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Badanie oceniające rokatynlimab (AMG 451) u młodzieży z atopowym zapaleniem skóry (AZS) o nasileniu umiarkowanym do ciężkiego (ROCKET-ASTRO)

6 sierpnia 2026 zaktualizowane przez: Amgen

Randomizowane, 52-tygodniowe, kontrolowane placebo badanie fazy 3 z podwójnie ślepą próbą i ponowną randomizacją w celu oceny skuteczności, bezpieczeństwa i tolerancji rokatynlimabu (AMG 451) u młodzieży z umiarkowanym do ciężkiego atopowym zapaleniem skóry (AZS) ( ROCKET-ASTRO)

Celem pracy jest ocena skuteczności i bezpieczeństwa rokatynlimabu w monoterapii i terapii skojarzonej u młodzieży.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

532

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Wiek od ≥ 12 do < 18 lat w dniu 1.
  • Masa ciała ≥ 40 kg podczas badania przesiewowego.
  • Historia niewystarczającej odpowiedzi na TCS o średniej lub większej mocy w ciągu 6 miesięcy (z lub bez TCI).
  • Wynik EASI ≥ 16.
  • Wynik VIGA-AD ≥ 3.
  • ≥10% powierzchni ciała (BSA) zajęcia AD.
  • Najgorszy świąd NRS ≥ 4.

Kryteria wyłączenia:

  • Leczenie produktem biologicznym w ciągu 12 tygodni lub 5 okresów półtrwania, w zależności od tego, który okres jest dłuższy, przed 1. dniem.

  • Leczenie dowolnym z poniższych leków lub terapii w ciągu 4 tygodni lub 5 okresów półtrwania, w zależności od tego, który z tych okresów jest dłuższy, przed 1. dniem:

    1. Ogólnoustrojowe kortykosteroidy
    2. Ogólnoustrojowe leki immunosupresyjne
    3. Światłolecznictwo
    4. Doustne lub miejscowe inhibitory kinazy janusowej

  • Leczenie dowolnym z poniższych leków lub terapii w ciągu 1 tygodnia przed dniem 1:

    1. TCS
    2. TCI
    3. Miejscowe inhibitory fosfodiesterazy typu 4
    4. Inne miejscowe środki immunosupresyjne

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ramię A: Dawka 1

Część 1 (Okres początkowy); Tydzień 0 do Tydzień 24: Rocatinlimab Dawka 1 co 4 tygodnie (Q4W) przez 24 tygodnie z dawką nasycającą w Tygodniu 2 (+ miejscowe kortykosteroidy (TCS)/ miejscowy inhibitor kalcyneuryny (TCI) jeśli w kohorcie terapii skojarzonej).

Część 2 (Okres konserwacji); Tydzień 24 do Tydzień 52: Część 1 Pacjenci reagujący na leczenie zostaną ponownie przydzieleni losowo w Tygodniu 24 do grupy Rocatinlimab Dawka 1 co 4 tygodnie lub co 8 tygodni (Q8W) przez 28 tygodni (+ TCS/TCI, jeśli należą do kohorty terapii skojarzonej).
Lek: Rocatinlimab
Wstrzyknięcie podskórne (SC).
Inne nazwy:
  • AMG 451
Eksperymentalny: Ramię B: Dawka 2

Część 1 (Okres początkowy); Tydzień 0 do Tydzień 24: Rocatinlimab Dawka 2 co 4 tyg. przez 24 tygodnie z dawką nasycającą w Tygodniu 2 (+TCS/TCI, jeśli w kohorcie terapii skojarzonej).

Część 2 (Okres konserwacji); Tydzień 24 do Tydzień 52: Część 1 Pacjenci reagujący na leczenie zostaną ponownie przydzieleni losowo w Tygodniu 24 do grupy otrzymującej rokatynlimab w dawce 2 co 4 tyg. lub co 8 tyg. przez 28 tygodni (z TCS/TCI, jeśli należą do kohorty terapii skojarzonej).
Lek: Rocatinlimab
Wstrzyknięcie podskórne (SC).
Inne nazwy:
  • AMG 451
Eksperymentalny: Ramię C: Placebo

Część 1 (Okres początkowy); Tydzień 0 do Tydzień 24: Placebo Q4W przez 24 tygodnie z dawką nasycającą w Tygodniu 2 (+TCS/TCI, jeśli w kohorcie terapii skojarzonej).

Część 2 (Okres konserwacji); Tydzień 24 do Tydzień 52: Część 1 Pacjenci reagujący na leczenie zostaną ponownie przydzieleni w Tygodniu 24 z Placebo Q4W przez 28 tygodni (z TCS/TCI, jeśli należą do kohorty terapii skojarzonej).
Lek: Placebo
Wstrzyknięcie SC
Eksperymentalny: Ramię D: otwarta próba Dawka 1
Część 2; Tydzień 24 do Tydzień 52: Część 1 Osoby nieodpowiadające na leczenie zostaną ponownie przydzielone w Tygodniu 24 z Rocatinlimabem w otwartej dawce 1 co 4 tygodnie przez 28 tygodni (z TCS/TCI, jeśli należą do kohorty terapii skojarzonej). Uczestnikom grupy A, B lub C Okres leczenia podtrzymującego zostanie ponownie przydzielony do rocatinlimabu w otwartej próbie dawki 1 co 4 tyg. (z TCS/TCI, jeśli należą do kohorty terapii skojarzonej) po nawrocie po 24. tygodniu.
Lek: Rocatinlimab
Wstrzyknięcie podskórne (SC).
Inne nazwy:
  • AMG 451

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Who Achieved EASI 75 at Week 16
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amgen

Śledczy

  • Dyrektor Studium: MD, Amgen

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 kwietnia 2023

Zakończenie podstawowe (Rzeczywisty)

27 lutego 2025

Ukończenie studiów (Rzeczywisty)

25 listopada 2025

Daty rejestracji na studia

Pierwszy przesłany

20 stycznia 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 stycznia 2023

Pierwszy wysłany (Rzeczywisty)

30 stycznia 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 sierpnia 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20210145
  • 2022-501586-50 (Inny identyfikator: EUCTR)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Pozbawione elementów umożliwiających identyfikację dane poszczególnych pacjentów dla zmiennych niezbędnych do rozwiązania konkretnego pytania badawczego w zatwierdzonym wniosku o udostępnienie danych.

Ramy czasowe udostępniania IPD

Prośby o udostępnienie danych dotyczące tego badania będą rozpatrywane począwszy od 18 miesięcy po zakończeniu badania i albo 1) produkt i wskazanie uzyskały pozwolenie na dopuszczenie do obrotu zarówno w USA, jak i Europie, albo 2) badania kliniczne produktu i/lub wskazania zostały przerwane a dane nie będą przekazywane organom regulacyjnym. Nie ma ostatecznej daty kwalifikowalności do przesłania prośby o udostępnienie danych dla tego badania.

Kryteria dostępu do udostępniania IPD

Wykwalifikowani badacze mogą złożyć wniosek zawierający cele badawcze, produkt(y) firmy Amgen i badanie/badania firmy Amgen w zakresie, punkty końcowe/wyniki będące przedmiotem zainteresowania, plan analizy statystycznej, wymagania dotyczące danych, plan publikacji oraz kwalifikacje badacza(ów). Ogólnie rzecz biorąc, firma Amgen nie przyjmuje zewnętrznych próśb o dane poszczególnych pacjentów w celu ponownej oceny kwestii bezpieczeństwa i skuteczności, które zostały już uwzględnione na etykiecie produktu. Wnioski są rozpatrywane przez komitet doradców wewnętrznych. Jeśli nie zostanie to zatwierdzone, niezależny panel kontrolny ds. udostępniania danych przeprowadzi arbitraż i podejmie ostateczną decyzję. Po zatwierdzeniu informacje niezbędne do odpowiedzi na pytanie badawcze zostaną dostarczone zgodnie z warunkami umowy o udostępnianiu danych. Może to obejmować zanonimizowane dane poszczególnych pacjentów i/lub dostępne dokumenty potwierdzające, zawierające fragmenty kodu analizy, jeśli podano w specyfikacjach analizy. Dalsze szczegóły są dostępne pod poniższym adresem URL.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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