중등도에서 중증의 아토피 피부염(AD)이 있는 청소년 피험자에서 Rocatinlimab(AMG 451)을 평가하기 위한 연구 (ROCKET-ASTRO)
2026년 8월 6일 업데이트: Amgen
중등도에서 중증 아토피성 피부염(AD)이 있는 청소년 피험자에서 Rocatinlimab(AMG 451)의 효능, 안전성 및 내약성을 평가하기 위한 3상, 무작위, 52주, 위약 대조, 재무작위화 이중 맹검 연구( 로켓-아스트로)
본 연구의 목적은 청소년을 대상으로 단독요법과 병용요법에서 rocatinlimab의 효능과 안전성을 평가하는 것이다.
연구 개요
연구 유형
중재적
등록 (실제)
532
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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Athens, 그리스, 11521
- Athens Naval Hospital
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Athens, 그리스, 11527
- Thoracic General Hospital Of Athens Sotiria
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Athens, 그리스, 11527
- Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
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Thessaloniki, 그리스, 54643
- Ippokratio General Hospital of Thessaloniki
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-
-
-
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Kaohsiung City, 대만, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, 대만, 10002
- National Taiwan University Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taoyuan, 대만, 33305
- Linkou Chang Gung Memorial Hospital
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-
-
-
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Ansansi, Gyeonggido, 대한민국, 15355
- Korea University Ansan Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 03722
- Severance Hospital Yonsei University Health System
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Seoul, 대한민국, 01830
- Nowon Eulji Medical Center, Eulji University
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Seoul, 대한민국, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, 대한민국, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, 대한민국, 08308
- Korea University Guro Hospital
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Seoul, 대한민국, 06973
- Chung-Ang University Hospital
-
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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Bad Bentheim, 독일, 48455
- Fachklinik Bad Bentheim
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Bonn, 독일, 53127
- Universitaetsklinikum Bonn
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Darmstadt, 독일, 64283
- Rosenpark Research GmbH
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Dresden, 독일, 01307
- Universitaetsklinikum Dresden
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Erlangen, 독일, 91054
- Universitaetsklinikum Erlangen
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Frankfurt am Main, 독일, 60590
- Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
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Leipzig, 독일, 04103
- Velocity Clinical Research
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Mainz, 독일, 55101
- Johannes Gutenberg Universitaet Mainz
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-
-
-
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Bucharest, 루마니아, 011216
- Dr Leventer Centre Clinica Dermatologie Bucuresti
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Cluj-Napoca, 루마니아, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Cluj-Napoca, 루마니아, 400105
- Derma Cluj
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-
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-
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Toluca, 멕시코, 50090
- Phylasis Clinicas Research Toluca
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-
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Alabama
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Birmingham, Alabama, 미국, 35244
- Cahaba Dermatology and Skin Health Center
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Cullman, Alabama, 미국, 35058
- AllerVie Clinical Research- Cullman
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Arizona
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Tucson, Arizona, 미국, 85745
- Eclipse Clinical Research
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Arkansas
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North Little Rock, Arkansas, 미국, 72117
- Arkansas Research Trials, LLC
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California
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Fremont, California, 미국, 94538
- Center for Dermatology Clinical Research Inc
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Fullerton, California, 미국, 92831
- Doc1 Healthcare Systems Incorporated
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Inglewood, California, 미국, 90301
- Axon Clinical Research
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Laguna Niguel, California, 미국, 92677
- Avance Clinical Trials
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Palmdale, California, 미국, 93551
- Cura Clinical Research
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Sacramento, California, 미국, 95815
- Integrative Skin Science and Research
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Sacramento, California, 미국, 95816
- University of California at Davis Medical Center
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San Diego, California, 미국, 92123
- Allergy and Asthma Medical Group and Research Center
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San Diego, California, 미국, 92123
- University of California at San Diego Rady Childrens Hospital San Diego
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Santa Monica, California, 미국, 90404
- Clinical Science Institute
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Sherman Oaks, California, 미국, 91403
- Cura Clinical Research Sherman Oaks
-
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Colorado
-
Denver, Colorado, 미국, 80209
- Velocity Clinical Research - Denver
-
-
District of Columbia
-
Washington D.C., District of Columbia, 미국, 20010
- Childrens National Medical Center
-
-
Florida
-
Brandon, Florida, 미국, 33511
- Clinical Research of Brandon
-
Clearwater, Florida, 미국, 33761
- Academic Alliance in Dermatology - Saint Petersburg Office
-
Coral Springs, Florida, 미국, 33071
- Corazon United States of America, LLC doing business as Life Clinical Trials
-
Delray Beach, Florida, 미국, 33484
- Palm Beach Dermatology Group
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Hialeah, Florida, 미국, 33012
- Direct Helpers Research Center
-
Margate, Florida, 미국, 33063
- Glick Skin Institute
-
Miami, Florida, 미국, 33155
- Miami Clinical Research
-
Miami, Florida, 미국, 33176
- ara Professionals Limited Liability Corporation
-
Miami Lakes, Florida, 미국, 33014
- Savin Medical Group LLC
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Miami Lakes, Florida, 미국, 33016
- Angels Clinical Research Institute
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Miami Lakes, Florida, 미국, 33014
- Deluxe Health Care LLC
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Orange City, Florida, 미국, 32763
- Optimal Research Sites, LLC
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Orlando, Florida, 미국, 32819
- Clinical Research Investments
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Orlando, Florida, 미국, 32819
- Clinical Associates of Orlando Limited Liability Company
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Tampa, Florida, 미국, 33612
- University of South Florida
-
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Georgia
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Columbus, Georgia, 미국, 31904
- Centricity Research Columbus
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Sandy Springs, Georgia, 미국, 30328
- Advanced Medical Research Pc
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Savannah, Georgia, 미국, 31419
- Divine Dermatology and Aesthetics
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Thomasville, Georgia, 미국, 31792
- McIntosh Clinic PC
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Idaho
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Boise, Idaho, 미국, 83706-1345
- Treasure Valley Medical Research
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Meridian, Idaho, 미국, 83642
- Velocity Clinical Research - Boise
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Illinois
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Skokie, Illinois, 미국, 60077
- NorthShore University HealthSystem Clinical Trials Center
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Indiana
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Indianapolis, Indiana, 미국, 46250
- Dawes Fretzin Clinical Research Group, LLC
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New Albany, Indiana, 미국, 47150
- Southern Indiana Clinical Trials
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Plainfield, Indiana, 미국, 46168
- The Indiana Clinical Trials Center PC
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Kentucky
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Bowling Green, Kentucky, 미국, 42104
- Equity Medical
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Murray, Kentucky, 미국, 42071
- Kentucky Advanced Medical Research LLC
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Louisiana
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Monroe, Louisiana, 미국, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, 미국, 20850
- Aesthetic and Dermatology Center
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Rockville, Maryland, 미국, 20850
- Derm Associates, PC
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Michigan
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Auburn Hills, Michigan, 미국, 48326
- Oakland Hills Dermatology
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Detroit, Michigan, 미국, 48202
- Henry Ford Health System
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Flint, Michigan, 미국, 48532
- Onyx Clinical Research
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Missouri
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Saint Joseph, Missouri, 미국, 64506
- MediSearch Clinical Trials
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St Louis, Missouri, 미국, 63110
- Saint Louis University
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Nebraska
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Lincoln, Nebraska, 미국, 68505
- Somnos Clinical Research
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Nevada
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Reno, Nevada, 미국, 89509
- Skin Cancer and Dermatology Institute
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New Hampshire
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Portsmouth, New Hampshire, 미국, 03801
- Allcutis Research
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New Jersey
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Bridgewater, New Jersey, 미국, 08807
- The Dermatology Center of New Jersey
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
- University of New Mexico
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New York
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Brooklyn, New York, 미국, 11211
- Ace Clinical Trials
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East Syracuse, New York, 미국, 13057
- Empire Dermatology
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Jackson Heights, New York, 미국, 11372
- Smart Medical Research Inc
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Kew Gardens, New York, 미국, 11415
- Forest Hills Dermatology Group
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New York, New York, 미국, 10016
- Pioneer Clinical Research New York
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New York, New York, 미국, 10075
- Cornell University - Weill Cornell Medicine
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Rochester, New York, 미국, 14609
- Rochester Clinical Research
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The Bronx, New York, 미국, 10467
- Yeshiva University - 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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Boardman, Ohio, 미국, 44512
- Optima Research
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Mayfield Heights, Ohio, 미국, 44124
- Apex Clinical Research Center LLC
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Oklahoma
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Chickasha, Oklahoma, 미국, 73018
- Epic Medical Research - Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- Lynn Health Science Institute
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Oklahoma City, Oklahoma, 미국, 73120
- Dermatology and Aesthetics of Oklahoma
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Tulsa, Oklahoma, 미국, 74132
- Dermatology Research Center of Oklahoma, PLLC
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Tulsa, Oklahoma, 미국, 74137
- Essential Medical Research LLC
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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, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19103
- Paddington Testing Company Inc
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital, Lifespan
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina
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North Charleston, South Carolina, 미국, 29420
- National Allergy and Asthma Research, LLC
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Summerville, South Carolina, 미국, 29486
- Coastal Pediatric Research
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Tennessee
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Morristown, Tennessee, 미국, 37813
- HealthStar Physicians Dermatology
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Texas
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Bellaire, Texas, 미국, 77401
- The University of Texas Health Science Center at Houston
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Cedar Park, Texas, 미국, 78613
- US Dermatology Partners Cedar Park
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Cypress, Texas, 미국, 77429
- Studies in Dermatology LLC
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Houston, Texas, 미국, 77037
- MedCare Pharma - Houston
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Houston, Texas, 미국, 77098
- Tranquil Clinical Research
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Kerrville, Texas, 미국, 78028
- Sante Clinical Research
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Lubbock, Texas, 미국, 79424
- Long and Harris Dermatology
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Mesquite, Texas, 미국, 75149
- Sms Clinical Research Limited Liability Company
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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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Southlake, Texas, 미국, 76092
- Epiphany Dermatology
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Sugar Land, Texas, 미국, 77479
- Pioneer Research Solutions
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Utah
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Murray, Utah, 미국, 84107
- Tanner Clinic
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Providence, Utah, 미국, 84332
- Dermatology Research of Utah, dba Providence Dermatology
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South Jordan, Utah, 미국, 84095
- Jordan Valley Dermatology Center
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Virginia
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Franklin, Virginia, 미국, 23851
- Maria M Ona MD PC
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Washington
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Bellevue, Washington, 미국, 98007
- Northwest Clinical Research Center
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Brussels, 벨기에, 1070
- Hopital Erasme
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Brussels, 벨기에, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, 벨기에, 9000
- Universitair Ziekenhuis Gent
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Liège, 벨기에, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Maldegem, 벨기에, 9990
- Dermatologie Maldegem
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Rio de Janeiro, 브라질, 20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
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Espírito Santo
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Vitória, Espírito Santo, 브라질, 29055-450
- Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
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Estado de Bahia
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Salvador, Estado de Bahia, 브라질, 41820-020
- Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
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Minas Gerais
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Belo Horizonte, Minas Gerais, 브라질, 30575-180
- Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, 브라질, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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São Paulo
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Jaú, São Paulo, 브라질, 17201-130
- Cecip Centro Est Clin Int Paulista
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Ribeirão Preto, São Paulo, 브라질, 14026-020
- Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
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São José do Rio Preto, São Paulo, 브라질, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, 브라질, 01228-200
- Instituto Pesquisa e Ensino em Saúde Infantil
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São Paulo, São Paulo, 브라질, 05403-002
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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-
-
-
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Marañón
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Catalonia
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Barcelona, Catalonia, 스페인, 08041
- Hospital de La Santa Creu i Sant Pau
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Esplugues de Llobregat, Catalonia, 스페인, 08950
- Hospital Sant Joan de Déu
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Navarre
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Pamplona, Navarre, 스페인, 31008
- Clinica Universidad de Navarra
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-
-
-
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Bear Sheva, 이스라엘, 8410101
- Soroka Medical Center
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Ramat Gan, 이스라엘, 5262000
- Sheba medical center
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Tel Aviv, 이스라엘, 6423906
- Sourasky Medical Center
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-
-
-
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Milan, 이탈리아, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Naples, 이탈리아, 80131
- Azienda Ospedaliera Universitaria Luigi Vanvitelli
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Perugia, 이탈리아, 06129
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
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Torino, 이탈리아, 10126
- Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
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-
-
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Aichi-ken
-
Nagoya, Aichi-ken, 일본, 464-0821
- Central Clinic
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Chiba
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Matsudo-shi, Chiba, 일본, 271-0092
- Miyata Dermatology Clinic
-
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Fukuoka
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Fukuoka, Fukuoka, 일본, 819-0373
- Matsuo Clinic
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Hokkaido
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Asahikawa-shi, Hokkaido, 일본, 070-8610
- Asahikawa City Hospital
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Obihiro-shi, Hokkaido, 일본, 080-0013
- Takagi Dermatological Clinic
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Hyōgo
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Akashi-shi, Hyōgo, 일본, 674-0068
- Yoshimura Child Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, 일본, 890-0063
- Katahira Dermatology Urology Clinic
-
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Kanagawa
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Yokohama, Kanagawa, 일본, 231-8682
- Yokohama City Minato Red Cross Hospital
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Yokohama, Kanagawa, 일본, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, 일본, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, 일본, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, 일본, 572-0838
- Yoshioka Dermatology Clinic
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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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Setagaya-ku, Tokyo, 일본, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, 일본, 141-8625
- NTT Medical Center Tokyo
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-
-
-
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Changsha, 중국, 410007
- Hunan Childrens Hospital
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Shenzhen, 중국, 518038
- Shenzhen Childrens Hospital
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-
Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, 중국, 100020
- Childrens Hospital Capital Institute of Pediatrics
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Beijing, Beijing Municipality, 중국, 100044
- Peking University Peoples Hospital
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Beijing, Beijing Municipality, 중국, 100045
- Beijing Childrens Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, 중국, 400014
- Childrens Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, 중국, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, 중국, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, 중국, 510080
- The First Affiliated Hospital Sun-Yat Sen University
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Henan
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Nanyang, Henan, 중국, 473002
- Nanyang First Peoples Hospital
-
-
Hubei
-
Wuhan, Hubei, 중국, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Wuhan, Hubei, 중국, 430014
- The Central Hospital of Wuhan
-
-
Jiangsu
-
Jiangyin, Jiangsu, 중국, 214400
- Jiangyin Hospital of Traditional Chinese Medicine
-
-
Jilin
-
Changchun, Jilin, 중국, 130021
- The First Bethune Hospital of Jilin University
-
-
Liaoning
-
Dalian, Liaoning, 중국, 116011
- Dalian Women and Childrens Medical Group
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-
Ningxia
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Yinchuan, Ningxia, 중국, 750003
- General Hospital of Ningxia Medical University
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-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 200443
- Shanghai Skin Disease Hospital
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-
Sichuan
-
Chengdu, Sichuan, 중국, 610021
- Chengdu Second Peoples Hospital
-
Suining, Sichuan, 중국, 629099
- Suining Central Hospital
-
-
Yunnan
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Kunming, Yunnan, 중국, 650103
- Kunming Childrens Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310020
- Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
-
Ningbo, Zhejiang, 중국, 315010
- Ningbo NO 2 Hospital
-
Taizhou, Zhejiang, 중국, 318000
- Taizhou Central Hospital
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-
-
-
-
Osorno, 칠레, 5310644
- Centro Dermatologico Dermisur
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Santiago, 칠레, 7640881
- Clinica Dermacross SA
-
Santiago, 칠레, 7580206
- Centro Medico Skinmed Spa
-
Santiago, 칠레, 8380465
- Fundacion Innovacion Cardiovascular
-
Santiago, 칠레, 8420383
- Centro Internacional de Estudios Clínicos
-
-
-
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Alberta
-
Calgary, Alberta, 캐나다, T3K 6B8
- Rejuvenation Dermatology Laser Calgary North
-
-
Ontario
-
Markham, Ontario, 캐나다, L3P 1X3
- Lynderm Research Inc
-
Newmarket, Ontario, 캐나다, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, 캐나다, L2H 1H5
- Allergy Research Canada Incorporated
-
Windsor, Ontario, 캐나다, N8T 1E6
- XLR8 Medical Research, Incorporated
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, 캐나다, S7K 2C1
- Skinsense Medical Research
-
-
-
-
-
Ivanić-Grad, 크로아티아, 10310
- Special Hospital for Medical Rehabilitation Naftalan
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Osijek, 크로아티아, 31000
- University Hospital Centre Osijek
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Zagreb, 크로아티아, 10000
- University Hospital Centre Zagreb
-
Zagreb, 크로아티아, 10000
- Sestre milosrdnice University Hospital Center
-
Zagreb, 크로아티아, 10000
- Children s Hospital Zagreb
-
-
-
-
-
Bangkok, 태국, 10330
- King Chulalongkorn Memorial Hospital
-
Bangkok, 태국, 10700
- Siriraj Hospital
-
Chiang Mai, 태국, 50200
- Maharaj Nakorn Chiang Mai Hospital
-
Pathum Thani, 태국, 12120
- Thammasat University Hospital
-
-
-
-
-
Gdansk, 폴란드, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Gdansk, 폴란드, 80-280
- AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
-
Katowice, 폴란드, 40-611
- Centrum Medyczne Angelius Provita
-
Katowice, 폴란드, 40-600
- GynCentrum Sp zoo NZOZ Holsamed
-
Krakow, 폴란드, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
-
Krakow, 폴란드, 31-559
- Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
-
Lodz, 폴란드, 90-349
- AppleTreeClinics Network Spzoo
-
Lodz, 폴란드, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
-
Lublin, 폴란드, 20-011
- Clinical Best Solutions Sp zoo Spolka komandytowa
-
Sosnowiec, 폴란드, 41-200
- Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
-
Tarnów, 폴란드, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
-
Warsaw, 폴란드, 02-962
- Royalderm Agnieszka Nawrocka
-
Warsaw, 폴란드, 02-953
- Klinika Ambroziak Dermatologia
-
Warsaw, 폴란드, 00-716
- Klinika Osipowicz and Turkowski Sp zoo
-
Warsaw, 폴란드, 01-817
- High Med Przychodnia Specjalistyczna
-
Wroclaw, 폴란드, 50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
-
-
-
-
-
San Juan, 푸에르토 리코, 00917
- GCM Medical Group, PSC
-
San Juan, 푸에르토 리코, 00909
- Clinical Research of Puerto Rico
-
-
-
-
-
Antony, 프랑스, 92160
- Hopital Prive d Antony
-
Brest, 프랑스, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
-
Marseille, 프랑스, 13285
- Hôpital Saint-Joseph
-
Nantes, 프랑스, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
-
Rennes, 프랑스, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, 프랑스, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
-
Toulouse, 프랑스, 31059
- Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
-
-
-
-
-
Budapest, 헝가리, 1033
- Clinexpert Kft
-
Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Debrecen, 헝가리, 4031
- Derma-B Egeszsegugyi es Szolgaltato Kft
-
Kaposvár, 헝가리, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
-
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
12년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 1일차에 ≥ 12~< 18세.
- 스크리닝 시 체중 ≥ 40kg.
- 6개월 이내에 중간 또는 더 높은 효능의 TCS에 대한 부적절한 반응의 이력(TCI 유무에 관계없이).
- EASI 점수 ≥ 16.
- vIGA-AD 점수 ≥ 3.
- AD 침범의 ≥10% 체표면적(BSA).
- 최악의 가려움증 NRS ≥ 4.
제외 기준:
- 1일 이전에 12주 또는 5 반감기 중 더 긴 기간 이내에 생물학적 제품을 사용한 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
- 경구 또는 국소 야누스 키나제 억제제
1일 전, 1주일 이내에 다음 약물 또는 요법 중 하나로 치료:
- 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: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: A군: 용량 1
파트 1(초기 기간) 0주차 ~ 24주차: 2주차에 부하 용량을 포함하여 24주 동안 4주마다(Q4W) Rocatinlimab 용량 1(+ 병용 요법 코호트인 경우 국소 코르티코스테로이드(TCS)/국소 칼시뉴린 억제제(TCI)). 파트 2(유지보수 기간) 24주차 ~ 52주차: 파트 1 반응자는 24주차에 Rocatinlimab 용량 1 Q4W 또는 28주 동안 8주마다(Q8W)(병용 요법 코호트에 있는 경우 + TCS/TCI) 재배열됩니다. |
피하(SC) 주사
다른 이름들:
|
|
실험적: 팔 B: 복용량 2
파트 1(초기 기간) 0주차 ~ 24주차: 2주차에 부하 용량과 함께 24주 동안 Rocatinlimab 용량 2 Q4W(병용 요법 코호트 내에 있는 경우 +TCS/TCI). 파트 2(유지보수 기간) 24주차 ~ 52주차: 파트 1 응답자는 24주차에 28주 동안 Rocatinlimab 용량 2 Q4W 또는 Q8W로 재배열됩니다(병용 요법 코호트 내에 있는 경우 TCS/TCI 포함). |
피하(SC) 주사
다른 이름들:
|
|
실험적: C군: 위약
파트 1(초기 기간) 0주차부터 24주차까지: 2주차에 부하 용량으로 24주 동안 위약 Q4W(병용 요법 코호트 내에 있는 경우 +TCS/TCI). 파트 2(유지보수 기간) 24주차 ~ 52주차: 파트 1 반응자는 28주 동안 위약 Q4W로 24주차에 재배정됩니다(병용 요법 코호트 내에 있는 경우 TCS/TCI와 함께). |
SC 주입
|
|
실험적: D군: 라벨 공개 용량 1
2 부; 24주차 ~ 52주차: 파트 1 비반응자는 28주 동안 Rocatinlimab 공개 라벨 용량 1 Q4W로 24주차에 재배정됩니다(병용 요법 코호트 내에 있는 경우 TCS/TCI 포함).
A, B 또는 C군 유지 기간의 참가자는 24주 후 재발 시 Rocatinlimab 공개 라벨 용량 1 Q4W(병용 요법 코호트에 있는 경우 TCS/TCI 포함)로 재배정됩니다.
|
피하(SC) 주사
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
기간: Baseline and Week 24
|
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity.
Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'.
For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?"
If "Yes," participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved EASI 75 at Week 24
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
|
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
기간: Baseline and Week 16
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
기간: Baseline and Week 24
|
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
기간: 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
기간: Baseline and Week 24
|
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
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
|
|
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
|
|
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
|
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
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.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
기간: Baseline and Week 24
|
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data.
SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
기간: Baseline and Week 16
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
기간: Baseline and Week 16
|
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 16
|
|
Change From Baseline in SCORAD Itch VAS Score at Week 24
기간: Baseline and Week 24
|
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
기간: Baseline and Week 24
|
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours.
Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance.
Participants were asked to rate the intensity of their sleep disturbance using this scale each day.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in level of sleep disturbance.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
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.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved 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.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
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.
Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
기간: Baseline and Week 24
|
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
기간: Up to Week 16
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 16
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
기간: Up to Week 24
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 24
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
기간: Baseline and Week 16
|
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 16
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
기간: Baseline and Week 24
|
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 24
|
|
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
기간: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease.
The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
기간: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease.
The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
기간: Baseline and Week 24
|
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of child patients suffering from skin disease.
The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
기간: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
기간: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-anxiety Subscale Score at Week 24
기간: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the anxiety.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-depression Subscale Score at Week 24
기간: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the depression.
|
Baseline and Week 24
|
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.
- Blauvelt A, Deininger KM, Porter J, Sohn A, Qin S, McLeod L, Rylands AJ, Nelson L. Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan 9. doi: 10.1007/s13555-025-01634-5. Online ahead of print.
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)
2023년 4월 20일
기본 완료 (실제)
2025년 2월 27일
연구 완료 (실제)
2025년 11월 25일
연구 등록 날짜
최초 제출
2023년 1월 20일
QC 기준을 충족하는 최초 제출
2023년 1월 20일
처음 게시됨 (실제)
2023년 1월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 6일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20210145
- 2022-501586-50 (기타 식별자: EUCTR)
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. .