로카틴리맙(AMG 451)을 평가하는 3상 위약 대조 이중 맹검 연구 (ROCKET-Horizon)
2026년 6월 2일 업데이트: Amgen
중등도에서 중증 아토피성 피부염(AD) 성인 대상자를 대상으로 Rocatinlimab(AMG 451) 단일 요법의 효능, 안전성 및 내약성을 평가하기 위한 3상, 무작위, 24주, 위약 대조, 이중 맹검 연구(ROCKET- 수평선)
연구의 공동 주요 목표는 다음과 같습니다.
- vIGA-AD(Validated Investigator's Global Assessment for Atopic Dermatitis)를 사용하여 24주차에 위약과 비교한 로카틴리맙의 효능을 평가합니다.
- 24주차에 Eczema Area and Severity Index(EASI)를 사용하여 rocatinlimab의 효능을 위약과 비교하여 평가합니다.
연구 개요
연구 유형
중재적
등록 (실제)
726
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Durban, 남아프리카, 3630
- Hiway Medical Centre
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Gauteng
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Centurion, Gauteng, 남아프리카, 0157
- Ryexo Clinical Research
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Johannesburg, Gauteng, 남아프리카, 2057
- About Allergy
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Ansansi, Gyeonggido, 대한민국, 15355
- Korea University Ansan Hospital
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Bucheon-si, Gyeonggi-do, 대한민국, 14584
- Soon Chun Hyang University Bucheon Hospital
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Busan, 대한민국, 49241
- Pusan National University Hospital
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Daegu, 대한민국, 41944
- Kyungpook National University Hospital
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Gwangju, 대한민국, 61453
- Chosun University Hospital
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Incheon, 대한민국, 22332
- Inha University Hospital
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Incheon, 대한민국, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seongnam-si, Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, 대한민국, 02841
- Korea University Anam Hospital
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Seoul, 대한민국, 05030
- Konkuk University Medical Center
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Seoul, 대한민국, 06973
- Chung-Ang University Hospital
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Seoul, 대한민국, 07441
- Hallym University Kangnam Sacred Heart Hospital
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Seoul, 대한민국, 04564
- National Medical Center
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Seoul, 대한민국, 07804
- Ewha Womans University Seoul Hospital
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Seoul, 대한민국, 06591
- The Catholic Univ of Korea Seoul St Marys Hospital
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Suwon-si, Gyeonggi-do, 대한민국, 16499
- Ajou University Hospital
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Hellerup, 덴마크, 2900
- Gentofte Hospital
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Odense, 덴마크, 5000
- Odense University Hospital
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Bad Bentheim, 독일, 48455
- Fachklinik Bad Bentheim
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Berlin, 독일, 10247
- Hautzentrum Friedrichshain - Dermatologie
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Berlin, 독일, 13672
- Clinical Research Services Berlin GmbH
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Halle, 독일, 06120
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
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Hamburg, 독일, 20354
- Dermatologikum Hamburg
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Kiel, 독일, 24105
- Universitaetsklinikum Schleswig-Holstein
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Leipzig, 독일, 04103
- Velocity Clinical Research
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Münster, 독일, 48149
- Universitaetsklinikum Muenster
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Osnabrück, 독일, 49074
- KliFOs Klinische Forschung Osnabrueck
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Remscheid, 독일, 42897
- Hautarztpraxis Mortazawi
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Wuppertal, 독일, 42283
- Helios Klinikum Wuppertal
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Bucharest, 루마니아, 020125
- Spitalul Clinic Colentina
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Chihuahua City, 멕시코, 31203
- SCIENTIA Investigacion Clinica SC
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Cuautitlán Izcalli, 멕시코, 54750
- Phylasis Clínicas Research S. De R. L. De C. V.
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Michoacán
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Morelia, Michoacán, 멕시코, 58249
- Clinica de Enfermedades Cronicas y de Procedimientos Especiales
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Arizona
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Litchfield Park, Arizona, 미국, 85340
- Research Solutions of Arizona, PC
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Scottsdale, Arizona, 미국, 85260
- Center for Dermatology and Plastic Surgery
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
- Clinical Trials Institute of Northwest Arkansas
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Hot Springs, Arkansas, 미국, 71913
- Burke Pharmaceutical Research
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California
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Chula Vista, California, 미국, 91911
- Velocity Clinical Research Chula Vista
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Dublin, California, 미국, 94568
- West Coast Research LLC
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Encinitas, California, 미국, 92024
- California Dermatology and Clinical Research Institute
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Fremont, California, 미국, 94538
- Center for Dermatology Clinical Research Inc
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La Mesa, California, 미국, 91942
- Velocity Clinical Research - San Diego
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North Hollywood, California, 미국, 91606
- Velocity Clinical Research - North Hollywood
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Palmdale, California, 미국, 93551
- Cura Clinical Research
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San Francisco, California, 미국, 94115
- University of California at San Francisco, Dermatology Clinic at Mount Zion
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Santa Monica, California, 미국, 90404
- Clinical Science Institute
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Colorado
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Castle Rock, Colorado, 미국, 80109
- Clarity Dermatology
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Denver, Colorado, 미국, 80209
- Velocity Clinical Research - Denver
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20016
- Foxhall Research Center
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Florida
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Cape Coral, Florida, 미국, 33991
- Renaissance Research and Medical Group
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Coral Gables, Florida, 미국, 33134
- Driven Research LLC
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Doral, Florida, 미국, 33172
- Saint Jude Clinical Research
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Hialeah, Florida, 미국, 33012
- Direct Helpers Research Center
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Margate, Florida, 미국, 33063
- Glick Skin Institute
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Miami, Florida, 미국, 33176
- Miami Dade Medical Research Institute, LLC
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Palmetto Bay, Florida, 미국, 33157
- Innovation Medical Research Center Inc
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Tampa, Florida, 미국, 33612
- University of South Florida Health Morsani Center for Advanced Healthcare
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Georgia
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Sandy Springs, Georgia, 미국, 30328
- Advanced Medical Research Pc
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Illinois
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Normal, Illinois, 미국, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
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Indiana
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South Bend, Indiana, 미국, 46617
- The South Bend Clinic LLP
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West Lafayette, Indiana, 미국, 47906
- Options Research Group LLC
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Kansas
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Overland Park, Kansas, 미국, 66223
- Dermatology and Skin Cancer Center of Overland Park
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Kentucky
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Louisville, Kentucky, 미국, 40241
- DS Research
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Murray, Kentucky, 미국, 42071
- Kentucky Advanced Medical Research LLC
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Massachusetts
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Brighton, Massachusetts, 미국, 02135
- MetroBoston Clinical Partners
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Michigan
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Farmington Hills, Michigan, 미국, 48334
- Wendy Sadoff MD Dermatology PC
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Troy, Michigan, 미국, 48084
- Somerset Skin Centre
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Troy, Michigan, 미국, 48084
- Revival Research Institute LLC
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Nebraska
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Omaha, Nebraska, 미국, 68144
- Advanced Dermatology of the Midlands
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Nevada
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Las Vegas, Nevada, 미국, 89117
- James Del Rosso Dermatology Research
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Reno, Nevada, 미국, 89509
- Skin Cancer and Dermatology Institute
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New Hampshire
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Lebanon, New Hampshire, 미국, 03766
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Riverdale, New Jersey, 미국, 07457
- Weiss Medical
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New York
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Horseheads, New York, 미국, 14845
- Corning Center for Clinical Research
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Kew Gardens, New York, 미국, 11415
- Forest Hills Dermatology Group
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Monroe, New York, 미국, 10950
- Crystal Run Healthcare
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, 미국, 10022
- Ace Clinical Trials
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New York, New York, 미국, 10128
- OptiSkin Medical
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The Bronx, New York, 미국, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, 미국, 27713
- Duke South Durham
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Ohio
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Cincinnati, Ohio, 미국, 45219
- University of Cincinnati
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Cincinnati, Ohio, 미국, 45236
