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Um estudo para avaliar o rocatinlimabe (AMG 451) em adolescentes com dermatite atópica (DA) moderada a grave (ROCKET-ASTRO)

6 de agosto de 2026 atualizado por: Amgen

Um estudo de fase 3, randomizado, de 52 semanas, controlado por placebo, duplo-cego com rerandomização para avaliar a eficácia, segurança e tolerabilidade de Rocatinlimabe (AMG 451) em adolescentes com dermatite atópica (DA) moderada a grave ( ROCKET-ASTRO)

O objetivo deste estudo é avaliar a eficácia e segurança de rocatinlimabe em monoterapia e tratamento de terapia combinada em adolescentes.

Visão geral do estudo

Status

Concluído

Condições

Dermatite atópica

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

532

Estágio

Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 17 anos (Filho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

Idade ≥ 12 a < 18 anos no Dia 1.
Peso corporal ≥ 40 kg na triagem.
História de resposta inadequada a TCS de média ou alta potência em 6 meses (com ou sem TCI).
Pontuação EASI ≥ 16.
Pontuação vIGA-AD ≥ 3.
≥10% da área de superfície corporal (ASC) de envolvimento da DA.
Pior prurido NRS ≥ 4.

Critério de exclusão:

Tratamento com um produto biológico dentro de 12 semanas ou 5 meias-vidas, o que for mais longo, antes do Dia 1.
Tratamento com qualquer um dos seguintes medicamentos ou terapias dentro de 4 semanas ou 5 meias-vidas, o que for mais longo, antes do Dia 1:
1. Corticosteróides sistêmicos
2. Imunossupressores sistêmicos
3. Fototerapia
4. Inibidores orais ou tópicos da Janus quinase
Tratamento com qualquer um dos seguintes medicamentos ou terapias dentro de 1 semana, antes do Dia 1:
1. TCS
2. TCI
3. Inibidores tópicos da fosfodiesterase tipo 4
4. Outros agentes imunossupressores tópicos

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição sequencial
Mascaramento: Dobro

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: Braço A: Dose 1 Parte 1 (Período Inicial); Semana 0 a Semana 24: Rocatinlimabe Dose 1 a cada 4 semanas (Q4W) por 24 semanas com dose de ataque na Semana 2 (+ corticosteroides tópicos (TCS)/inibidor tópico de calcineurina (TCI) se dentro da coorte de terapia combinada). Parte 2 (Período de Manutenção); Semana 24 a Semana 52: Os respondedores da Parte 1 serão randomizados novamente na Semana 24 para Dose 1 de Rocatinlimabe Q4W ou a cada 8 semanas (Q8W) por 28 semanas (+ TCS/TCI se dentro da coorte de terapia combinada).	Medicamento: Rocatinlimabe Injeção subcutânea (SC) Outros nomes: AMG 451
Experimental: Braço B: Dose 2 Parte 1 (Período Inicial); Semana 0 a Semana 24: Rocatinlimabe Dose 2 Q4W por 24 semanas com dose de ataque na Semana 2 (+TCS/TCI se dentro da coorte de terapia combinada). Parte 2 (Período de Manutenção); Semana 24 a Semana 52: Os respondedores da Parte 1 serão randomizados novamente na Semana 24 para Rocatinlimabe Dose 2 Q4W ou Q8W por 28 semanas (com TCS/TCI se dentro da coorte de terapia combinada).	Medicamento: Rocatinlimabe Injeção subcutânea (SC) Outros nomes: AMG 451
Experimental: Braço C: Placebo Parte 1 (Período Inicial); Semana 0 a Semana 24: Placebo Q4W por 24 semanas com dose de ataque na Semana 2 (+TCS/TCI se dentro da coorte de terapia combinada). Parte 2 (Período de Manutenção); Semana 24 a Semana 52: Os respondedores da Parte 1 serão reatribuídos na Semana 24 com Placebo Q4W por 28 semanas (com TCS/TCI se dentro da coorte de terapia combinada).	Medicamento: Placebo Injeção SC
Experimental: Braço D: Dose aberta 1 Parte 2; Semana 24 a Semana 52: Os não respondedores da Parte 1 serão reatribuídos na Semana 24 com Rocatinlimabe Dose Aberta 1 Q4W por 28 semanas (com TCS/TCI se dentro da coorte de terapia combinada). Os participantes no Período de Manutenção dos Grupos A, B ou C serão reatribuídos com Rocatinlimabe Dose Aberta 1 Q4W (com TCS/TCI se dentro da coorte de terapia combinada) mediante recaída após a Semana 24.	Medicamento: Rocatinlimabe Injeção subcutânea (SC) Outros nomes: AMG 451

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
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 Prazo: 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 Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Number of Participants Who Achieved EASI 75 at Week 16 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Amgen

Investigadores

Diretor de estudo: MD, Amgen

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

AmgenTrials clinical trials website

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de abril de 2023

Conclusão Primária (Real)

27 de fevereiro de 2025

Conclusão do estudo (Real)

25 de novembro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

20 de janeiro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de janeiro de 2023

Primeira postagem (Real)

30 de janeiro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

20210145
2022-501586-50 (Outro identificador: EUCTR)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Dados de pacientes individuais não identificados para variáveis necessárias para abordar a questão de pesquisa específica em uma solicitação de compartilhamento de dados aprovada.

Prazo de Compartilhamento de IPD

As solicitações de compartilhamento de dados relacionadas a este estudo serão consideradas a partir de 18 meses após o término do estudo e 1) o produto e a indicação receberam autorização de comercialização nos EUA e na Europa ou 2) o desenvolvimento clínico do produto e/ou indicação foi descontinuado e os dados não serão submetidos a autoridades reguladoras. Não há data final para elegibilidade para enviar uma solicitação de compartilhamento de dados para este estudo.

Critérios de acesso de compartilhamento IPD

Os pesquisadores qualificados podem enviar uma solicitação contendo os objetivos da pesquisa, o(s) produto(s) da Amgen e estudo/estudos da Amgen em escopo, parâmetros/resultados de interesse, plano de análise estatística, requisitos de dados, plano de publicação e qualificações do(s) pesquisador(es). Em geral, a Amgen não atende a solicitações externas de dados individuais de pacientes com a finalidade de reavaliar questões de segurança e eficácia já abordadas na rotulagem do produto. As solicitações são analisadas por um comitê de consultores internos. Se não for aprovado, um Painel de Revisão Independente de Compartilhamento de Dados arbitrará e tomará a decisão final. Após a aprovação, as informações necessárias para abordar a questão da pesquisa serão fornecidas sob os termos de um acordo de compartilhamento de dados. Isso pode incluir dados anônimos de pacientes individuais e/ou documentos de suporte disponíveis, contendo fragmentos de código de análise quando fornecidos nas especificações de análise. Mais detalhes estão disponíveis no URL abaixo.

Tipo de informação de suporte de compartilhamento de IPD

PROTOCOLO DE ESTUDO
SEIVA
CIF
CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Um estudo para avaliar o rocatinlimabe (AMG 451) em adolescentes com dermatite atópica (DA) moderada a grave (ROCKET-ASTRO)

Um estudo de fase 3, randomizado, de 52 semanas, controlado por placebo, duplo-cego com rerandomização para avaliar a eficácia, segurança e tolerabilidade de Rocatinlimabe (AMG 451) em adolescentes com dermatite atópica (DA) moderada a grave ( ROCKET-ASTRO)

Visão geral do estudo

Status

Condições

Intervenção / Tratamento

Tipo de estudo

Inscrição (Real)

Estágio

Contactos e Locais

Locais de estudo

Critérios de participação

Critérios de elegibilidade

Idades elegíveis para estudo

Aceita Voluntários Saudáveis

Descrição

Plano de estudo

Como o estudo é projetado?

Detalhes do projeto

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço

Intervenção / Tratamento

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado

Descrição da medida

Prazo

Medidas de resultados secundários

Medida de resultado

Descrição da medida

Prazo

Colaboradores e Investigadores

Patrocinador

Investigadores

Publicações e links úteis

Publicações Gerais

Links úteis

Datas de registro do estudo

Datas Principais do Estudo

Início do estudo (Real)

Conclusão Primária (Real)

Conclusão do estudo (Real)

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez que atendeu aos critérios de CQ

Primeira postagem (Real)

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última verificação

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Descrição do plano IPD

Prazo de Compartilhamento de IPD

Critérios de acesso de compartilhamento IPD

Tipo de informação de suporte de compartilhamento de IPD

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Estuda um produto de dispositivo regulamentado pela FDA dos EUA