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Een onderzoek ter evaluatie van Rocatinlimab (AMG 451) bij adolescenten met matige tot ernstige atopische dermatitis (AD) (ROCKET-ASTRO)

6 augustus 2026 bijgewerkt door: Amgen

Een gerandomiseerde, 52 weken durende, placebogecontroleerde, dubbelblinde fase 3-studie met herrandomisatie om de werkzaamheid, veiligheid en verdraagbaarheid van Rocatinlimab (AMG 451) te beoordelen bij adolescenten met matige tot ernstige atopische dermatitis (AD) ( RAKET-ASTRO)

Het doel van deze studie is het evalueren van de werkzaamheid en veiligheid van rocatinlimab bij monotherapie en combinatietherapie bij adolescente proefpersonen.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

532

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Brussels, België, 1070
        • Hopital Erasme
      • Brussels, België, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Ghent, België, 9000
        • Universitair Ziekenhuis Gent
      • Liège, België, 4000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
      • Maldegem, België, 9990
        • Dermatologie Maldegem
  • Brazilië
      • Rio de Janeiro, Brazilië, 20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
    • Espírito Santo
      • Vitória, Espírito Santo, Brazilië, 29055-450
        • Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazilië, 41820-020
        • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazilië, 30575-180
        • Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    • São Paulo
      • Jaú, São Paulo, Brazilië, 17201-130
        • Cecip Centro Est Clin Int Paulista
      • Ribeirão Preto, São Paulo, Brazilië, 14026-020
        • Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
      • São José do Rio Preto, São Paulo, Brazilië, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo, São Paulo, Brazilië, 01228-200
        • Instituto Pesquisa e Ensino em Saúde Infantil
      • São Paulo, São Paulo, Brazilië, 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
  • Chili
      • Osorno, Chili, 5310644
        • Centro Dermatologico Dermisur
      • Santiago, Chili, 7640881
        • Clinica Dermacross SA
      • Santiago, Chili, 7580206
        • Centro Medico Skinmed Spa
      • Santiago, Chili, 8380465
        • Fundacion Innovacion Cardiovascular
      • Santiago, Chili, 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
  • Duitsland
      • Bad Bentheim, Duitsland, 48455
        • Fachklinik Bad Bentheim
      • Bonn, Duitsland, 53127
        • Universitaetsklinikum Bonn
      • Darmstadt, Duitsland, 64283
        • Rosenpark Research GmbH
      • Dresden, Duitsland, 01307
        • Universitaetsklinikum Dresden
      • Erlangen, Duitsland, 91054
        • Universitaetsklinikum Erlangen
      • Frankfurt am Main, Duitsland, 60590
        • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
      • Leipzig, Duitsland, 04103
        • Velocity Clinical Research
      • Mainz, Duitsland, 55101
        • Johannes Gutenberg Universitaet Mainz
  • Frankrijk
      • Antony, Frankrijk, 92160
        • Hopital Prive d Antony
      • Brest, Frankrijk, 29200
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
      • Marseille, Frankrijk, 13285
        • Hôpital Saint-Joseph
      • Nantes, Frankrijk, 44093
        • Centre Hospitalier Universitaire de Nantes Hôtel Dieu
      • Rennes, Frankrijk, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
      • Rouen, Frankrijk, 76031
        • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
      • Toulouse, Frankrijk, 31059
        • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
  • Griekenland
      • Athens, Griekenland, 11521
        • Athens Naval Hospital
      • Athens, Griekenland, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Athens, Griekenland, 11527
        • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
      • Thessaloniki, Griekenland, 54643
        • Ippokratio General Hospital of Thessaloniki
  • Hongarije
      • Budapest, Hongarije, 1033
        • Clinexpert Kft
      • Debrecen, Hongarije, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hongarije, 4031
        • Derma-B Egeszsegugyi es Szolgaltato Kft
      • Kaposvár, Hongarije, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Israël
      • Bear Sheva, Israël, 8410101
        • Soroka Medical Center
      • Ramat Gan, Israël, 5262000
        • Sheba medical center
      • Tel Aviv, Israël, 6423906
        • Sourasky Medical Center
  • Italië
      • Milan, Italië, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Naples, Italië, 80131
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
      • Perugia, Italië, 06129
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Torino, Italië, 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
  • Kroatië
      • Ivanić-Grad, Kroatië, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Osijek, Kroatië, 31000
        • University Hospital Centre Osijek
      • Zagreb, Kroatië, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Kroatië, 10000
        • Sestre milosrdnice University Hospital Center
      • Zagreb, Kroatië, 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
  • Roemenië
      • Bucharest, Roemenië, 011216
        • Dr Leventer Centre Clinica Dermatologie Bucuresti
      • Cluj-Napoca, Roemenië, 400431
        • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
      • Cluj-Napoca, Roemenië, 400105
        • Derma Cluj
  • Spanje
      • Madrid, Spanje, 28046
        • Hospital Universitario La Paz
      • Madrid, Spanje, 28007
        • Hospital General Universitario Gregorio Marañón
    • Catalonia
      • Barcelona, Catalonia, Spanje, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Esplugues de Llobregat, Catalonia, Spanje, 08950
        • Hospital Sant Joan de Déu
    • Navarre
      • Pamplona, Navarre, Spanje, 31008
        • Clinica Universidad de Navarra
  • 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
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35244
        • Cahaba Dermatology and Skin Health Center
      • Cullman, Alabama, Verenigde Staten, 35058
        • AllerVie Clinical Research- Cullman
    • Arizona
      • Tucson, Arizona, Verenigde Staten, 85745
        • Eclipse Clinical Research
    • Arkansas
      • North Little Rock, Arkansas, Verenigde Staten, 72117
        • Arkansas Research Trials, LLC
    • California
      • Fremont, California, Verenigde Staten, 94538
        • Center for Dermatology Clinical Research Inc
      • Fullerton, California, Verenigde Staten, 92831
        • Doc1 Healthcare Systems Incorporated
      • Inglewood, California, Verenigde Staten, 90301
        • Axon Clinical Research
      • Laguna Niguel, California, Verenigde Staten, 92677
        • Avance Clinical Trials
      • Palmdale, California, Verenigde Staten, 93551
        • Cura Clinical Research
      • Sacramento, California, Verenigde Staten, 95815
        • Integrative Skin Science and Research
      • Sacramento, California, Verenigde Staten, 95816
        • University of California at Davis Medical Center
      • San Diego, California, Verenigde Staten, 92123
        • Allergy and Asthma Medical Group and Research Center
      • San Diego, California, Verenigde Staten, 92123
        • University of California at San Diego Rady Childrens Hospital San Diego
      • Santa Monica, California, Verenigde Staten, 90404
        • Clinical Science Institute
      • Sherman Oaks, California, Verenigde Staten, 91403
        • Cura Clinical Research Sherman Oaks
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80209
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, Verenigde Staten, 20010
        • Childrens National Medical Center
    • Florida
      • Brandon, Florida, Verenigde Staten, 33511
        • Clinical Research of Brandon
      • Clearwater, Florida, Verenigde Staten, 33761
        • Academic Alliance in Dermatology - Saint Petersburg Office
      • Coral Springs, Florida, Verenigde Staten, 33071
        • Corazon United States of America, LLC doing business as Life Clinical Trials
      • Delray Beach, Florida, Verenigde Staten, 33484
        • Palm Beach Dermatology Group
      • Hialeah, Florida, Verenigde Staten, 33012
        • Direct Helpers Research Center
      • Margate, Florida, Verenigde Staten, 33063
        • Glick Skin Institute
      • Miami, Florida, Verenigde Staten, 33155
        • Miami Clinical Research
      • Miami, Florida, Verenigde Staten, 33176
        • ara Professionals Limited Liability Corporation
      • Miami Lakes, Florida, Verenigde Staten, 33014
        • Savin Medical Group LLC
      • Miami Lakes, Florida, Verenigde Staten, 33016
        • Angels Clinical Research Institute
      • Miami Lakes, Florida, Verenigde Staten, 33014
        • Deluxe Health Care LLC
      • Orange City, Florida, Verenigde Staten, 32763
        • Optimal Research Sites, LLC
      • Orlando, Florida, Verenigde Staten, 32819
        • Clinical Research Investments
      • Orlando, Florida, Verenigde Staten, 32819
        • Clinical Associates of Orlando Limited Liability Company
      • Tampa, Florida, Verenigde Staten, 33612
        • University of South Florida
    • Georgia
      • Columbus, Georgia, Verenigde Staten, 31904
        • Centricity Research Columbus
      • Sandy Springs, Georgia, Verenigde Staten, 30328
        • Advanced Medical Research Pc
      • Savannah, Georgia, Verenigde Staten, 31419
        • Divine Dermatology and Aesthetics
      • Thomasville, Georgia, Verenigde Staten, 31792
        • McIntosh Clinic PC
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83706-1345
        • Treasure Valley Medical Research
      • Meridian, Idaho, Verenigde Staten, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Skokie, Illinois, Verenigde Staten, 60077
        • NorthShore University HealthSystem Clinical Trials Center
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • New Albany, Indiana, Verenigde Staten, 47150
        • Southern Indiana Clinical Trials
      • Plainfield, Indiana, Verenigde Staten, 46168
        • The Indiana Clinical Trials Center PC
    • Kentucky
      • Bowling Green, Kentucky, Verenigde Staten, 42104
        • Equity Medical
      • Murray, Kentucky, Verenigde Staten, 42071
        • Kentucky Advanced Medical Research LLC
    • Louisiana
      • Monroe, Louisiana, Verenigde Staten, 71201
        • Industrial Medicine Associates Clinical Research Advanced Dermatology Care
    • Maryland
      • Rockville, Maryland, Verenigde Staten, 20850
        • Aesthetic and Dermatology Center
      • Rockville, Maryland, Verenigde Staten, 20850
        • Derm Associates, PC
    • Michigan
      • Auburn Hills, Michigan, Verenigde Staten, 48326
        • Oakland Hills Dermatology
      • Detroit, Michigan, Verenigde Staten, 48202
        • Henry Ford Health System
      • Flint, Michigan, Verenigde Staten, 48532
        • Onyx Clinical Research
    • Missouri
      • Saint Joseph, Missouri, Verenigde Staten, 64506
        • MediSearch Clinical Trials
      • St Louis, Missouri, Verenigde Staten, 63110
        • Saint Louis University
    • Nebraska
      • Lincoln, Nebraska, Verenigde Staten, 68505
        • Somnos Clinical Research
    • Nevada
      • Reno, Nevada, Verenigde Staten, 89509
        • Skin Cancer and Dermatology Institute
    • New Hampshire
      • Portsmouth, New Hampshire, Verenigde Staten, 03801
        • Allcutis Research
    • New Jersey
      • Bridgewater, New Jersey, Verenigde Staten, 08807
        • The Dermatology Center of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87102
        • University of New Mexico
    • New York
      • Brooklyn, New York, Verenigde Staten, 11211
        • Ace Clinical Trials
      • East Syracuse, New York, Verenigde Staten, 13057
        • Empire Dermatology
      • Jackson Heights, New York, Verenigde Staten, 11372
        • Smart Medical Research Inc
      • Kew Gardens, New York, Verenigde Staten, 11415
        • Forest Hills Dermatology Group
      • New York, New York, Verenigde Staten, 10016
        • Pioneer Clinical Research New York
      • New York, New York, Verenigde Staten, 10075
        • Cornell University - Weill Cornell Medicine
      • Rochester, New York, Verenigde Staten, 14609
        • Rochester Clinical Research
      • The Bronx, New York, Verenigde Staten, 10467
        • Yeshiva University - Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27713
        • Duke South Durham
    • Ohio
      • Boardman, Ohio, Verenigde Staten, 44512
        • Optima Research
      • Mayfield Heights, Ohio, Verenigde Staten, 44124
        • Apex Clinical Research Center LLC
    • Oklahoma
      • Chickasha, Oklahoma, Verenigde Staten, 73018
        • Epic Medical Research - Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, Verenigde Staten, 73120
        • Dermatology and Aesthetics of Oklahoma
      • Tulsa, Oklahoma, Verenigde Staten, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Verenigde Staten, 74137
        • Essential Medical Research LLC
    • Oregon
      • Grants Pass, Oregon, Verenigde Staten, 97527
        • Velocity Clinical Research - Grants Pass
      • Portland, Oregon, Verenigde Staten, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19103
        • Paddington Testing Company Inc
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02903
        • Rhode Island Hospital, Lifespan
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Medical University of South Carolina
      • North Charleston, South Carolina, Verenigde Staten, 29420
        • National Allergy and Asthma Research, LLC
      • Summerville, South Carolina, Verenigde Staten, 29486
        • Coastal Pediatric Research
    • Tennessee
      • Morristown, Tennessee, Verenigde Staten, 37813
        • HealthStar Physicians Dermatology
    • Texas
      • Bellaire, Texas, Verenigde Staten, 77401
        • The University of Texas Health Science Center at Houston
      • Cedar Park, Texas, Verenigde Staten, 78613
        • US Dermatology Partners Cedar Park
      • Cypress, Texas, Verenigde Staten, 77429
        • Studies in Dermatology LLC
      • Houston, Texas, Verenigde Staten, 77037
        • MedCare Pharma - Houston
      • Houston, Texas, Verenigde Staten, 77098
        • Tranquil Clinical Research
      • Kerrville, Texas, Verenigde Staten, 78028
        • Sante Clinical Research
      • Lubbock, Texas, Verenigde Staten, 79424
        • Long and Harris Dermatology
      • Mesquite, Texas, Verenigde Staten, 75149
        • Sms Clinical Research Limited Liability Company
      • Missouri City, Texas, Verenigde Staten, 77459
        • Sienna Dermatology Research
      • San Antonio, Texas, Verenigde Staten, 78218
        • Texas Dermatology and Laser Specialists
      • Southlake, Texas, Verenigde Staten, 76092
        • Epiphany Dermatology
      • Sugar Land, Texas, Verenigde Staten, 77479
        • Pioneer Research Solutions
    • Utah
      • Murray, Utah, Verenigde Staten, 84107
        • Tanner Clinic
      • Providence, Utah, Verenigde Staten, 84332
        • Dermatology Research of Utah, dba Providence Dermatology
      • South Jordan, Utah, Verenigde Staten, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Franklin, Virginia, Verenigde Staten, 23851
        • Maria M Ona MD PC
    • Washington
      • Bellevue, Washington, Verenigde Staten, 98007
        • Northwest Clinical Research Center
  • Zuid -Korea
      • Ansansi, Gyeonggido, Zuid -Korea, 15355
        • Korea University Ansan Hospital
      • Seoul, Zuid -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Zuid -Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Zuid -Korea, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Zuid -Korea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Zuid -Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Zuid -Korea, 08308
        • Korea University Guro Hospital
      • Seoul, Zuid -Korea, 06973
        • Chung-Ang University Hospital
      • Seoul, Zuid -Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Zuid -Korea, 04564
        • National Medical Center
      • Seoul, Zuid -Korea, 07804
        • Ewha Womans University Seoul Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Leeftijd ≥ 12 tot < 18 jaar op dag 1.
  • Lichaamsgewicht ≥ 40 kg bij screening.
  • Geschiedenis van onvoldoende respons op TCS van gemiddelde of hogere potentie binnen 6 maanden (met of zonder TCI).
  • EASI-score ≥ 16.
  • vIGA-AD-score ≥ 3.
  • ≥10% lichaamsoppervlak (BSA) van AD-betrokkenheid.
  • Slechtste pruritus NRS ≥ 4.

Uitsluitingscriteria:

  • Behandeling met een biologisch product binnen 12 weken of 5 halfwaardetijden, afhankelijk van welke langer is, voorafgaand aan Dag 1.

  • Behandeling met een van de volgende medicijnen of therapieën binnen 4 weken of 5 halfwaardetijden, afhankelijk van welke langer is, voorafgaand aan Dag 1:

    1. Systemische corticosteroïden
    2. Systemische immunosuppressiva
    3. Fototherapie
    4. Orale of actuele Janus-kinaseremmers

  • Behandeling met een van de volgende medicijnen of therapieën binnen 1 week, voorafgaand aan dag 1:

    1. TCS
    2. TCI
    3. Topische fosfodiësterase type 4-remmers
    4. Andere lokale immunosuppressiva

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm A: dosis 1

Deel 1 (Aanvangsperiode); Week 0 tot week 24: Rocatinlimab dosis 1 elke 4 weken (Q4W) gedurende 24 weken met oplaaddosis in week 2 (+ topische corticosteroïden (TCS)/topische calcineurineremmer (TCI) indien binnen combinatietherapiecohort).

Deel 2 (Onderhoudsperiode); Week 24 tot week 52: deel 1 Responders worden in week 24 opnieuw gerandomiseerd naar dosis Rocatinlimab 1 Q4W of elke 8 weken (Q8W) gedurende 28 weken (+ TCS/TCI indien binnen combinatietherapiecohort).
Geneesmiddel: Rocatinlimab
Subcutane (SC) injectie
Andere namen:
  • AMG 451
Experimenteel: Arm B: dosis 2

Deel 1 (Aanvangsperiode); Week 0 tot week 24: Rocatinlimab dosis 2 Q4W gedurende 24 weken met oplaaddosis in week 2 (+TCS/TCI indien binnen combinatietherapiecohort).

Deel 2 (Onderhoudsperiode); Week 24 tot week 52: deel 1 Responders worden in week 24 opnieuw gerandomiseerd naar Rocatinlimab dosis 2 Q4W of Q8W gedurende 28 weken (met TCS/TCI indien binnen combinatietherapiecohort).
Geneesmiddel: Rocatinlimab
Subcutane (SC) injectie
Andere namen:
  • AMG 451
Experimenteel: Arm C: Placebo

Deel 1 (Aanvangsperiode); Week 0 tot week 24: Placebo Q4W gedurende 24 weken met oplaaddosis in week 2 (+TCS/TCI indien binnen combinatietherapiecohort).

Deel 2 (Onderhoudsperiode); Week 24 tot week 52: Deel 1 Responders worden in week 24 opnieuw toegewezen aan Placebo Q4W gedurende 28 weken (met TCS/TCI indien binnen combinatietherapiecohort).
Geneesmiddel: Placebo
SC-injectie
Experimenteel: Arm D: Open-label dosis 1
Deel 2; Week 24 tot week 52: Deel 1 Non-Responders zullen in week 24 opnieuw worden toegewezen aan Rocatinlimab Open-label dosis 1 Q4W gedurende 28 weken (met TCS/TCI indien binnen combinatietherapiecohort). Deelnemers in onderhoudsarm A, B of C zullen opnieuw worden toegewezen aan Rocatinlimab Open-label dosis 1 Q4W (met TCS/TCI indien binnen combinatietherapiecohort) bij terugval na week 24.
Geneesmiddel: Rocatinlimab
Subcutane (SC) injectie
Andere namen:
  • AMG 451

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Who Achieved EASI 75 at Week 16
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amgen

Onderzoekers

  • Studie directeur: MD, Amgen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 april 2023

Primaire voltooiing (Werkelijk)

27 februari 2025

Studie voltooiing (Werkelijk)

25 november 2025

Studieregistratiedata

Eerst ingediend

20 januari 2023

Eerst ingediend dat voldeed aan de QC-criteria

20 januari 2023

Eerst geplaatst (Werkelijk)

30 januari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

6 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Geanonimiseerde individuele patiëntgegevens voor variabelen die nodig zijn om de specifieke onderzoeksvraag te beantwoorden in een goedgekeurd verzoek om gegevensuitwisseling.

IPD-tijdsbestek voor delen

Verzoeken tot het delen van gegevens met betrekking tot deze studie worden overwogen vanaf 18 maanden nadat de studie is beëindigd en ofwel 1) voor het product en de indicatie een vergunning voor het in de handel brengen is verleend in zowel de VS als Europa, of 2) de klinische ontwikkeling van het product en/of de indicatie wordt stopgezet en de gegevens zullen niet worden ingediend bij regelgevende instanties. Er is geen einddatum voor het in aanmerking komen voor het indienen van een verzoek om gegevensuitwisseling voor dit onderzoek.

IPD-toegangscriteria voor delen

Gekwalificeerde onderzoekers kunnen een verzoek indienen met daarin de onderzoeksdoelstellingen, het/de Amgen-product(en) en de Amgen-studie(s) in de reikwijdte, eindpunten/uitkomsten van belang, plan voor statistische analyse, gegevensvereisten, publicatieplan en kwalificaties van de onderzoeker(s). Over het algemeen willigt Amgen geen externe verzoeken in voor individuele patiëntgegevens met als doel veiligheids- en werkzaamheidskwesties die al in de productetikettering aan bod zijn gekomen, opnieuw te evalueren. Verzoeken worden beoordeeld door een commissie van interne adviseurs. Indien niet goedgekeurd, zal een onafhankelijk beoordelingspanel voor gegevensuitwisseling arbitreren en de uiteindelijke beslissing nemen. Na goedkeuring wordt de informatie die nodig is om de onderzoeksvraag te beantwoorden verstrekt onder de voorwaarden van een overeenkomst voor het delen van gegevens. Dit kunnen geanonimiseerde individuele patiëntgegevens en/of beschikbare ondersteunende documenten zijn, die fragmenten van de analysecode bevatten, indien voorzien in de analysespecificaties. Verdere details zijn beschikbaar op de onderstaande URL.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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