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En undersøgelse til evaluering af rocatinlimab (AMG 451) hos unge med moderat til svær atopisk dermatitis (AD) (ROCKET-ASTRO)

6. august 2026 opdateret af: Amgen

Et fase 3, randomiseret, 52-ugers, placebokontrolleret, dobbeltblindt studie med genrandomisering for at vurdere effektiviteten, sikkerheden og tolerabiliteten af ​​Rocatinlimab (AMG 451) hos unge forsøgspersoner med moderat til svær atopisk dermatitis (AD) ( ROCKET-ASTRO)

Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af ​​rocatinlimab i monoterapi og kombinationsbehandling hos unge.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

532

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussels, Belgien, 1070
        • Hôpital Erasme
      • Brussels, Belgien, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Ghent, Belgien, 9000
        • Universitair Ziekenhuis Gent
      • Liège, Belgien, 4000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
      • Maldegem, Belgien, 9990
        • Dermatologie Maldegem
  • Brasilien
      • Rio de Janeiro, Brasilien, 20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
    • Espírito Santo
      • Vitória, Espírito Santo, Brasilien, 29055-450
        • Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilien, 41820-020
        • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30575-180
        • Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90020-090
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
    • São Paulo
      • Jaú, São Paulo, Brasilien, 17201-130
        • Cecip Centro Est Clin Int Paulista
      • Ribeirão Preto, São Paulo, Brasilien, 14026-020
        • Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
      • São José do Rio Preto, São Paulo, Brasilien, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo, São Paulo, Brasilien, 01228-200
        • Instituto Pesquisa e Ensino em Saúde Infantil
      • São Paulo, São Paulo, Brasilien, 05403-002
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3K 6B8
        • Rejuvenation Dermatology Laser Calgary North
    • Ontario
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Dr SK Siddha Medicine Professional Corporation
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • Allergy Research Canada Incorporated
      • Windsor, Ontario, Canada, N8T 1E6
        • XLR8 Medical Research, Incorporated
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Skinsense Medical Research
  • Chile
      • Osorno, Chile, 5310644
        • Centro Dermatologico Dermisur
      • Santiago, Chile, 7640881
        • Clinica Dermacross SA
      • Santiago, Chile, 7580206
        • Centro Medico Skinmed Spa
      • Santiago, Chile, 8380465
        • Fundacion Innovacion Cardiovascular
      • Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35244
        • Cahaba Dermatology and Skin Health Center
      • Cullman, Alabama, Forenede Stater, 35058
        • AllerVie Clinical Research- Cullman
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85745
        • Eclipse Clinical Research
    • Arkansas
      • North Little Rock, Arkansas, Forenede Stater, 72117
        • Arkansas Research Trials, LLC
    • California
      • Fremont, California, Forenede Stater, 94538
        • Center for Dermatology Clinical Research Inc
      • Fullerton, California, Forenede Stater, 92831
        • Doc1 Healthcare Systems Incorporated
      • Inglewood, California, Forenede Stater, 90301
        • Axon Clinical Research
      • Laguna Niguel, California, Forenede Stater, 92677
        • Avance Clinical Trials
      • Palmdale, California, Forenede Stater, 93551
        • Cura Clinical Research
      • Sacramento, California, Forenede Stater, 95815
        • Integrative Skin Science and Research
      • Sacramento, California, Forenede Stater, 95816
        • University of California at Davis Medical Center
      • San Diego, California, Forenede Stater, 92123
        • Allergy and Asthma Medical Group and Research Center
      • San Diego, California, Forenede Stater, 92123
        • University of California at San Diego Rady Childrens Hospital San Diego
      • Santa Monica, California, Forenede Stater, 90404
        • Clinical Science Institute
      • Sherman Oaks, California, Forenede Stater, 91403
        • Cura Clinical Research Sherman Oaks
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Childrens National Medical Center
    • Florida
      • Brandon, Florida, Forenede Stater, 33511
        • Clinical Research of Brandon
      • Clearwater, Florida, Forenede Stater, 33761
        • Academic Alliance in Dermatology - Saint Petersburg Office
      • Coral Springs, Florida, Forenede Stater, 33071
        • Corazon United States of America, LLC doing business as Life Clinical Trials
      • Delray Beach, Florida, Forenede Stater, 33484
        • Palm Beach Dermatology Group
      • Hialeah, Florida, Forenede Stater, 33012
        • Direct Helpers Research Center
      • Margate, Florida, Forenede Stater, 33063
        • Glick Skin Institute
      • Miami, Florida, Forenede Stater, 33155
        • Miami Clinical Research
      • Miami, Florida, Forenede Stater, 33176
        • ara Professionals Limited Liability Corporation
      • Miami Lakes, Florida, Forenede Stater, 33014
        • Savin Medical Group LLC
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Angels Clinical Research Institute
      • Miami Lakes, Florida, Forenede Stater, 33014
        • Deluxe Health Care LLC
      • Orange City, Florida, Forenede Stater, 32763
        • Optimal Research Sites, LLC
      • Orlando, Florida, Forenede Stater, 32819
        • Clinical Research Investments
      • Orlando, Florida, Forenede Stater, 32819
        • Clinical Associates of Orlando Limited Liability Company
      • Tampa, Florida, Forenede Stater, 33612
        • University of South Florida
    • Georgia
      • Columbus, Georgia, Forenede Stater, 31904
        • Centricity Research Columbus
      • Sandy Springs, Georgia, Forenede Stater, 30328
        • Advanced Medical Research PC
      • Savannah, Georgia, Forenede Stater, 31419
        • Divine Dermatology and Aesthetics
      • Thomasville, Georgia, Forenede Stater, 31792
        • McIntosh Clinic PC
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706-1345
        • Treasure Valley Medical Research
      • Meridian, Idaho, Forenede Stater, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60077
        • NorthShore University HealthSystem Clinical Trials Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • New Albany, Indiana, Forenede Stater, 47150
        • Southern Indiana Clinical Trials
      • Plainfield, Indiana, Forenede Stater, 46168
        • The Indiana Clinical Trials Center PC
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42104
        • Equity Medical
      • Murray, Kentucky, Forenede Stater, 42071
        • Kentucky Advanced Medical Research LLC
    • Louisiana
      • Monroe, Louisiana, Forenede Stater, 71201
        • Industrial Medicine Associates Clinical Research Advanced Dermatology Care
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20850
        • Aesthetic and Dermatology Center
      • Rockville, Maryland, Forenede Stater, 20850
        • Derm Associates, PC
    • Michigan
      • Auburn Hills, Michigan, Forenede Stater, 48326
        • Oakland Hills Dermatology
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
      • Flint, Michigan, Forenede Stater, 48532
        • Onyx Clinical Research
    • Missouri
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • MediSearch Clinical Trials
      • St Louis, Missouri, Forenede Stater, 63110
        • Saint Louis University
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68505
        • Somnos Clinical Research
    • Nevada
      • Reno, Nevada, Forenede Stater, 89509
        • Skin Cancer and Dermatology Institute
    • New Hampshire
      • Portsmouth, New Hampshire, Forenede Stater, 03801
        • Allcutis Research
    • New Jersey
      • Bridgewater, New Jersey, Forenede Stater, 08807
        • The Dermatology Center of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • University of New Mexico
    • New York
      • Brooklyn, New York, Forenede Stater, 11211
        • Ace Clinical Trials
      • East Syracuse, New York, Forenede Stater, 13057
        • Empire Dermatology
      • Jackson Heights, New York, Forenede Stater, 11372
        • Smart Medical Research Inc
      • Kew Gardens, New York, Forenede Stater, 11415
        • Forest Hills Dermatology Group
      • New York, New York, Forenede Stater, 10016
        • Pioneer Clinical Research New York
      • New York, New York, Forenede Stater, 10075
        • Cornell University - Weill Cornell Medicine
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research
      • The Bronx, New York, Forenede Stater, 10467
        • Yeshiva University - Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27713
        • Duke South Durham
    • Ohio
      • Boardman, Ohio, Forenede Stater, 44512
        • Optima Research
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Apex Clinical Research Center LLC
    • Oklahoma
      • Chickasha, Oklahoma, Forenede Stater, 73018
        • Epic Medical Research - Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Dermatology and Aesthetics of Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Forenede Stater, 74137
        • Essential Medical Research LLC
    • Oregon
      • Grants Pass, Oregon, Forenede Stater, 97527
        • Velocity Clinical Research - Grants Pass
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19103
        • Paddington Testing Company Inc
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital, Lifespan
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29420
        • National Allergy and Asthma Research, LLC
      • Summerville, South Carolina, Forenede Stater, 29486
        • Coastal Pediatric Research
    • Tennessee
      • Morristown, Tennessee, Forenede Stater, 37813
        • HealthStar Physicians Dermatology
    • Texas
      • Bellaire, Texas, Forenede Stater, 77401
        • The University of Texas Health Science Center at Houston
      • Cedar Park, Texas, Forenede Stater, 78613
        • US Dermatology Partners Cedar Park
      • Cypress, Texas, Forenede Stater, 77429
        • Studies in Dermatology LLC
      • Houston, Texas, Forenede Stater, 77037
        • MedCare Pharma - Houston
      • Houston, Texas, Forenede Stater, 77098
        • Tranquil Clinical Research
      • Kerrville, Texas, Forenede Stater, 78028
        • Sante Clinical Research
      • Lubbock, Texas, Forenede Stater, 79424
        • Long and Harris Dermatology
      • Mesquite, Texas, Forenede Stater, 75149
        • Sms Clinical Research Limited Liability Company
      • Missouri City, Texas, Forenede Stater, 77459
        • Sienna Dermatology Research
      • San Antonio, Texas, Forenede Stater, 78218
        • Texas Dermatology and Laser Specialists
      • Southlake, Texas, Forenede Stater, 76092
        • Epiphany Dermatology
      • Sugar Land, Texas, Forenede Stater, 77479
        • Pioneer Research Solutions
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Tanner Clinic
      • Providence, Utah, Forenede Stater, 84332
        • Dermatology Research of Utah, dba Providence Dermatology
      • South Jordan, Utah, Forenede Stater, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Franklin, Virginia, Forenede Stater, 23851
        • Maria M Ona MD PC
    • Washington
      • Bellevue, Washington, Forenede Stater, 98007
        • Northwest Clinical Research Center
  • Frankrig
      • Antony, Frankrig, 92160
        • Hopital Prive d Antony
      • Brest, Frankrig, 29200
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
      • Marseille, Frankrig, 13285
        • Hôpital Saint-Joseph
      • Nantes, Frankrig, 44093
        • Centre Hospitalier Universitaire de Nantes Hôtel Dieu
      • Rennes, Frankrig, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
      • Rouen, Frankrig, 76031
        • Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
      • Toulouse, Frankrig, 31059
        • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
  • Grækenland
      • Athens, Grækenland, 11521
        • Athens Naval Hospital
      • Athens, Grækenland, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Athens, Grækenland, 11527
        • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
      • Thessaloniki, Grækenland, 54643
        • Ippokratio General Hospital of Thessaloniki
  • Israel
      • Bear Sheva, Israel, 8410101
        • Soroka Medical Center
      • Ramat Gan, Israel, 5262000
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center
  • Italien
      • Milan, Italien, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Naples, Italien, 80131
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
      • Perugia, Italien, 06129
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Torino, Italien, 10126
        • Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-0821
        • Central Clinic
    • Chiba
      • Matsudo-shi, Chiba, Japan, 271-0092
        • Miyata Dermatology Clinic
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 819-0373
        • Matsuo Clinic
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-8610
        • Asahikawa City Hospital
      • Obihiro-shi, Hokkaido, Japan, 080-0013
        • Takagi Dermatological Clinic
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan, 674-0068
        • Yoshimura Child Clinic
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0063
        • Katahira Dermatology Urology Clinic
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 231-8682
        • Yokohama city minato Red Cross Hospital
      • Yokohama, Kanagawa, Japan, 221-0825
        • Nomura Dermatology Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-0066
        • Jouzan Hihuka Hinyoukika Clinic
      • Kumamoto, Kumamoto, Japan, 862-0950
        • Suizenji Dermatology Clinic
    • Osaka
      • Neyagawa, Osaka, Japan, 572-0838
        • Yoshioka Dermatology Clinic
      • Sakai-shi, Osaka, Japan, 593-8324
        • Dermatology and Ophthalmology Kume Clinic
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Setagaya-ku, Tokyo, Japan, 158-0097
        • Naoko Dermatology Clinic
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo
  • Kina
      • Changsha, Kina, 410007
        • Hunan Childrens Hospital
      • Shenzhen, Kina, 518038
        • Shenzhen Childrens Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, Kina, 100020
        • Childrens Hospital Capital Institute of Pediatrics
      • Beijing, Beijing Municipality, Kina, 100044
        • Peking University Peoples Hospital
      • Beijing, Beijing Municipality, Kina, 100045
        • Beijing Childrens Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400014
        • Childrens Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510091
        • Dermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, Kina, 510120
        • Sun Yat-sen Memorial Hospital Sun Yat-sen University
      • Guangzhou, Guangdong, Kina, 510080
        • The First Affiliated Hospital Sun-Yat Sen University
    • Henan
      • Nanyang, Henan, Kina, 473002
        • Nanyang First Peoples Hospital
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, Kina, 430014
        • The Central Hospital Of WUHAN
    • Jiangsu
      • Jiangyin, Jiangsu, Kina, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • The First Bethune Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, Kina, 116011
        • Dalian Women and Childrens Medical Group
    • Ningxia
      • Yinchuan, Ningxia, Kina, 750003
        • General Hospital of Ningxia Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200443
        • Shanghai Skin Disease Hospital
    • Sichuan
      • Chengdu, Sichuan, Kina, 610021
        • Chengdu Second Peoples Hospital
      • Suining, Sichuan, Kina, 629099
        • Suining Central Hospital
    • Yunnan
      • Kunming, Yunnan, Kina, 650103
        • Kunming Childrens Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310020
        • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
      • Ningbo, Zhejiang, Kina, 315010
        • Ningbo NO 2 Hospital
      • Taizhou, Zhejiang, Kina, 318000
        • Taizhou Central Hospital
  • Kroatien
      • Ivanić-Grad, Kroatien, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Osijek, Kroatien, 31000
        • University Hospital Centre Osijek
      • Zagreb, Kroatien, 10000
        • University hospital centre Zagreb
      • Zagreb, Kroatien, 10000
        • Sestre milosrdnice University Hospital Center
      • Zagreb, Kroatien, 10000
        • Children s Hospital Zagreb
  • Mexico
      • Toluca, Mexico, 50090
        • Phylasis Clinicas Research Toluca
  • Polen
      • Gdansk, Polen, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk, Polen, 80-280
        • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
      • Katowice, Polen, 40-611
        • Centrum Medyczne Angelius Provita
      • Katowice, Polen, 40-600
        • GynCentrum Sp zoo NZOZ Holsamed
      • Krakow, Polen, 30-002
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
      • Krakow, Polen, 31-559
        • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
      • Lodz, Polen, 90-349
        • AppleTreeClinics Network Spzoo
      • Lodz, Polen, 91-495
        • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
      • Lublin, Polen, 20-011
        • Clinical Best Solutions Sp zoo Spolka komandytowa
      • Sosnowiec, Polen, 41-200
        • Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
      • Tarnów, Polen, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
      • Warsaw, Polen, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Polen, 02-953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Polen, 00-716
        • Klinika Osipowicz and Turkowski Sp zoo
      • Warsaw, Polen, 01-817
        • High Med Przychodnia Specjalistyczna
      • Wroclaw, Polen, 50-450
        • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC
      • San Juan, Puerto Rico, 00909
        • Clinical Research of Puerto Rico
  • Rumænien
      • Bucharest, Rumænien, 011216
        • Dr Leventer Centre Clinica Dermatologie Bucuresti
      • Cluj-Napoca, Rumænien, 400431
        • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
      • Cluj-Napoca, Rumænien, 400105
        • Derma Cluj
  • Spanien
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Marañón
    • Catalonia
      • Barcelona, Catalonia, Spanien, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Esplugues de Llobregat, Catalonia, Spanien, 08950
        • Hospital Sant Joan de Deu
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Clinica Universidad de Navarra
  • Sydkorea
      • Ansansi, Gyeonggido, Sydkorea, 15355
        • Korea University Ansan Hospital
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Sydkorea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Sydkorea, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Sydkorea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Sydkorea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Sydkorea, 08308
        • Korea University Guro Hospital
      • Seoul, Sydkorea, 06973
        • Chung-Ang University Hospital
      • Seoul, Sydkorea, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Sydkorea, 04564
        • National Medical Center
      • Seoul, Sydkorea, 07804
        • Ewha Womans University Seoul Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
      • Pathum Thani, Thailand, 12120
        • Thammasat University Hospital
  • Tyskland
      • Bad Bentheim, Tyskland, 48455
        • Fachklinik Bad Bentheim
      • Bonn, Tyskland, 53127
        • Universitaetsklinikum Bonn
      • Darmstadt, Tyskland, 64283
        • Rosenpark Research GmbH
      • Dresden, Tyskland, 01307
        • Universitaetsklinikum Dresden
      • Erlangen, Tyskland, 91054
        • Universitaetsklinikum Erlangen
      • Frankfurt am Main, Tyskland, 60590
        • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
      • Leipzig, Tyskland, 04103
        • Velocity Clinical Research
      • Mainz, Tyskland, 55101
        • Johannes Gutenberg Universitaet Mainz
  • Ungarn
      • Budapest, Ungarn, 1033
        • Clinexpert Kft
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Ungarn, 4031
        • Derma-B Egeszsegugyi es Szolgaltato Kft
      • Kaposvár, Ungarn, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 17 år (Barn)

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Ingen

Beskrivelse

Inklusionskriterier:

  • Alder ≥ 12 til < 18 år på dag 1.
  • Kropsvægt ≥ 40 kg ved screening.
  • Anamnese med utilstrækkelig respons på TCS af medium eller højere styrke inden for 6 måneder (med eller uden TCI).
  • EASI-score ≥ 16.
  • vIGA-AD-score ≥ 3.
  • ≥10 % kropsoverfladeareal (BSA) af AD-involvering.
  • Værste kløe NRS ≥ 4.

Ekskluderingskriterier:

  • Behandling med et biologisk produkt inden for 12 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1.

  • Behandling med nogen af ​​følgende medikamenter eller terapier inden for 4 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1:

    1. Systemiske kortikosteroider
    2. Systemiske immunsuppressiva
    3. Fototerapi
    4. Orale eller topiske Janus kinasehæmmere

  • Behandling med nogen af ​​følgende medikamenter eller terapier inden for 1 uge før dag 1:

    1. TCS
    2. TCI
    3. Topiske phosphodiesterase type 4-hæmmere
    4. Andre topiske immunsuppressive midler

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A: Dosis 1

Del 1 (Startperiode); Uge 0 til uge 24: Rocatinlimab dosis 1 hver 4. uge (Q4W) i 24 uger med startdosis ved uge 2 (+ topikale kortikosteroider (TCS)/topisk calcineurinhæmmer (TCI), hvis den er i kombinationsterapi-kohorte).

Del 2 (Vedligeholdelsesperiode); Uge 24 til uge 52: Del 1 Responders vil blive rerandomiseret i uge 24 til Rocatinlimab dosis 1 Q4W eller hver 8. uge (Q8W) i 28 uger (+ TCS/TCI hvis inden for kombinationsterapi kohorte).
Medicin: Rocatinlimab
Subkutan (SC) injektion
Andre navne:
  • AMG 451
Eksperimentel: Arm B: Dosis 2

Del 1 (Startperiode); Uge 0 til uge 24: Rocatinlimab dosis 2 Q4W i 24 uger med startdosis ved uge 2 (+TCS/TCI hvis inden for kombinationsterapi kohorte).

Del 2 (Vedligeholdelsesperiode); Uge 24 til uge 52: Del 1-respondanter vil blive rerandomiseret i uge 24 til Rocatinlimab-dosis 2 Q4W eller Q8W i 28 uger (med TCS/TCI, hvis de er i kombinationsterapi-kohorte).
Medicin: Rocatinlimab
Subkutan (SC) injektion
Andre navne:
  • AMG 451
Eksperimentel: Arm C: Placebo

Del 1 (Startperiode); Uge 0 til uge 24: Placebo Q4W i 24 uger med startdosis ved uge 2 (+TCS/TCI hvis inden for kombinationsterapi-kohorte).

Del 2 (Vedligeholdelsesperiode); Uge 24 til uge 52: Del 1-respondenter vil blive gentildelt i uge 24 med placebo Q4W i 28 uger (med TCS/TCI, hvis de er i kombinationsterapi-kohorte).
Medicin: Placebo
SC injektion
Eksperimentel: Arm D: Open-label dosis 1
Del 2; Uge 24 til uge 52: Del 1 ikke-respondere vil blive omplaceret i uge 24 med Rocatinlimab åben dosis 1 Q4W i 28 uger (med TCS/TCI, hvis de er i kombinationsterapi-kohorte). Deltagere i Arm A, B eller C vedligeholdelsesperiode vil blive omplaceret med Rocatinlimab Open-label dosis 1 Q4W (med TCS/TCI hvis inden for kombinationsterapi-kohorte) ved tilbagefald efter uge 24.
Medicin: Rocatinlimab
Subkutan (SC) injektion
Andre navne:
  • AMG 451

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Achieved EASI 75 at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Efterforskere

  • Studieleder: MD, Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. april 2023

Primær færdiggørelse (Faktiske)

27. februar 2025

Studieafslutning (Faktiske)

25. november 2025

Datoer for studieregistrering

Først indsendt

20. januar 2023

Først indsendt, der opfyldte QC-kriterier

20. januar 2023

Først opslået (Faktiske)

30. januar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20210145
  • 2022-501586-50 (Anden identifikator: EUCTR)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Afidentificerede individuelle patientdata for variabler, der er nødvendige for at løse det specifikke forskningsspørgsmål i en godkendt anmodning om datadeling.

IPD-delingstidsramme

Anmodninger om datadeling i forbindelse med denne undersøgelse vil blive overvejet begyndende 18 måneder efter, at undersøgelsen er afsluttet, og enten 1) produktet og indikationen er blevet udstedt markedsføringstilladelse i både USA og Europa eller 2) den kliniske udvikling af produktet og/eller indikationen ophører og dataene vil ikke blive indsendt til de regulerende myndigheder. Der er ingen slutdato for berettigelse til at indsende en anmodning om datadeling for denne undersøgelse.

IPD-delingsadgangskriterier

Kvalificerede forskere kan indsende en anmodning, der indeholder forskningsmålene, Amgen-produktet/-erne og Amgen-undersøgelsen/-undersøgelserne i omfang, endepunkter/resultater af interesse, statistisk analyseplan, datakrav, publikationsplan og forskerens/forskernes kvalifikationer. Generelt imødekommer Amgen ikke eksterne anmodninger om individuelle patientdata med det formål at revurdere sikkerheds- og effektivitetsspørgsmål, der allerede er behandlet i produktmærkningen. Anmodninger gennemgås af et udvalg af interne rådgivere. Hvis den ikke godkendes, vil et uafhængigt datadelingspanel mægle og træffe den endelige beslutning. Efter godkendelse vil oplysninger, der er nødvendige for at løse forskningsspørgsmålet, blive leveret i henhold til vilkårene i en datadelingsaftale. Dette kan omfatte anonymiserede individuelle patientdata og/eller tilgængelige understøttende dokumenter, der indeholder fragmenter af analysekode, hvor det er angivet i analysespecifikationerne. Yderligere detaljer er tilgængelige på URL'en nedenfor.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner