efficacia, la sicurezza e la tollerabilità della monoterapia con rocatinlimab (AMG 451) in soggetti adulti con dermatite atopica (AD) da moderata a grave (ROCKET- Orizzonte)
Gli obiettivi co-primari dello studio sono:
- Valutare l'efficacia di rocatinlimab rispetto al placebo alla settimana 24, valutata utilizzando il Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
- Valutare l'efficacia di rocatinlimab rispetto al placebo alla settimana 24, valutata utilizzando l'Eczema Area and Severity Index (EASI).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
726
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New South Wales
-
Darlinghurst, New South Wales, Australia, 2010
- St George Dermatology and Skin Cancer Centre
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Kogarah, New South Wales, Australia, 2217
- Premier Specialists
-
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Victoria
-
Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
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Carlton, Victoria, Australia, 3053
- Skin Health Institute
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East Melbourne, Victoria, Australia, 3002
- Sinclair Dermatology
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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-
-
-
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Brussels, Belgio, 1070
- Hopital Erasme
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Herstal, Belgio, 4040
- Clinique Andre Renard
-
Maldegem, Belgio, 9990
- Dermatologie Maldegem
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-
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Paraná
-
Curitiba, Paraná, Brasile, 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, Brasile, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
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São José dos Campos, São Paulo, Brasile, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
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Alberta
-
Calgary, Alberta, Canada, T3E 0B2
- Beacon Dermatology
-
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British Columbia
-
Surrey, British Columbia, Canada, V3R 6A7
- Doctor Chih-Ho Hong Medical Incorporated
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Ontario
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Etobicoke, Ontario, Canada, M8X 1Y9
- Kingsway Clinical Research
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Markham, Ontario, Canada, L3P 1X3
- Lynderm Research Inc
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Oakville, Ontario, Canada, L6J 7W5
- The Centre for Clinical Trials Inc
-
Peterborough, Ontario, Canada, K9J 5K2
- SKiN Centre for Dermatology
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Richmond Hill, Ontario, Canada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Canada, M4W 2N4
- Research Toronto
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Windsor, Ontario, Canada, N8T 1E6
- XLR8 Medical Research, Incorporated
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Quebec
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Québec, Quebec, Canada, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Sherbrooke, Quebec, Canada, J1G 1X9
- Clinique Dermatologique de Sherbrooke
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-
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Kutná Hora, Cechia, 284 01
- Kozni ambulance Kutna Hora sro
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Nový Jičín, Cechia, 741 01
- Nemocnice Novy Jicin as
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Pardubice, Cechia, 530 02
- CCR Czech as
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Pilsen, Cechia, 305 99
- Fakultni Nemocnice Plzen
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Prague, Cechia, 130 00
- CCR Prague sro
-
Prague, Cechia, 120 00
- Dermamedest sro
-
Prague, Cechia, 106 00
- Kozni ambulance Fialova sro
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Prague, Cechia, 150 00
- Praglandia sro
-
Svitavy, Cechia, 568 02
- Dermatologicka ambulance MUDr Petr Trestik
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-
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Ansansi, Gyeonggido, Corea del Sud, 15355
- Korea University Ansan Hospital
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Bucheon-si, Gyeonggi-do, Corea del Sud, 14584
- Soon Chun Hyang University Bucheon Hospital
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Busan, Corea del Sud, 49241
- Pusan National University Hospital
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Daegu, Corea del Sud, 41944
- Kyungpook National University Hospital
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Gwangju, Corea del Sud, 61453
- Chosun University Hospital
-
Incheon, Corea del Sud, 22332
- Inha University Hospital
-
Incheon, Corea del Sud, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
- Seoul National University Bundang Hospital
-
Seoul, Corea del Sud, 03080
- Seoul National University Hospital
-
Seoul, Corea del Sud, 05505
- Asan Medical Center
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Seoul, Corea del Sud, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Corea del Sud, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, Corea del Sud, 02841
- Korea University Anam Hospital
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Seoul, Corea del Sud, 05030
- Konkuk University Medical Center
-
Seoul, Corea del Sud, 06973
- Chung-Ang University Hospital
-
Seoul, Corea del Sud, 07441
- Hallym University Kangnam Sacred Heart Hospital
-
Seoul, Corea del Sud, 04564
- National Medical Center
-
Seoul, Corea del Sud, 07804
- Ewha Womans University Seoul Hospital
-
Seoul, Corea del Sud, 06591
- The Catholic Univ of Korea Seoul St Marys Hospital
-
Suwon-si, Gyeonggi-do, Corea del Sud, 16499
- Ajou University Hospital
-
-
-
-
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Hellerup, Danimarca, 2900
- Gentofte Hospital
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Odense, Danimarca, 5000
- Odense University Hospital
-
-
-
-
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Tallinn, Estonia, 13419
- North Estonia Medical Centre
-
Tartu, Estonia, 50106
- Clinical Research Centre
-
-
-
-
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Helsinki, Finlandia, 00180
- CRST Helsinki
-
Helsinki, Finlandia, 00180
- CRST Turku
-
Oulu, Finlandia, 90029
- Oulun Yliopistollinen sairaala (OYS)
-
Tampere, Finlandia, 33100
- Terveystalo Tampere
-
-
-
-
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Bad Bentheim, Germania, 48455
- Fachklinik Bad Bentheim
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Berlin, Germania, 10247
- Hautzentrum Friedrichshain - Dermatologie
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Berlin, Germania, 13672
- Clinical Research Services Berlin GmbH
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Halle, Germania, 06120
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
-
Hamburg, Germania, 20354
- Dermatologikum Hamburg
-
Kiel, Germania, 24105
- Universitaetsklinikum Schleswig-Holstein
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Leipzig, Germania, 04103
- Velocity Clinical Research
-
Münster, Germania, 48149
- Universitaetsklinikum Muenster
-
Osnabrück, Germania, 49074
- KliFOs Klinische Forschung Osnabrueck
-
Remscheid, Germania, 42897
- Hautarztpraxis Mortazawi
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Wuppertal, Germania, 42283
- Helios Klinikum Wuppertal
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-
-
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Chiba
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Matsudo-shi, Chiba, Giappone, 271-0092
- Miyata Dermatology Clinic
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Narita-shi, Chiba, Giappone, 286-8520
- International University of Health and Welfare Narita Hospital
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Hyōgo
-
Kobe, Hyōgo, Giappone, 650-0017
- Kobe University Hospital
-
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Kanagawa
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Kawasaki-shi, Kanagawa, Giappone, 216-8511
- St Marianna University Hospital
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Sagamihara-shi, Kanagawa, Giappone, 252-0392
- National Hospital Organization Sagamihara National Hospital
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Yokohama, Kanagawa, Giappone, 224-8503
- Showa University Northern Yokohama Hospital
-
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Nagasaki
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Nagasaki, Nagasaki, Giappone, 852-8501
- Nagasaki University Hospital
-
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Osaka
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Habikino-shi, Osaka, Giappone, 583-8588
- Osaka Habikino Medical Center
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Sakai-shi, Osaka, Giappone, 593-8324
- Dermatology and Ophthalmology Kume Clinic
-
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Shizuoka
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Hamamatsu, Shizuoka, Giappone, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Minato-ku, Tokyo, Giappone, 108-0014
- Mita Dermatology Clinic
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Shinagawa-ku, Tokyo, Giappone, 142-8666
- Showa University Hospital
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Shinjuku-ku, Tokyo, Giappone, 161-8521
- Seibo International Catholic Hospital
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Toshima-ku, Tokyo, Giappone, 170-0002
- Sugamo Kobayashi Derma Clinic
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Toyama
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Takaoka-shi, Toyama, Giappone, 933-0871
- Shirasaki dermatology clinic
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-
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Chihuahua City, Messico, 31203
- SCIENTIA Investigacion Clinica SC
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Cuautitlán Izcalli, Messico, 54750
- Phylasis Clínicas Research S. De R. L. De C. V.
-
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Michoacán
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Morelia, Michoacán, Messico, 58249
- Clinica de Enfermedades Cronicas y de Procedimientos Especiales
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-
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Bialystok, Polonia, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Chorzów, Polonia, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Gdansk, Polonia, 80-214
- Uniwersyteckie Centrum Kliniczne
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Krakow, Polonia, 31-530
- Centermed krakow sp zoo
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Lodz, Polonia, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polonia, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Lodz, Polonia, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin, Polonia, 20-078
- Clinical Best Solutions Sp zoo Spolka komandytowa
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Poznan, Polonia, 61-731
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
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Warsaw, Polonia, 02-625
- Evimed sp zoo centrum medyczne evimed
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-
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-
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Almada, Portogallo, 2801-951
- Hospital Garcia de Orta, EPE
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Coimbra, Portogallo, 3000-075
- Centro Hospitalar e Universitário de Coimbra, EPE
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Lisbon, Portogallo, 1998-018
- Hospital CUF Descobertas
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Porto, Portogallo, 4099-001
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
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Porto, Portogallo, 4200-319
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
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-
-
-
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Corby, Regno Unito, NN17 2UR
- Lakeside Healthcare
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London, Regno Unito, SE1 9RT
- Guys Hospital
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Southampton, Regno Unito, SO16 6YD
- Southampton General Hospital
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-
-
-
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Bucharest, Romania, 020125
- Spitalul Clinic Colentina
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-
-
-
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Madrid, Spagna, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spagna, 28046
- Hospital Universitario La Paz
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Majadahonda, Spagna, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Andalusia
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Seville, Andalusia, Spagna, 41009
- Hospital Universitario Virgen Macarena
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Navarre
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Pamplona, Navarre, Spagna, 31008
- Clinica Universidad de Navarra
-
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Valencia
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Alicante, Valencia, Spagna, 03010
- Hospital General Universitario de Alicante
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Manises, Valencia, Spagna, 46940
- Hospital de Manises
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Valencia, Valencia, Spagna, 46015
- Hospital Arnau de Vilanova de Valencia
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-
-
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Arizona
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Litchfield Park, Arizona, Stati Uniti, 85340
- Research Solutions of Arizona, PC
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Scottsdale, Arizona, Stati Uniti, 85260
- Center for Dermatology and Plastic Surgery
-
-
Arkansas
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Fayetteville, Arkansas, Stati Uniti, 72703
- Clinical Trials Institute of Northwest Arkansas
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Hot Springs, Arkansas, Stati Uniti, 71913
- Burke Pharmaceutical Research
-
-
California
-
Chula Vista, California, Stati Uniti, 91911
- Velocity Clinical Research Chula Vista
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Dublin, California, Stati Uniti, 94568
- West Coast Research LLC
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Encinitas, California, Stati Uniti, 92024
- California Dermatology and Clinical Research Institute
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Fremont, California, Stati Uniti, 94538
- Center for Dermatology Clinical Research Inc
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La Mesa, California, Stati Uniti, 91942
- Velocity Clinical Research - San Diego
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North Hollywood, California, Stati Uniti, 91606
- Velocity Clinical Research - North Hollywood
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Palmdale, California, Stati Uniti, 93551
- Cura Clinical Research
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San Francisco, California, Stati Uniti, 94115
- University of California at San Francisco, Dermatology Clinic at Mount Zion
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Santa Monica, California, Stati Uniti, 90404
- Clinical Science Institute
-
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Colorado
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Castle Rock, Colorado, Stati Uniti, 80109
- Clarity Dermatology
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Denver, Colorado, Stati Uniti, 80209
- Velocity Clinical Research - Denver
-
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20016
- Foxhall Research Center
-
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Florida
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Cape Coral, Florida, Stati Uniti, 33991
- Renaissance Research and Medical Group
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Coral Gables, Florida, Stati Uniti, 33134
- Driven Research LLC
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Doral, Florida, Stati Uniti, 33172
- Saint Jude Clinical Research
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Hialeah, Florida, Stati Uniti, 33012
- Direct Helpers Research Center
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Margate, Florida, Stati Uniti, 33063
- Glick Skin Institute
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Miami, Florida, Stati Uniti, 33176
- Miami Dade Medical Research Institute, LLC
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Palmetto Bay, Florida, Stati Uniti, 33157
- Innovation Medical Research Center Inc
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Tampa, Florida, Stati Uniti, 33612
- University of South Florida Health Morsani Center for Advanced Healthcare
-
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Georgia
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Sandy Springs, Georgia, Stati Uniti, 30328
- Advanced Medical Research Pc
-
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Illinois
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Normal, Illinois, Stati Uniti, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
-
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Indiana
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South Bend, Indiana, Stati Uniti, 46617
- The South Bend Clinic LLP
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West Lafayette, Indiana, Stati Uniti, 47906
- Options Research Group LLC
-
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Kansas
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Overland Park, Kansas, Stati Uniti, 66223
- Dermatology and Skin Cancer Center of Overland Park
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40241
- DS Research
-
Murray, Kentucky, Stati Uniti, 42071
- Kentucky Advanced Medical Research LLC
-
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Massachusetts
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Brighton, Massachusetts, Stati Uniti, 02135
- MetroBoston Clinical Partners
-
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Michigan
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Farmington Hills, Michigan, Stati Uniti, 48334
- Wendy Sadoff MD Dermatology PC
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Troy, Michigan, Stati Uniti, 48084
- Somerset Skin Centre
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Troy, Michigan, Stati Uniti, 48084
- Revival Research Institute LLC
-
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Nebraska
-
Omaha, Nebraska, Stati Uniti, 68144
- Advanced Dermatology of the Midlands
-
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Nevada
-
Las Vegas, Nevada, Stati Uniti, 89117
- James Del Rosso Dermatology Research
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Reno, Nevada, Stati Uniti, 89509
- Skin Cancer and Dermatology Institute
-
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New Hampshire
-
Lebanon, New Hampshire, Stati Uniti, 03766
- Dartmouth-Hitchcock Medical Center
-
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New Jersey
-
Riverdale, New Jersey, Stati Uniti, 07457
- Weiss Medical
-
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New York
-
Horseheads, New York, Stati Uniti, 14845
- Corning Center for Clinical Research
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Kew Gardens, New York, Stati Uniti, 11415
- Forest Hills Dermatology Group
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Monroe, New York, Stati Uniti, 10950
- Crystal Run Healthcare
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New York, New York, Stati Uniti, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Stati Uniti, 10022
- Ace Clinical Trials
-
New York, New York, Stati Uniti, 10128
- OptiSkin Medical
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The Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center
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North Carolina
-
Durham, North Carolina, Stati Uniti, 27713
- Duke South Durham
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- University of Cincinnati
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Cincinnati, Ohio, Stati Uniti, 45236
- Bernstein Clinical Research Center LLC
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Gahanna, Ohio, Stati Uniti, 43230
- The Ohio State University Dermatology East
-
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Oregon
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Grants Pass, Oregon, Stati Uniti, 97527
- Velocity Clinical Research - Grants Pass
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Portland, Oregon, Stati Uniti, 97223
- Oregon Medical Research Center
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Rhode Island
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Warwick, Rhode Island, Stati Uniti, 02886
- Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
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Texas
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Bellaire, Texas, Stati Uniti, 77401
- Bellaire Dermatology Associates
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Cedar Park, Texas, Stati Uniti, 78613
- US Dermatology Partners Cedar Park
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Dallas, Texas, Stati Uniti, 75225
- Alina Clinical Trials, LLC
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Dallas, Texas, Stati Uniti, 75230
- Zenos Clinical Research, LLC
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Houston, Texas, Stati Uniti, 77030
- The University of Texas Health Science Center at Houston
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Houston, Texas, Stati Uniti, 77037
- MedCare Pharma - Houston
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Lampasas, Texas, Stati Uniti, 76550
- FMCScience LLC
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Lewisville, Texas, Stati Uniti, 75057
- Epic Clinical Research Incorporated
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Missouri City, Texas, Stati Uniti, 77459
- Sienna Dermatology Research
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San Antonio, Texas, Stati Uniti, 78218
- Texas Dermatology and Laser Specialists
-
San Antonio, Texas, Stati Uniti, 78229
- Dermatology Clinical Research Center of San Antonio
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San Antonio, Texas, Stati Uniti, 78229
- Andante Research
-
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Utah
-
Murray, Utah, Stati Uniti, 84107
- University of Utah Midvalley Dermatology
-
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Eastern Virginia Medical School
-
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Washington
-
Spokane, Washington, Stati Uniti, 99202
- MultiCare Institute for Research and Innovation
-
-
-
-
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Durban, Sud Africa, 3630
- Hiway Medical Centre
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Gauteng
-
Centurion, Gauteng, Sud Africa, 0157
- Ryexo Clinical Research
-
Johannesburg, Gauteng, Sud Africa, 2057
- About Allergy
-
-
-
-
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Stockholm, Svezia, 171 76
- Karolinska Universitetssjukhuset Solna
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-
-
-
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Ankara, Turchia (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Gaziantep, Turchia (Türkiye), 27310
- Gaziantep Universitesi Tip Fakultesi Hastanesi
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Istanbul, Turchia (Türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
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Izmir, Turchia (Türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
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Kayseri, Turchia (Türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
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Kocaeli, Turchia (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi Hastanesi
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Sakarya, Turchia (Türkiye), 54050
- Sakarya Egitim ve Arastirma Hastanesi
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 100 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Età ≥ 18 anni con diagnosi di AD secondo gli AAD Consensus Criteria (2014) presente da almeno 6 mesi
- Storia di risposta inadeguata a TCS (corticosteroide topico) di potenza media o superiore entro 6 mesi (con o senza inibitori topici della calcineurina [TCI])
- Punteggio EASI ≥16
- Punteggio vIGA-AD ≥3
- ≥10% della superficie corporea (BSA) di coinvolgimento AD
- Scala di valutazione numerica del prurito peggiore ≥ 4
Criteri di esclusione:
- Trattamento con un prodotto biologico entro 12 settimane o 5 emivite, qualunque sia il più lungo, prima del giorno 1
Trattamento con uno qualsiasi dei seguenti farmaci o terapie entro 4 settimane o 5 emivite, qualunque sia il più lungo, prima del Giorno 1:
- Corticosteroidi sistemici
- Immunosoppressori sistemici
- Fototerapia
- Inibitori della Janus chinasi
Trattamento con uno qualsiasi dei seguenti farmaci o terapie entro 1 settimana, prima del Giorno 1:
- TCS di qualsiasi potenza
- TCI
- Inibitori topici della fosfodiesterasi di tipo 4
- Altri agenti immunosoppressori topici
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Rocatinlimab
Rocatinlimab Dose 1 ogni 4 settimane (Q4W) per 24 settimane con una dose di carico alla Settimana 2.
|
Rocatinlimab sarà somministrato attraverso un'iniezione sottocutanea (SC).
Altri nomi:
|
|
Comparatore placebo: Placebo
Placebo Q4W per 24 settimane con una dose di carico alla settimana 2.
|
Il placebo corrispondente verrà somministrato attraverso un'iniezione SC.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: Baseline and Week 24
|
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity.
Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'.
For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?"
If "Yes," the participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, the participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: MD, Amgen
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
14 dicembre 2022
Completamento primario (Effettivo)
5 giugno 2024
Completamento dello studio (Effettivo)
27 agosto 2024
Date di iscrizione allo studio
Primo inviato
7 dicembre 2022
Primo inviato che soddisfa i criteri di controllo qualità
7 dicembre 2022
Primo Inserito (Effettivo)
15 dicembre 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie genetiche, congenite
- Malattie del sistema immunitario
- Ipersensibilità, immediata
- Ipersensibilità
- Malattie della pelle
- Malattie della pelle, genetiche
- Malattie della pelle, eczematose
- Dermatite
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie della pelle e del tessuto connettivo
- Dermatite, atopica
- Eczema
- Agenti dermatologici
- KHK4083
Altri numeri di identificazione dello studio
- 20210143
- 2022-501538-44 (Altro identificatore: EU CT Number)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Dati dei singoli pazienti anonimizzati per le variabili necessarie per affrontare la domanda di ricerca specifica in una richiesta di condivisione dei dati approvata.
Periodo di condivisione IPD
Le richieste di condivisione dei dati relative a questo studio saranno prese in considerazione a partire da 18 mesi dopo la conclusione dello studio e se 1) il prodotto e l'indicazione hanno ottenuto l'autorizzazione all'immissione in commercio sia negli Stati Uniti che in Europa o 2) lo sviluppo clinico per il prodotto e/o l'indicazione viene interrotto e i dati non saranno presentati alle autorità di regolamentazione.
Non esiste una data di fine per l'idoneità a inviare una richiesta di condivisione dei dati per questo studio.
Criteri di accesso alla condivisione IPD
I ricercatori qualificati possono presentare una richiesta contenente gli obiettivi della ricerca, il/i prodotto/i Amgen e lo/gli studio/studi Amgen nell'ambito, gli endpoint/i risultati di interesse, il piano di analisi statistica, i requisiti in materia di dati, il piano di pubblicazione e le qualifiche del/i ricercatore/i.
In generale, Amgen non soddisfa le richieste esterne di dati dei singoli pazienti allo scopo di rivalutare i problemi di sicurezza ed efficacia già affrontati nell'etichettatura del prodotto.
Le richieste vengono esaminate da un comitato di consulenti interni.
In caso di mancata approvazione, un comitato di revisione indipendente sulla condivisione dei dati arbitrerà e prenderà la decisione finale.
Dopo l'approvazione, le informazioni necessarie per affrontare la domanda di ricerca saranno fornite secondo i termini di un accordo di condivisione dei dati.
Ciò può includere dati anonimizzati di singoli pazienti e/o documenti di supporto disponibili, contenenti frammenti di codice di analisi ove previsto nelle specifiche di analisi.
Ulteriori dettagli sono disponibili all'URL sottostante.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .