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Eine Studie zur Bewertung von Rocatinlimab (AMG 451) bei Jugendlichen mit mittelschwerer bis schwerer atopischer Dermatitis (AD) (ROCKET-ASTRO)

6. August 2026 aktualisiert von: Amgen

Eine randomisierte, 52-wöchige, placebokontrollierte Doppelblindstudie der Phase 3 mit Rerandomisierung zur Bewertung der Wirksamkeit, Sicherheit und Verträglichkeit von Rocatinlimab (AMG 451) bei jugendlichen Probanden mit mittelschwerer bis schwerer atopischer Dermatitis (AD) ( RAKETE-ASTRO)

Der Zweck dieser Studie ist die Bewertung der Wirksamkeit und Sicherheit von Rocatinlimab in der Monotherapie und Kombinationstherapie bei jugendlichen Probanden.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

532

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Brussels, Belgien, 1070
        • Hopital 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 Clínicas 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
  • 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 Clínicos
  • China
      • Changsha, China, 410007
        • Hunan Childrens Hospital
      • Shenzhen, China, 518038
        • Shenzhen Childrens Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100020
        • Childrens Hospital Capital Institute of Pediatrics
      • Beijing, Beijing Municipality, China, 100044
        • Peking University Peoples Hospital
      • Beijing, Beijing Municipality, China, 100045
        • Beijing Childrens Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400014
        • Childrens Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital Sun-Yat Sen University
    • Henan
      • Nanyang, Henan, China, 473002
        • Nanyang First Peoples Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430014
        • The Central Hospital Of WUHAN
    • Jiangsu
      • Jiangyin, Jiangsu, China, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Bethune Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Dalian Women and Childrens Medical Group
    • Ningxia
      • Yinchuan, Ningxia, China, 750003
        • General Hospital of Ningxia Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200443
        • Shanghai Skin Disease Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610021
        • Chengdu Second Peoples Hospital
      • Suining, Sichuan, China, 629099
        • Suining Central Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650103
        • Kunming Childrens Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310020
        • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
      • Ningbo, Zhejiang, China, 315010
        • Ningbo NO 2 Hospital
      • Taizhou, Zhejiang, China, 318000
        • Taizhou Central Hospital
  • Deutschland
      • Bad Bentheim, Deutschland, 48455
        • Fachklinik Bad Bentheim
      • Bonn, Deutschland, 53127
        • Universitaetsklinikum Bonn
      • Darmstadt, Deutschland, 64283
        • Rosenpark Research GmbH
      • Dresden, Deutschland, 01307
        • Universitaetsklinikum Dresden
      • Erlangen, Deutschland, 91054
        • Universitaetsklinikum Erlangen
      • Frankfurt am Main, Deutschland, 60590
        • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
      • Leipzig, Deutschland, 04103
        • Velocity Clinical Research
      • Mainz, Deutschland, 55101
        • Johannes Gutenberg Universitaet Mainz
  • Frankreich
      • Antony, Frankreich, 92160
        • Hopital Prive d Antony
      • Brest, Frankreich, 29200
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
      • Marseille, Frankreich, 13285
        • Hôpital Saint-Joseph
      • Nantes, Frankreich, 44093
        • Centre Hospitalier Universitaire de Nantes Hôtel Dieu
      • Rennes, Frankreich, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
      • Rouen, Frankreich, 76031
        • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
      • Toulouse, Frankreich, 31059
        • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
  • Griechenland
      • Athens, Griechenland, 11521
        • Athens Naval Hospital
      • Athens, Griechenland, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Athens, Griechenland, 11527
        • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
      • Thessaloniki, Griechenland, 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
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T3K 6B8
        • Rejuvenation Dermatology Laser Calgary North
    • Ontario
      • Markham, Ontario, Kanada, L3P 1X3
        • Lynderm Research Inc
      • Newmarket, Ontario, Kanada, L3Y 5G8
        • Dr SK Siddha Medicine Professional Corporation
      • Niagara Falls, Ontario, Kanada, L2H 1H5
        • Allergy Research Canada Incorporated
      • Windsor, Ontario, Kanada, N8T 1E6
        • XLR8 Medical Research, Incorporated
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 2C1
        • Skinsense Medical Research
  • 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
  • Mexiko
      • Toluca, Mexiko, 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
  • Rumänien
      • Bucharest, Rumänien, 011216
        • Dr Leventer Centre Clinica Dermatologie Bucuresti
      • Cluj-Napoca, Rumänien, 400431
        • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
      • Cluj-Napoca, Rumänien, 400105
        • Derma Cluj
  • Spanien
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Marañon
    • 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
  • Südkorea
      • Ansansi, Gyeonggido, Südkorea, 15355
        • Korea University Ansan Hospital
      • Seoul, Südkorea, 03080
        • Seoul National University Hospital
      • Seoul, Südkorea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Südkorea, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Südkorea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Südkorea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Südkorea, 08308
        • Korea University Guro Hospital
      • Seoul, Südkorea, 06973
        • Chung-Ang University Hospital
      • Seoul, Südkorea, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Südkorea, 04564
        • National Medical Center
      • Seoul, Südkorea, 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
  • 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
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35244
        • Cahaba Dermatology and Skin Health Center
      • Cullman, Alabama, Vereinigte Staaten, 35058
        • AllerVie Clinical Research- Cullman
    • Arizona
      • Tucson, Arizona, Vereinigte Staaten, 85745
        • Eclipse Clinical Research
    • Arkansas
      • North Little Rock, Arkansas, Vereinigte Staaten, 72117
        • Arkansas Research Trials, LLC
    • California
      • Fremont, California, Vereinigte Staaten, 94538
        • Center for Dermatology Clinical Research Inc
      • Fullerton, California, Vereinigte Staaten, 92831
        • Doc1 Healthcare Systems Incorporated
      • Inglewood, California, Vereinigte Staaten, 90301
        • Axon Clinical Research
      • Laguna Niguel, California, Vereinigte Staaten, 92677
        • Avance Clinical Trials
      • Palmdale, California, Vereinigte Staaten, 93551
        • Cura Clinical Research
      • Sacramento, California, Vereinigte Staaten, 95815
        • Integrative Skin Science and Research
      • Sacramento, California, Vereinigte Staaten, 95816
        • University of California at Davis Medical Center
      • San Diego, California, Vereinigte Staaten, 92123
        • Allergy and Asthma Medical Group and Research Center
      • San Diego, California, Vereinigte Staaten, 92123
        • University of California at San Diego Rady Childrens Hospital San Diego
      • Santa Monica, California, Vereinigte Staaten, 90404
        • Clinical Science Institute
      • Sherman Oaks, California, Vereinigte Staaten, 91403
        • Cura Clinical Research Sherman Oaks
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80209
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20010
        • Childrens National Medical Center
    • Florida
      • Brandon, Florida, Vereinigte Staaten, 33511
        • Clinical Research of Brandon
      • Clearwater, Florida, Vereinigte Staaten, 33761
        • Academic Alliance in Dermatology - Saint Petersburg Office
      • Coral Springs, Florida, Vereinigte Staaten, 33071
        • Corazon United States of America, LLC doing business as Life Clinical Trials
      • Delray Beach, Florida, Vereinigte Staaten, 33484
        • Palm Beach Dermatology Group
      • Hialeah, Florida, Vereinigte Staaten, 33012
        • Direct Helpers Research Center
      • Margate, Florida, Vereinigte Staaten, 33063
        • Glick Skin Institute
      • Miami, Florida, Vereinigte Staaten, 33155
        • Miami Clinical Research
      • Miami, Florida, Vereinigte Staaten, 33176
        • ara Professionals Limited Liability Corporation
      • Miami Lakes, Florida, Vereinigte Staaten, 33014
        • Savin Medical Group LLC
      • Miami Lakes, Florida, Vereinigte Staaten, 33016
        • Angels Clinical Research Institute
      • Miami Lakes, Florida, Vereinigte Staaten, 33014
        • Deluxe Health Care LLC
      • Orange City, Florida, Vereinigte Staaten, 32763
        • Optimal Research Sites, LLC
      • Orlando, Florida, Vereinigte Staaten, 32819
        • Clinical Research Investments
      • Orlando, Florida, Vereinigte Staaten, 32819
        • Clinical Associates of Orlando Limited Liability Company
      • Tampa, Florida, Vereinigte Staaten, 33612
        • University of South Florida
    • Georgia
      • Columbus, Georgia, Vereinigte Staaten, 31904
        • Centricity Research Columbus
      • Sandy Springs, Georgia, Vereinigte Staaten, 30328
        • Advanced Medical Research PC
      • Savannah, Georgia, Vereinigte Staaten, 31419
        • Divine Dermatology and Aesthetics
      • Thomasville, Georgia, Vereinigte Staaten, 31792
        • McIntosh Clinic PC
    • Idaho
      • Boise, Idaho, Vereinigte Staaten, 83706-1345
        • Treasure Valley Medical Research
      • Meridian, Idaho, Vereinigte Staaten, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Skokie, Illinois, Vereinigte Staaten, 60077
        • NorthShore University HealthSystem Clinical Trials Center
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • New Albany, Indiana, Vereinigte Staaten, 47150
        • Southern Indiana Clinical Trials
      • Plainfield, Indiana, Vereinigte Staaten, 46168
        • The Indiana Clinical Trials Center PC
    • Kentucky
      • Bowling Green, Kentucky, Vereinigte Staaten, 42104
        • Equity Medical
      • Murray, Kentucky, Vereinigte Staaten, 42071
        • Kentucky Advanced Medical Research LLC
    • Louisiana
      • Monroe, Louisiana, Vereinigte Staaten, 71201
        • Industrial Medicine Associates Clinical Research Advanced Dermatology Care
    • Maryland
      • Rockville, Maryland, Vereinigte Staaten, 20850
        • Aesthetic and Dermatology Center
      • Rockville, Maryland, Vereinigte Staaten, 20850
        • Derm Associates, PC
    • Michigan
      • Auburn Hills, Michigan, Vereinigte Staaten, 48326
        • Oakland Hills Dermatology
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Henry Ford Health System
      • Flint, Michigan, Vereinigte Staaten, 48532
        • Onyx Clinical Research
    • Missouri
      • Saint Joseph, Missouri, Vereinigte Staaten, 64506
        • MediSearch Clinical Trials
      • St Louis, Missouri, Vereinigte Staaten, 63110
        • Saint Louis University
    • Nebraska
      • Lincoln, Nebraska, Vereinigte Staaten, 68505
        • Somnos Clinical Research
    • Nevada
      • Reno, Nevada, Vereinigte Staaten, 89509
        • Skin Cancer and Dermatology Institute
    • New Hampshire
      • Portsmouth, New Hampshire, Vereinigte Staaten, 03801
        • Allcutis Research
    • New Jersey
      • Bridgewater, New Jersey, Vereinigte Staaten, 08807
        • The Dermatology Center of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87102
        • University of New Mexico
    • New York
      • Brooklyn, New York, Vereinigte Staaten, 11211
        • Ace Clinical Trials
      • East Syracuse, New York, Vereinigte Staaten, 13057
        • Empire Dermatology
      • Jackson Heights, New York, Vereinigte Staaten, 11372
        • Smart Medical Research Inc
      • Kew Gardens, New York, Vereinigte Staaten, 11415
        • Forest Hills Dermatology Group
      • New York, New York, Vereinigte Staaten, 10016
        • Pioneer Clinical Research New York
      • New York, New York, Vereinigte Staaten, 10075
        • Cornell University - Weill Cornell Medicine
      • Rochester, New York, Vereinigte Staaten, 14609
        • Rochester Clinical Research
      • The Bronx, New York, Vereinigte Staaten, 10467
        • Yeshiva University - Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27713
        • Duke South Durham
    • Ohio
      • Boardman, Ohio, Vereinigte Staaten, 44512
        • Optima Research
      • Mayfield Heights, Ohio, Vereinigte Staaten, 44124
        • Apex Clinical Research Center LLC
    • Oklahoma
      • Chickasha, Oklahoma, Vereinigte Staaten, 73018
        • Epic Medical Research - Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73120
        • Dermatology and Aesthetics of Oklahoma
      • Tulsa, Oklahoma, Vereinigte Staaten, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Vereinigte Staaten, 74137
        • Essential Medical Research LLC
    • Oregon
      • Grants Pass, Oregon, Vereinigte Staaten, 97527
        • Velocity Clinical Research - Grants Pass
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19103
        • Paddington Testing Company Inc
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten, 02903
        • Rhode Island Hospital, Lifespan
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Medical University of South Carolina
      • North Charleston, South Carolina, Vereinigte Staaten, 29420
        • National Allergy and Asthma Research, LLC
      • Summerville, South Carolina, Vereinigte Staaten, 29486
        • Coastal Pediatric Research
    • Tennessee
      • Morristown, Tennessee, Vereinigte Staaten, 37813
        • HealthStar Physicians Dermatology
    • Texas
      • Bellaire, Texas, Vereinigte Staaten, 77401
        • The University of Texas Health Science Center at Houston
      • Cedar Park, Texas, Vereinigte Staaten, 78613
        • US Dermatology Partners Cedar Park
      • Cypress, Texas, Vereinigte Staaten, 77429
        • Studies in Dermatology LLC
      • Houston, Texas, Vereinigte Staaten, 77037
        • MedCare Pharma - Houston
      • Houston, Texas, Vereinigte Staaten, 77098
        • Tranquil Clinical Research
      • Kerrville, Texas, Vereinigte Staaten, 78028
        • Sante Clinical Research
      • Lubbock, Texas, Vereinigte Staaten, 79424
        • Long and Harris Dermatology
      • Mesquite, Texas, Vereinigte Staaten, 75149
        • Sms Clinical Research Limited Liability Company
      • Missouri City, Texas, Vereinigte Staaten, 77459
        • Sienna Dermatology Research
      • San Antonio, Texas, Vereinigte Staaten, 78218
        • Texas Dermatology and Laser Specialists
      • Southlake, Texas, Vereinigte Staaten, 76092
        • Epiphany Dermatology
      • Sugar Land, Texas, Vereinigte Staaten, 77479
        • Pioneer Research Solutions
    • Utah
      • Murray, Utah, Vereinigte Staaten, 84107
        • Tanner Clinic
      • Providence, Utah, Vereinigte Staaten, 84332
        • Dermatology Research of Utah, dba Providence Dermatology
      • South Jordan, Utah, Vereinigte Staaten, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Franklin, Virginia, Vereinigte Staaten, 23851
        • Maria M Ona MD PC
    • Washington
      • Bellevue, Washington, Vereinigte Staaten, 98007
        • Northwest Clinical Research Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Alter ≥ 12 bis < 18 Jahre an Tag 1.
  • Körpergewicht ≥ 40 kg beim Screening.
  • Anamnestisch unzureichendes Ansprechen auf TCS mittlerer oder höherer Potenz innerhalb von 6 Monaten (mit oder ohne TCI).
  • EASI-Score ≥ 16.
  • vIGA-AD-Score ≥ 3.
  • ≥10 % Körperoberfläche (BSA) der AD-Beteiligung.
  • Schlimmster Pruritus NRS ≥ 4.

Ausschlusskriterien:

  • Behandlung mit einem biologischen Produkt innerhalb von 12 Wochen oder 5 Halbwertszeiten, je nachdem, was länger ist, vor Tag 1.

  • Behandlung mit einem der folgenden Medikamente oder Therapien innerhalb von 4 Wochen oder 5 Halbwertszeiten, je nachdem, was länger ist, vor Tag 1:

    1. Systemische Kortikosteroide
    2. Systemische Immunsuppressiva
    3. Phototherapie
    4. Orale oder topische Januskinase-Inhibitoren

  • Behandlung mit einem der folgenden Medikamente oder Therapien innerhalb von 1 Woche vor Tag 1:

    1. TKS
    2. TZI
    3. Topische Phosphodiesterase-Typ-4-Hemmer
    4. Andere topische Immunsuppressiva

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A: Dosis 1

Teil 1 (Anfangsperiode); Woche 0 bis Woche 24: Rocatinlimab-Dosis 1 alle 4 Wochen (Q4W) für 24 Wochen mit Aufsättigungsdosis in Woche 2 (+ topische Kortikosteroide (TCS)/topischer Calcineurin-Inhibitor (TCI), wenn innerhalb der Kombinationstherapie-Kohorte).

Teil 2 (Wartungszeitraum); Woche 24 bis Woche 52: Teil-1-Responder werden in Woche 24 erneut randomisiert und erhalten Rocatinlimab-Dosis 1 Q4W oder alle 8 Wochen (Q8W) für 28 Wochen (+ TCS/TCI, wenn innerhalb der Kombinationstherapie-Kohorte).
Arzneimittel: Rocatinlimab
Subkutane (SC) Injektion
Andere Namen:
  • AMG 451
Experimental: Arm B: Dosis 2

Teil 1 (Anfangsperiode); Woche 0 bis Woche 24: Rocatinlimab-Dosis 2 Q4W für 24 Wochen mit Aufsättigungsdosis in Woche 2 (+TCS/TCI, wenn innerhalb der Kombinationstherapie-Kohorte).

Teil 2 (Wartungszeitraum); Woche 24 bis Woche 52: Teil-1-Responder werden in Woche 24 erneut randomisiert und erhalten Rocatinlimab-Dosis 2 Q4W oder Q8W für 28 Wochen (mit TCS/TCI, wenn innerhalb der Kombinationstherapie-Kohorte).
Arzneimittel: Rocatinlimab
Subkutane (SC) Injektion
Andere Namen:
  • AMG 451
Experimental: Arm C: Placebo

Teil 1 (Anfangsperiode); Woche 0 bis Woche 24: Placebo Q4W für 24 Wochen mit Aufsättigungsdosis in Woche 2 (+TCS/TCI, wenn innerhalb der Kombinationstherapie-Kohorte).

Teil 2 (Wartungszeitraum); Woche 24 bis Woche 52: Teil-1-Responder werden in Woche 24 mit Placebo Q4W für 28 Wochen neu zugewiesen (mit TCS/TCI, wenn innerhalb der Kombinationstherapie-Kohorte).
Arzneimittel: Placebo
SC-Injektion
Experimental: Arm D: Open-Label-Dosis 1
Teil 2; Woche 24 bis Woche 52: Teil 1 Non-Responder werden in Woche 24 mit Rocatinlimab Open-Label-Dosis 1 Q4W für 28 Wochen neu zugewiesen (mit TCS/TCI, wenn innerhalb der Kombinationstherapie-Kohorte). Teilnehmer in der Erhaltungsphase der Arme A, B oder C werden bei einem Rückfall nach Woche 24 mit der offenen Rocatinlimab-Dosis 1 Q4W (mit TCS/TCI, wenn innerhalb der Kombinationstherapie-Kohorte) neu zugewiesen.
Arzneimittel: Rocatinlimab
Subkutane (SC) Injektion
Andere Namen:
  • AMG 451

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Achieved EASI 75 at Week 16
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Amgen

Ermittler

  • Studienleiter: MD, Amgen

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. April 2023

Primärer Abschluss (Tatsächlich)

27. Februar 2025

Studienabschluss (Tatsächlich)

25. November 2025

Studienanmeldedaten

Zuerst eingereicht

20. Januar 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Januar 2023

Zuerst gepostet (Tatsächlich)

30. Januar 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20210145
  • 2022-501586-50 (Andere Kennung: EUCTR)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Anonymisierte individuelle Patientendaten für Variablen, die zur Beantwortung der spezifischen Forschungsfrage in einem genehmigten Antrag auf gemeinsame Nutzung von Daten erforderlich sind.

IPD-Sharing-Zeitrahmen

Anträge auf gemeinsame Nutzung von Daten im Zusammenhang mit dieser Studie werden ab 18 Monaten nach Abschluss der Studie und entweder 1) dem Produkt und der Indikation eine Marktzulassung in den USA und Europa erteilt wurden oder 2) die klinische Entwicklung für das Produkt und/oder die Indikation eingestellt und die Daten werden nicht an Aufsichtsbehörden übermittelt. Es gibt kein Enddatum für die Berechtigung zur Einreichung eines Antrags auf gemeinsame Nutzung von Daten für diese Studie.

IPD-Sharing-Zugriffskriterien

Qualifizierte Forscher können eine Anfrage einreichen, die die Forschungsziele, das/die Amgen-Produkt(e) und Amgen-Studie(n) im Umfang, Endpunkte/Ergebnisse von Interesse, statistischen Analyseplan, Datenanforderungen, Veröffentlichungsplan und Qualifikationen des/der Forscher(s) enthält. Im Allgemeinen gewährt Amgen keine externen Anfragen nach individuellen Patientendaten zum Zwecke der Neubewertung von Sicherheits- und Wirksamkeitsfragen, die bereits in der Produktkennzeichnung angesprochen wurden. Anträge werden von einem Ausschuss interner Berater geprüft. Wenn dies nicht genehmigt wird, entscheidet ein unabhängiges Prüfgremium für die gemeinsame Nutzung von Daten und trifft die endgültige Entscheidung. Nach der Genehmigung werden die zur Beantwortung der Forschungsfrage erforderlichen Informationen im Rahmen einer Vereinbarung zur gemeinsamen Nutzung von Daten bereitgestellt. Dazu können anonymisierte individuelle Patientendaten und/oder verfügbare unterstützende Dokumente gehören, die Fragmente des Analysecodes enthalten, sofern dies in den Analysespezifikationen vorgesehen ist. Weitere Einzelheiten finden Sie unter der nachstehenden URL.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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