- Bernstein Clinical Research Center LLC
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Gahanna, Ohio, 미국, 43230
- The Ohio State University Dermatology East
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Oregon
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Grants Pass, Oregon, 미국, 97527
- Velocity Clinical Research - Grants Pass
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Portland, Oregon, 미국, 97223
- Oregon Medical Research Center
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Rhode Island
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Warwick, Rhode Island, 미국, 02886
- Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
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Texas
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Bellaire, Texas, 미국, 77401
- Bellaire Dermatology Associates
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Cedar Park, Texas, 미국, 78613
- US Dermatology Partners Cedar Park
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Dallas, Texas, 미국, 75225
- Alina Clinical Trials, LLC
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Dallas, Texas, 미국, 75230
- Zenos Clinical Research, LLC
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Houston, Texas, 미국, 77030
- The University of Texas Health Science Center at Houston
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Houston, Texas, 미국, 77037
- MedCare Pharma - Houston
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Lampasas, Texas, 미국, 76550
- FMCScience LLC
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Lewisville, Texas, 미국, 75057
- Epic Clinical Research Incorporated
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Missouri City, Texas, 미국, 77459
- Sienna Dermatology Research
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San Antonio, Texas, 미국, 78218
- Texas Dermatology and Laser Specialists
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San Antonio, Texas, 미국, 78229
- Dermatology Clinical Research Center of San Antonio
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San Antonio, Texas, 미국, 78229
- Andante Research
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Utah
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Murray, Utah, 미국, 84107
- University of Utah Midvalley Dermatology
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Virginia
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Norfolk, Virginia, 미국, 23507
- Eastern Virginia Medical School
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Washington
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Spokane, Washington, 미국, 99202
- MultiCare Institute for Research and Innovation
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Brussels, 벨기에, 1070
- Hopital Erasme
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Herstal, 벨기에, 4040
- Clinique Andre Renard
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Maldegem, 벨기에, 9990
- Dermatologie Maldegem
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Paraná
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Curitiba, Paraná, 브라질, 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, 브라질, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
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São José dos Campos, São Paulo, 브라질, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
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Stockholm, 스웨덴, 171 76
- Karolinska Universitetssjukhuset Solna
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Madrid, 스페인, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Majadahonda, 스페인, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Andalusia
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Seville, Andalusia, 스페인, 41009
- Hospital Universitario Virgen Macarena
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Navarre
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Pamplona, Navarre, 스페인, 31008
- Clinica Universidad de Navarra
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Valencia
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Alicante, Valencia, 스페인, 03010
- Hospital General Universitario de Alicante
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Manises, Valencia, 스페인, 46940
- Hospital de Manises
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Valencia, Valencia, 스페인, 46015
- Hospital Arnau de Vilanova de Valencia
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Tallinn, 에스토니아, 13419
- North Estonia Medical Centre
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Tartu, 에스토니아, 50106
- Clinical Research Centre
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Corby, 영국, NN17 2UR
- Lakeside Healthcare
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London, 영국, SE1 9RT
- Guys Hospital
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Southampton, 영국, SO16 6YD
- Southampton General Hospital
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Chiba
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Matsudo-shi, Chiba, 일본, 271-0092
- Miyata Dermatology Clinic
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Narita-shi, Chiba, 일본, 286-8520
- International University of Health and Welfare Narita Hospital
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Hyōgo
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Kobe, Hyōgo, 일본, 650-0017
- Kobe University Hospital
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Kanagawa
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Kawasaki-shi, Kanagawa, 일본, 216-8511
- St Marianna University Hospital
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Sagamihara-shi, Kanagawa, 일본, 252-0392
- National Hospital Organization Sagamihara National Hospital
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Yokohama, Kanagawa, 일본, 224-8503
- Showa University Northern Yokohama Hospital
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Nagasaki
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Nagasaki, Nagasaki, 일본, 852-8501
- Nagasaki University Hospital
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Osaka
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Habikino-shi, Osaka, 일본, 583-8588
- Osaka Habikino Medical Center
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Sakai-shi, Osaka, 일본, 593-8324
- Dermatology and Ophthalmology Kume Clinic
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Shizuoka
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Hamamatsu, Shizuoka, 일본, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Minato-ku, Tokyo, 일본, 108-0014
- Mita Dermatology Clinic
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Shinagawa-ku, Tokyo, 일본, 142-8666
- Showa University Hospital
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Shinjuku-ku, Tokyo, 일본, 161-8521
- Seibo International Catholic Hospital
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Toshima-ku, Tokyo, 일본, 170-0002
- Sugamo Kobayashi Derma Clinic
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Toyama
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Takaoka-shi, Toyama, 일본, 933-0871
- Shirasaki dermatology clinic
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Kutná Hora, 체코, 284 01
- Kozni ambulance Kutna Hora sro
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Nový Jičín, 체코, 741 01
- Nemocnice Novy Jicin as
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Pardubice, 체코, 530 02
- CCR Czech as
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Pilsen, 체코, 305 99
- Fakultni Nemocnice Plzen
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Prague, 체코, 130 00
- CCR Prague sro
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Prague, 체코, 120 00
- Dermamedest sro
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Prague, 체코, 106 00
- Kozni ambulance Fialova sro
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Prague, 체코, 150 00
- Praglandia sro
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Svitavy, 체코, 568 02
- Dermatologicka ambulance MUDr Petr Trestik
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Alberta
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Calgary, Alberta, 캐나다, T3E 0B2
- Beacon Dermatology
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British Columbia
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Surrey, British Columbia, 캐나다, V3R 6A7
- Doctor Chih-Ho Hong Medical Incorporated
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Ontario
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Etobicoke, Ontario, 캐나다, M8X 1Y9
- Kingsway Clinical Research
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Markham, Ontario, 캐나다, L3P 1X3
- Lynderm Research Inc
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Oakville, Ontario, 캐나다, L6J 7W5
- The Centre for Clinical Trials Inc
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Peterborough, Ontario, 캐나다, K9J 5K2
- SKiN Centre for Dermatology
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Richmond Hill, Ontario, 캐나다, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, 캐나다, M4W 2N4
- Research Toronto
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Windsor, Ontario, 캐나다, N8T 1E6
- XLR8 Medical Research, Incorporated
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Quebec
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Québec, Quebec, 캐나다, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Sherbrooke, Quebec, 캐나다, J1G 1X9
- Clinique Dermatologique de Sherbrooke
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Ankara, 터키 (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Gaziantep, 터키 (Türkiye), 27310
- Gaziantep Universitesi Tip Fakultesi Hastanesi
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Istanbul, 터키 (Türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
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Izmir, 터키 (Türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
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Kayseri, 터키 (Türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
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Kocaeli, 터키 (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi Hastanesi
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Sakarya, 터키 (Türkiye), 54050
- Sakarya Egitim ve Arastirma Hastanesi
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Almada, 포르투갈, 2801-951
- Hospital Garcia de Orta, EPE
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Coimbra, 포르투갈, 3000-075
- Centro Hospitalar e Universitário de Coimbra, EPE
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Lisbon, 포르투갈, 1998-018
- Hospital CUF Descobertas
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Porto, 포르투갈, 4099-001
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
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Porto, 포르투갈, 4200-319
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
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Bialystok, 폴란드, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Chorzów, 폴란드, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Gdansk, 폴란드, 80-214
- Uniwersyteckie Centrum Kliniczne
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Krakow, 폴란드, 31-530
- Centermed krakow sp zoo
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Lodz, 폴란드, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, 폴란드, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Lodz, 폴란드, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin, 폴란드, 20-078
- Clinical Best Solutions Sp zoo Spolka komandytowa
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Poznan, 폴란드, 61-731
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
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Warsaw, 폴란드, 02-625
- Evimed sp zoo centrum medyczne evimed
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Helsinki, 핀란드, 00180
- CRST Helsinki
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Helsinki, 핀란드, 00180
- CRST Turku
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Oulu, 핀란드, 90029
- Oulun Yliopistollinen sairaala (OYS)
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Tampere, 핀란드, 33100
- Terveystalo Tampere
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New South Wales
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Darlinghurst, New South Wales, 호주, 2010
- St George Dermatology and Skin Cancer Centre
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Kogarah, New South Wales, 호주, 2217
- Premier Specialists
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Victoria
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Box Hill, Victoria, 호주, 3128
- Box Hill Hospital
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Carlton, Victoria, 호주, 3053
- Skin Health Institute
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East Melbourne, Victoria, 호주, 3002
- Sinclair Dermatology
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Melbourne, Victoria, 호주, 3004
- The Alfred Hospital
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Parkville, Victoria, 호주, 3050
- The Royal Melbourne Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- AAD 합의 기준(2014)에 따라 AD 진단을 받은 18세 이상의 연령이 최소 6개월 동안 존재
- 6개월 이내에 (국소 칼시뉴린 억제제[TCI]를 사용하거나 사용하지 않고) 중간 또는 더 높은 효능의 TCS(국소 코르티코스테로이드)에 대한 부적절한 반응의 병력
- EASI 점수 ≥16
- vIGA-AD 점수 ≥3
- AD 침범의 ≥10% 체표면적(BSA)
- 최악의 가려움증 수치 등급 척도 ≥ 4
제외 기준:
- 1일 이전에 12주 또는 5 반감기 중 더 긴 기간 내에 생물학적 제제로 치료
1일 이전에 4주 또는 5 반감기 중 더 긴 기간 내에 다음 약물 또는 요법 중 하나로 치료:
- 전신 코르티코스테로이드
- 전신 면역억제제
- 광선 요법
- 야누스 키나제 억제제
1일 전, 1주일 이내에 다음 약물 또는 요법 중 하나로 치료:
- 모든 효능의 TCS
- TCI
- 국소 포스포디에스테라제 4형 억제제
- 기타 국소 면역억제제
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 로카틴리맙
Rocatinlimab 24주 동안 4주마다(Q4W) 용량 1회, 2주차에 부하 용량.
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Rocatinlimab은 피하(SC) 주사를 통해 투여됩니다.
다른 이름들:
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위약 비교기: 위약
2주차에 로딩 용량으로 24주 동안 위약 Q4W.
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일치하는 위약은 SC 주사를 통해 투여됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Baseline and Week 24
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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
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Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Who Achieved EASI 75 at Week 16
기간: 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.
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Baseline and Week 16
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Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (vIGA-AD 0/1) at Week 16
기간: Baseline and Week 16
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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.
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Baseline and Week 16
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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
기간: Baseline and Week 16
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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.
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Baseline and Week 16
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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
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
기간: 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.
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Baseline and Week 24
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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
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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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
기간: 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.
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Baseline and Week 24
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Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
기간: Baseline and Week 16
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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.
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Baseline and Week 16
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
기간: 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.
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Baseline and Week 24
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Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
기간: Baseline and Week 16
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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.
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Baseline and Week 16
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Change From Baseline in SCORAD Itch VAS Score at Week 24
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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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
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in DLQI Score at Week 24
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in POEM Score at Week 24
기간: Baseline and Week 24
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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
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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
기간: Baseline and Week 16
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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
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
기간: 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
|
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
기간: 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
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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
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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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
기간: 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.
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Baseline and Week 16
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Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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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
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in HADS-anxiety Subscale Score at Week 24
기간: Baseline and Week 24
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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
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Change From Baseline in HADS-depression Subscale Score at Week 24
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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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
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: MD, Amgen
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 12월 14일
기본 완료 (실제)
2024년 6월 5일
연구 완료 (실제)
2024년 8월 27일
연구 등록 날짜
최초 제출
2022년 12월 7일
QC 기준을 충족하는 최초 제출
2022년 12월 7일
처음 게시됨 (실제)
2022년 12월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 2일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20210143
- 2022-501538-44 (기타 식별자: EU CT Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
승인된 데이터 공유 요청에서 특정 연구 질문을 해결하는 데 필요한 변수에 대해 식별되지 않은 개별 환자 데이터.
IPD 공유 기간
이 연구와 관련된 데이터 공유 요청은 연구가 종료되고 1) 제품 및 적응증이 미국과 유럽 모두에서 시판 허가를 받았거나 2) 제품 및/또는 적응증에 대한 임상 개발이 중단된 후 18개월부터 고려됩니다. 데이터는 규제 당국에 제출되지 않습니다.
이 연구에 대한 데이터 공유 요청을 제출할 수 있는 자격에 대한 종료 날짜는 없습니다.
IPD 공유 액세스 기준
자격을 갖춘 연구원은 연구 목표, 범위 내 Amgen 제품 및 Amgen 연구/연구, 종점/관심 결과, 통계 분석 계획, 데이터 요구 사항, 출판 계획 및 연구원 자격을 포함하는 요청을 제출할 수 있습니다.
일반적으로 Amgen은 제품 라벨링에서 이미 언급된 안전성 및 효능 문제를 재평가할 목적으로 개별 환자 데이터에 대한 외부 요청을 허용하지 않습니다.
요청은 내부 고문 위원회에서 검토합니다.
승인되지 않은 경우 데이터 공유 독립 검토 패널이 중재하고 최종 결정을 내립니다.
승인되면 연구 질문을 해결하는 데 필요한 정보가 데이터 공유 계약 조건에 따라 제공됩니다.
여기에는 익명화된 개별 환자 데이터 및/또는 분석 사양에 제공된 분석 코드의 일부를 포함하는 사용 가능한 지원 문서가 포함될 수 있습니다.
자세한 내용은 아래 URL에서 확인할 수 있습니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .