Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Uno studio per valutare il rocatinlimab (AMG 451) in soggetti adolescenti con dermatite atopica da moderata a grave (AD) (ROCKET-ASTRO)

6 agosto 2026 aggiornato da: Amgen

Uno studio di fase 3, randomizzato, di 52 settimane, controllato con placebo, in doppio cieco con ri-randomizzazione per valutare l'efficacia, la sicurezza e la tollerabilità di Rocatinlimab (AMG 451) in soggetti adolescenti con dermatite atopica da moderata a grave (AD) ( ROCKET-ASTRO)

Lo scopo di questo studio è valutare l'efficacia e la sicurezza di rocatinlimab in monoterapia e terapia di combinazione in soggetti adolescenti.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

532

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 17 anni (Bambino)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Età da ≥ 12 a < 18 anni al giorno 1.
  • Peso corporeo ≥ 40 kg allo screening.
  • Storia di risposta inadeguata a TCS di potenza media o superiore entro 6 mesi (con o senza TCI).
  • Punteggio EASI ≥ 16.
  • Punteggio vIGA-AD ≥ 3.
  • ≥10% della superficie corporea (BSA) di coinvolgimento AD.
  • Prurito peggiore NRS ≥ 4.

Criteri di esclusione:

  • Trattamento con un prodotto biologico entro 12 settimane o 5 emivite, a seconda di quale sia il periodo più lungo, prima del giorno 1.

  • Trattamento con uno qualsiasi dei seguenti farmaci o terapie entro 4 settimane o 5 emivite, qualunque sia il più lungo, prima del Giorno 1:

    1. Corticosteroidi sistemici
    2. Immunosoppressori sistemici
    3. Fototerapia
    4. Inibitori della Janus chinasi per uso orale o topico

  • Trattamento con uno qualsiasi dei seguenti farmaci o terapie entro 1 settimana, prima del Giorno 1:

    1. TCS
    2. TCI
    3. Inibitori topici della fosfodiesterasi di tipo 4
    4. Altri agenti immunosoppressori topici

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Braccio A: Dose 1

Parte 1 (Periodo iniziale); Dalla settimana 0 alla settimana 24: Rocatinlimab Dose 1 ogni 4 settimane (Q4W) per 24 settimane con dose di carico alla settimana 2 (+ corticosteroidi topici (TCS)/inibitore topico della calcineurina (TCI) se all'interno della coorte della terapia di combinazione).

Parte 2 (Periodo di manutenzione); Dalla settimana 24 alla settimana 52: Parte 1 I responder saranno randomizzati nuovamente alla settimana 24 alla dose 1 di rocatinlimab Q4W o ogni 8 settimane (Q8W) per 28 settimane (+ TCS/TCI se all'interno della coorte della terapia di combinazione).
Droga: Rocatinlimab
Iniezione sottocutanea (SC).
Altri nomi:
  • AM 451
Sperimentale: Braccio B: Dose 2

Parte 1 (Periodo iniziale); Dalla settimana 0 alla settimana 24: Rocatinlimab Dose 2 Q4W per 24 settimane con dose di carico alla Settimana 2 (+TCS/TCI se all'interno della coorte di terapia di combinazione).

Parte 2 (Periodo di manutenzione); Dalla settimana 24 alla settimana 52: i responder della Parte 1 saranno nuovamente randomizzati alla settimana 24 alla dose 2 di rocatinlimab ogni 4 settimane o ogni 8 settimane per 28 settimane (con TCS/TCI se all'interno della coorte della terapia di combinazione).
Droga: Rocatinlimab
Iniezione sottocutanea (SC).
Altri nomi:
  • AM 451
Sperimentale: Braccio C: Placebo

Parte 1 (Periodo iniziale); Dalla settimana 0 alla settimana 24: Placebo Q4W per 24 settimane con dose di carico alla settimana 2 (+TCS/TCI se all'interno della coorte di terapia di combinazione).

Parte 2 (Periodo di manutenzione); Dalla settimana 24 alla settimana 52: i responder della parte 1 verranno riassegnati alla settimana 24 con placebo Q4W per 28 settimane (con TCS/TCI se all'interno della coorte di terapia di combinazione).
Droga: Placebo
Iniezione SC
Sperimentale: Braccio D: Dose in aperto 1
Parte 2; Dalla settimana 24 alla settimana 52: i non-responder della parte 1 verranno riassegnati alla settimana 24 con Rocatinlimab in aperto Dose 1 Q4W per 28 settimane (con TCS/TCI se all'interno della coorte della terapia di combinazione). I partecipanti al periodo di mantenimento dei bracci A, B o C verranno riassegnati con Rocatinlimab Dose 1 in aperto Q4W (con TCS/TCI se all'interno della coorte di terapia di combinazione) in caso di ricaduta dopo la settimana 24.
Droga: Rocatinlimab
Iniezione sottocutanea (SC).
Altri nomi:
  • AM 451

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Who Achieved EASI 75 at Week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Investigatori

  • Direttore dello studio: MD, Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 aprile 2023

Completamento primario (Effettivo)

27 febbraio 2025

Completamento dello studio (Effettivo)

25 novembre 2025

Date di iscrizione allo studio

Primo inviato

20 gennaio 2023

Primo inviato che soddisfa i criteri di controllo qualità

20 gennaio 2023

Primo Inserito (Effettivo)

30 gennaio 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20210145
  • 2022-501586-50 (Altro identificatore: EUCTR)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Dati dei singoli pazienti anonimizzati per le variabili necessarie per affrontare la domanda di ricerca specifica in una richiesta di condivisione dei dati approvata.

Periodo di condivisione IPD

Le richieste di condivisione dei dati relative a questo studio saranno prese in considerazione a partire da 18 mesi dopo la conclusione dello studio e se 1) il prodotto e l'indicazione hanno ottenuto l'autorizzazione all'immissione in commercio sia negli Stati Uniti che in Europa o 2) lo sviluppo clinico per il prodotto e/o l'indicazione viene interrotto e i dati non saranno presentati alle autorità di regolamentazione. Non esiste una data di fine per l'idoneità a inviare una richiesta di condivisione dei dati per questo studio.

Criteri di accesso alla condivisione IPD

I ricercatori qualificati possono presentare una richiesta contenente gli obiettivi della ricerca, il/i prodotto/i Amgen e lo/gli studio/studi Amgen nell'ambito, gli endpoint/i risultati di interesse, il piano di analisi statistica, i requisiti in materia di dati, il piano di pubblicazione e le qualifiche del/i ricercatore/i. In generale, Amgen non soddisfa le richieste esterne di dati dei singoli pazienti allo scopo di rivalutare i problemi di sicurezza ed efficacia già affrontati nell'etichettatura del prodotto. Le richieste vengono esaminate da un comitato di consulenti interni. In caso di mancata approvazione, un comitato di revisione indipendente sulla condivisione dei dati arbitrerà e prenderà la decisione finale. Dopo l'approvazione, le informazioni necessarie per affrontare la domanda di ricerca saranno fornite secondo i termini di un accordo di condivisione dei dati. Ciò può includere dati anonimizzati di singoli pazienti e/o documenti di supporto disponibili, contenenti frammenti di codice di analisi ove previsto nelle specifiche di analisi. Ulteriori dettagli sono disponibili all'URL sottostante.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi