Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie for å evaluere Rocatinlimab (AMG 451) hos ungdommer med moderat til alvorlig atopisk dermatitt (AD) (ROCKET-ASTRO)

6. august 2026 oppdatert av: Amgen

En fase 3, randomisert, 52-ukers, placebokontrollert, dobbeltblind studie med rerandomisering for å vurdere effektiviteten, sikkerheten og toleransen til Rocatinlimab (AMG 451) hos ungdommer med moderat til alvorlig atopisk dermatitt (AD) ( ROCKET-ASTRO)

Hensikten med denne studien er å evaluere effekten og sikkerheten til rocatinlimab i monoterapi og kombinasjonsbehandling hos ungdom.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

532

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Brussels, Belgia, 1070
        • Hopital Erasme
      • Brussels, Belgia, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Ghent, Belgia, 9000
        • Universitair Ziekenhuis Gent
      • Liège, Belgia, 4000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
      • Maldegem, Belgia, 9990
        • Dermatologie Maldegem
  • Brasil
      • Rio de Janeiro, Brasil, 20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
    • Espírito Santo
      • Vitória, Espírito Santo, Brasil, 29055-450
        • Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasil, 41820-020
        • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30575-180
        • Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    • São Paulo
      • Jaú, São Paulo, Brasil, 17201-130
        • Cecip Centro Est Clin Int Paulista
      • Ribeirão Preto, São Paulo, Brasil, 14026-020
        • Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
      • São José do Rio Preto, São Paulo, Brasil, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo, São Paulo, Brasil, 01228-200
        • Instituto Pesquisa e Ensino em Saúde Infantil
      • São Paulo, São Paulo, Brasil, 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 Clínicos
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35244
        • Cahaba Dermatology and Skin Health Center
      • Cullman, Alabama, Forente stater, 35058
        • AllerVie Clinical Research- Cullman
    • Arizona
      • Tucson, Arizona, Forente stater, 85745
        • Eclipse Clinical Research
    • Arkansas
      • North Little Rock, Arkansas, Forente stater, 72117
        • Arkansas Research Trials, LLC
    • California
      • Fremont, California, Forente stater, 94538
        • Center for Dermatology Clinical Research Inc
      • Fullerton, California, Forente stater, 92831
        • Doc1 Healthcare Systems Incorporated
      • Inglewood, California, Forente stater, 90301
        • Axon Clinical Research
      • Laguna Niguel, California, Forente stater, 92677
        • Avance Clinical Trials
      • Palmdale, California, Forente stater, 93551
        • Cura Clinical Research
      • Sacramento, California, Forente stater, 95815
        • Integrative Skin Science and Research
      • Sacramento, California, Forente stater, 95816
        • University of California at Davis Medical Center
      • San Diego, California, Forente stater, 92123
        • Allergy and Asthma Medical Group and Research Center
      • San Diego, California, Forente stater, 92123
        • University of California at San Diego Rady Childrens Hospital San Diego
      • Santa Monica, California, Forente stater, 90404
        • Clinical Science Institute
      • Sherman Oaks, California, Forente stater, 91403
        • Cura Clinical Research Sherman Oaks
    • Colorado
      • Denver, Colorado, Forente stater, 80209
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • Childrens National Medical Center
    • Florida
      • Brandon, Florida, Forente stater, 33511
        • Clinical Research of Brandon
      • Clearwater, Florida, Forente stater, 33761
        • Academic Alliance in Dermatology - Saint Petersburg Office
      • Coral Springs, Florida, Forente stater, 33071
        • Corazon United States of America, LLC doing business as Life Clinical Trials
      • Delray Beach, Florida, Forente stater, 33484
        • Palm Beach Dermatology Group
      • Hialeah, Florida, Forente stater, 33012
        • Direct Helpers Research Center
      • Margate, Florida, Forente stater, 33063
        • Glick Skin Institute
      • Miami, Florida, Forente stater, 33155
        • Miami Clinical Research
      • Miami, Florida, Forente stater, 33176
        • ara Professionals Limited Liability Corporation
      • Miami Lakes, Florida, Forente stater, 33014
        • Savin Medical Group LLC
      • Miami Lakes, Florida, Forente stater, 33016
        • Angels Clinical Research Institute
      • Miami Lakes, Florida, Forente stater, 33014
        • Deluxe Health Care LLC
      • Orange City, Florida, Forente stater, 32763
        • Optimal Research Sites, LLC
      • Orlando, Florida, Forente stater, 32819
        • Clinical Research Investments
      • Orlando, Florida, Forente stater, 32819
        • Clinical Associates of Orlando Limited Liability Company
      • Tampa, Florida, Forente stater, 33612
        • University of South Florida
    • Georgia
      • Columbus, Georgia, Forente stater, 31904
        • Centricity Research Columbus
      • Sandy Springs, Georgia, Forente stater, 30328
        • Advanced Medical Research Pc
      • Savannah, Georgia, Forente stater, 31419
        • Divine Dermatology and Aesthetics
      • Thomasville, Georgia, Forente stater, 31792
        • McIntosh Clinic PC
    • Idaho
      • Boise, Idaho, Forente stater, 83706-1345
        • Treasure Valley Medical Research
      • Meridian, Idaho, Forente stater, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Skokie, Illinois, Forente stater, 60077
        • NorthShore University HealthSystem Clinical Trials Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • New Albany, Indiana, Forente stater, 47150
        • Southern Indiana Clinical Trials
      • Plainfield, Indiana, Forente stater, 46168
        • The Indiana Clinical Trials Center PC
    • Kentucky
      • Bowling Green, Kentucky, Forente stater, 42104
        • Equity Medical
      • Murray, Kentucky, Forente stater, 42071
        • Kentucky Advanced Medical Research LLC
    • Louisiana
      • Monroe, Louisiana, Forente stater, 71201
        • Industrial Medicine Associates Clinical Research Advanced Dermatology Care
    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • Aesthetic and Dermatology Center
      • Rockville, Maryland, Forente stater, 20850
        • Derm Associates, PC
    • Michigan
      • Auburn Hills, Michigan, Forente stater, 48326
        • Oakland Hills Dermatology
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Health System
      • Flint, Michigan, Forente stater, 48532
        • Onyx Clinical Research
    • Missouri
      • Saint Joseph, Missouri, Forente stater, 64506
        • MediSearch Clinical Trials
      • St Louis, Missouri, Forente stater, 63110
        • Saint Louis University
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68505
        • Somnos Clinical Research
    • Nevada
      • Reno, Nevada, Forente stater, 89509
        • Skin Cancer and Dermatology Institute
    • New Hampshire
      • Portsmouth, New Hampshire, Forente stater, 03801
        • Allcutis Research
    • New Jersey
      • Bridgewater, New Jersey, Forente stater, 08807
        • The Dermatology Center of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • University of New Mexico
    • New York
      • Brooklyn, New York, Forente stater, 11211
        • Ace Clinical Trials
      • East Syracuse, New York, Forente stater, 13057
        • Empire Dermatology
      • Jackson Heights, New York, Forente stater, 11372
        • Smart Medical Research Inc
      • Kew Gardens, New York, Forente stater, 11415
        • Forest Hills Dermatology Group
      • New York, New York, Forente stater, 10016
        • Pioneer Clinical Research New York
      • New York, New York, Forente stater, 10075
        • Cornell University - Weill Cornell Medicine
      • Rochester, New York, Forente stater, 14609
        • Rochester Clinical Research
      • The Bronx, New York, Forente stater, 10467
        • Yeshiva University - Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Forente stater, 27713
        • Duke South Durham
    • Ohio
      • Boardman, Ohio, Forente stater, 44512
        • Optima Research
      • Mayfield Heights, Ohio, Forente stater, 44124
        • Apex Clinical Research Center LLC
    • Oklahoma
      • Chickasha, Oklahoma, Forente stater, 73018
        • Epic Medical Research - Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Dermatology and Aesthetics of Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Forente stater, 74137
        • Essential Medical Research LLC
    • Oregon
      • Grants Pass, Oregon, Forente stater, 97527
        • Velocity Clinical Research - Grants Pass
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19103
        • Paddington Testing Company Inc
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital, Lifespan
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina
      • North Charleston, South Carolina, Forente stater, 29420
        • National Allergy and Asthma Research, LLC
      • Summerville, South Carolina, Forente stater, 29486
        • Coastal Pediatric Research
    • Tennessee
      • Morristown, Tennessee, Forente stater, 37813
        • HealthStar Physicians Dermatology
    • Texas
      • Bellaire, Texas, Forente stater, 77401
        • The University of Texas Health Science Center at Houston
      • Cedar Park, Texas, Forente stater, 78613
        • US Dermatology Partners Cedar Park
      • Cypress, Texas, Forente stater, 77429
        • Studies in Dermatology LLC
      • Houston, Texas, Forente stater, 77037
        • MedCare Pharma - Houston
      • Houston, Texas, Forente stater, 77098
        • Tranquil Clinical Research
      • Kerrville, Texas, Forente stater, 78028
        • Sante Clinical Research
      • Lubbock, Texas, Forente stater, 79424
        • Long and Harris Dermatology
      • Mesquite, Texas, Forente stater, 75149
        • Sms Clinical Research Limited Liability Company
      • Missouri City, Texas, Forente stater, 77459
        • Sienna Dermatology Research
      • San Antonio, Texas, Forente stater, 78218
        • Texas Dermatology and Laser Specialists
      • Southlake, Texas, Forente stater, 76092
        • Epiphany Dermatology
      • Sugar Land, Texas, Forente stater, 77479
        • Pioneer Research Solutions
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Tanner Clinic
      • Providence, Utah, Forente stater, 84332
        • Dermatology Research of Utah, dba Providence Dermatology
      • South Jordan, Utah, Forente stater, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Franklin, Virginia, Forente stater, 23851
        • Maria M Ona MD PC
    • Washington
      • Bellevue, Washington, Forente stater, 98007
        • Northwest Clinical Research Center
  • Frankrike
      • Antony, Frankrike, 92160
        • Hopital Prive d Antony
      • Brest, Frankrike, 29200
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
      • Marseille, Frankrike, 13285
        • Hôpital Saint-Joseph
      • Nantes, Frankrike, 44093
        • Centre Hospitalier Universitaire de Nantes Hôtel Dieu
      • Rennes, Frankrike, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
      • Rouen, Frankrike, 76031
        • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
      • Toulouse, Frankrike, 31059
        • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
  • Hellas
      • Athens, Hellas, 11521
        • Athens Naval Hospital
      • Athens, Hellas, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Athens, Hellas, 11527
        • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
      • Thessaloniki, Hellas, 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
  • Italia
      • Milan, Italia, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Naples, Italia, 80131
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
      • Perugia, Italia, 06129
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Torino, Italia, 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
  • Kroatia
      • Ivanić-Grad, Kroatia, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Osijek, Kroatia, 31000
        • University Hospital Centre Osijek
      • Zagreb, Kroatia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Kroatia, 10000
        • Sestre milosrdnice University Hospital Center
      • Zagreb, Kroatia, 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
  • Romania
      • Bucharest, Romania, 011216
        • Dr Leventer Centre Clinica Dermatologie Bucuresti
      • Cluj-Napoca, Romania, 400431
        • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
      • Cluj-Napoca, Romania, 400105
        • Derma Cluj
  • Spania
      • Madrid, Spania, 28046
        • Hospital Universitario La Paz
      • Madrid, Spania, 28007
        • Hospital General Universitario Gregorio Marañón
    • Catalonia
      • Barcelona, Catalonia, Spania, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Esplugues de Llobregat, Catalonia, Spania, 08950
        • Hospital Sant Joan de Déu
    • Navarre
      • Pamplona, Navarre, Spania, 31008
        • Clinica Universidad de Navarra
  • Sør -Korea
      • Ansansi, Gyeonggido, Sør -Korea, 15355
        • Korea University Ansan Hospital
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Sør -Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Sør -Korea, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Sør -Korea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Sør -Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Sør -Korea, 08308
        • Korea University Guro Hospital
      • Seoul, Sør -Korea, 06973
        • Chung-Ang University Hospital
      • Seoul, Sør -Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Sør -Korea, 04564
        • National Medical Center
      • Seoul, Sør -Korea, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Alder ≥ 12 til < 18 år på dag 1.
  • Kroppsvekt ≥ 40 kg ved screening.
  • Anamnese med utilstrekkelig respons på TCS med middels eller høyere styrke innen 6 måneder (med eller uten TCI).
  • EASI-score ≥ 16.
  • vIGA-AD-score ≥ 3.
  • ≥10 % kroppsoverflateareal (BSA) av AD-involvering.
  • Verste kløe NRS ≥ 4.

Ekskluderingskriterier:

  • Behandling med et biologisk produkt innen 12 uker eller 5 halveringstider, avhengig av hva som er lengst, før dag 1.

  • Behandling med noen av følgende medisiner eller terapier innen 4 uker eller 5 halveringstider, avhengig av hva som er lengst, før dag 1:

    1. Systemiske kortikosteroider
    2. Systemiske immundempende midler
    3. Fototerapi
    4. Orale eller aktuelle Janus kinasehemmere

  • Behandling med noen av følgende medisiner eller terapier innen 1 uke, før dag 1:

    1. TCS
    2. TCI
    3. Aktuelle fosfodiesterase type 4-hemmere
    4. Andre aktuelle immunsuppressive midler

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A: Dose 1

Del 1 (Startperiode); Uke 0 til uke 24: Rocatinlimab Dose 1 hver 4. uke (Q4W) i 24 uker med startdose ved uke 2 (+ topikale kortikosteroider (TCS)/ topikal kalsineurinhemmer (TCI) hvis innenfor kombinasjonsterapikohort).

Del 2 (Vedlikeholdsperiode); Uke 24 til uke 52: Del 1-respondenter vil bli rerandomisert ved uke 24 til Rocatinlimab-dose 1 Q4W eller hver 8. uke (Q8W) i 28 uker (+ TCS/TCI hvis innenfor kombinasjonsterapi-kohorten).
Legemiddel: Rocatinlimab
Subkutan (SC) injeksjon
Andre navn:
  • AMG 451
Eksperimentell: Arm B: Dose 2

Del 1 (Startperiode); Uke 0 til uke 24: Rocatinlimab Dose 2 Q4W i 24 uker med startdose ved uke 2 (+TCS/TCI hvis innenfor kombinasjonsterapikohort).

Del 2 (Vedlikeholdsperiode); Uke 24 til uke 52: Del 1-respondenter vil bli rerandomisert ved uke 24 til Rocatinlimab Dose 2 Q4W eller Q8W i 28 uker (med TCS/TCI hvis innenfor kombinasjonsterapi-kohorten).
Legemiddel: Rocatinlimab
Subkutan (SC) injeksjon
Andre navn:
  • AMG 451
Eksperimentell: Arm C: Placebo

Del 1 (Startperiode); Uke 0 til uke 24: Placebo Q4W i 24 uker med startdose ved uke 2 (+TCS/TCI hvis innenfor kombinasjonsterapikohort).

Del 2 (Vedlikeholdsperiode); Uke 24 til uke 52: Del 1-respondenter vil bli tildelt på nytt ved uke 24 med placebo Q4W i 28 uker (med TCS/TCI hvis innenfor kombinasjonsterapi-kohorten).
Legemiddel: Placebo
SC-injeksjon
Eksperimentell: Arm D: Åpen etikett dose 1
Del 2; Uke 24 til uke 52: Ikke-respondere i del 1 vil bli tildelt på nytt ved uke 24 med Rocatinlimab åpen dose 1 Q4W i 28 uker (med TCS/TCI hvis innenfor kombinasjonsterapikohorten). Deltakere i arm A, B eller C vedlikeholdsperiode vil bli tildelt Rocatinlimab åpen dose 1 Q4W (med TCS/TCI hvis innenfor kombinasjonsterapikohort) ved tilbakefall etter uke 24.
Legemiddel: Rocatinlimab
Subkutan (SC) injeksjon
Andre navn:
  • AMG 451

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amgen

Etterforskere

  • Studieleder: MD, Amgen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. april 2023

Primær fullføring (Faktiske)

27. februar 2025

Studiet fullført (Faktiske)

25. november 2025

Datoer for studieregistrering

Først innsendt

20. januar 2023

Først innsendt som oppfylte QC-kriteriene

20. januar 2023

Først lagt ut (Faktiske)

30. januar 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Avidentifiserte individuelle pasientdata for variabler som er nødvendige for å adressere det spesifikke forskningsspørsmålet i en godkjent forespørsel om datadeling.

IPD-delingstidsramme

Forespørsler om datadeling knyttet til denne studien vil bli vurdert med start 18 måneder etter at studien er avsluttet og enten 1) produktet og indikasjonen har fått markedsføringstillatelse i både USA og Europa eller 2) klinisk utvikling for produktet og/eller indikasjonen avbrytes og dataene vil ikke bli sendt til regulerende myndigheter. Det er ingen sluttdato for kvalifisering til å sende inn en forespørsel om datadeling for denne studien.

Tilgangskriterier for IPD-deling

Kvalifiserte forskere kan sende inn en forespørsel som inneholder forskningsmålene, Amgen-produktet(e) og Amgen-studien/studiene i omfang, endepunkter/resultater av interesse, statistisk analyseplan, datakrav, publiseringsplan og kvalifikasjonene til forskeren(e). Generelt innvilger ikke Amgen eksterne forespørsler om individuelle pasientdata med det formål å revurdere sikkerhets- og effektspørsmål som allerede er behandlet i produktmerkingen. Forespørsler vurderes av et utvalg av interne rådgivere. Hvis den ikke blir godkjent, vil et uavhengig granskningspanel for datadeling dømme og ta den endelige avgjørelsen. Ved godkjenning vil informasjon som er nødvendig for å løse forskningsspørsmålet, bli gitt under vilkårene i en datadelingsavtale. Dette kan inkludere anonymiserte individuelle pasientdata og/eller tilgjengelige støttedokumenter, som inneholder fragmenter av analysekode der det er gitt i analysespesifikasjonene. Ytterligere detaljer er tilgjengelig på URL-en nedenfor.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere