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Un estudio para evaluar rocatinlimab (AMG 451) en sujetos adolescentes con dermatitis atópica (DA) de moderada a grave (ROCKET-ASTRO)

6 de agosto de 2026 actualizado por: Amgen

Un estudio de fase 3, aleatorizado, de 52 semanas, controlado con placebo, doble ciego con realeatorización para evaluar la eficacia, la seguridad y la tolerabilidad de rocatinlimab (AMG 451) en sujetos adolescentes con dermatitis atópica (DA) de moderada a grave ( COHETE-ASTRO)

El propósito de este estudio es evaluar la eficacia y seguridad de rocatinlimab en monoterapia y tratamiento de terapia combinada en sujetos adolescentes.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

532

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bad Bentheim, Alemania, 48455
        • Fachklinik Bad Bentheim
      • Bonn, Alemania, 53127
        • Universitaetsklinikum Bonn
      • Darmstadt, Alemania, 64283
        • Rosenpark Research GmbH
      • Dresden, Alemania, 01307
        • Universitaetsklinikum Dresden
      • Erlangen, Alemania, 91054
        • Universitaetsklinikum Erlangen
      • Frankfurt am Main, Alemania, 60590
        • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
      • Leipzig, Alemania, 04103
        • Velocity Clinical Research
      • Mainz, Alemania, 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
  • Corea del Sur
      • Ansansi, Gyeonggido, Corea del Sur, 15355
        • Korea University Ansan Hospital
      • Seoul, Corea del Sur, 03080
        • Seoul National University Hospital
      • Seoul, Corea del Sur, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Corea del Sur, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Corea del Sur, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Corea del Sur, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Corea del Sur, 08308
        • Korea University Guro Hospital
      • Seoul, Corea del Sur, 06973
        • Chung-Ang University Hospital
      • Seoul, Corea del Sur, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Corea del Sur, 04564
        • National Medical Center
      • Seoul, Corea del Sur, 07804
        • Ewha Womans University Seoul Hospital
  • Croacia
      • Ivanić-Grad, Croacia, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Osijek, Croacia, 31000
        • University Hospital Centre Osijek
      • Zagreb, Croacia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Croacia, 10000
        • Sestre milosrdnice University Hospital Center
      • Zagreb, Croacia, 10000
        • Children s Hospital Zagreb
  • España
      • Madrid, España, 28046
        • Hospital Universitario La Paz
      • Madrid, España, 28007
        • Hospital General Universitario Gregorio Marañón
    • Catalonia
      • Barcelona, Catalonia, España, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Esplugues de Llobregat, Catalonia, España, 08950
        • Hospital Sant Joan de Déu
    • Navarre
      • Pamplona, Navarre, España, 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
  • Francia
      • Antony, Francia, 92160
        • Hopital Prive d Antony
      • Brest, Francia, 29200
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
      • Marseille, Francia, 13285
        • Hôpital Saint-Joseph
      • Nantes, Francia, 44093
        • Centre Hospitalier Universitaire de Nantes Hôtel Dieu
      • Rennes, Francia, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
      • Rouen, Francia, 76031
        • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
      • Toulouse, Francia, 31059
        • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
  • Grecia
      • Athens, Grecia, 11521
        • Athens Naval Hospital
      • Athens, Grecia, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Athens, Grecia, 11527
        • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
      • Thessaloniki, Grecia, 54643
        • Ippokratio General Hospital of Thessaloniki
  • Hungría
      • Budapest, Hungría, 1033
        • Clinexpert Kft
      • Debrecen, Hungría, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hungría, 4031
        • Derma-B Egeszsegugyi es Szolgaltato Kft
      • Kaposvár, Hungría, 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
  • Italia
      • Milan, Italia, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Naples, Italia, 80131
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
      • Perugia, Italia, 06129
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Torino, Italia, 10126
        • Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • Japón
    • Aichi-ken
      • Nagoya, Aichi-ken, Japón, 464-0821
        • Central Clinic
    • Chiba
      • Matsudo-shi, Chiba, Japón, 271-0092
        • Miyata Dermatology Clinic
    • Fukuoka
      • Fukuoka, Fukuoka, Japón, 819-0373
        • Matsuo Clinic
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japón, 070-8610
        • Asahikawa City Hospital
      • Obihiro-shi, Hokkaido, Japón, 080-0013
        • Takagi Dermatological Clinic
    • Hyōgo
      • Akashi-shi, Hyōgo, Japón, 674-0068
        • Yoshimura Child Clinic
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japón, 890-0063
        • Katahira Dermatology Urology Clinic
    • Kanagawa
      • Yokohama, Kanagawa, Japón, 231-8682
        • Yokohama City Minato Red Cross Hospital
      • Yokohama, Kanagawa, Japón, 221-0825
        • Nomura Dermatology Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japón, 860-0066
        • Jouzan Hihuka Hinyoukika Clinic
      • Kumamoto, Kumamoto, Japón, 862-0950
        • Suizenji Dermatology Clinic
    • Osaka
      • Neyagawa, Osaka, Japón, 572-0838
        • Yoshioka Dermatology Clinic
      • Sakai-shi, Osaka, Japón, 593-8324
        • Dermatology and Ophthalmology Kume Clinic
    • Shizuoka
      • Hamamatsu, Shizuoka, Japón, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Setagaya-ku, Tokyo, Japón, 158-0097
        • Naoko Dermatology Clinic
      • Shinagawa-ku, Tokyo, Japón, 141-8625
        • NTT Medical Center Tokyo
  • México
      • Toluca, México, 50090
        • Phylasis Clinicas Research Toluca
  • Polonia
      • Gdansk, Polonia, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk, Polonia, 80-280
        • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
      • Katowice, Polonia, 40-611
        • Centrum Medyczne Angelius Provita
      • Katowice, Polonia, 40-600
        • GynCentrum Sp zoo NZOZ Holsamed
      • Krakow, Polonia, 30-002
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
      • Krakow, Polonia, 31-559
        • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
      • Lodz, Polonia, 90-349
        • AppleTreeClinics Network Spzoo
      • Lodz, Polonia, 91-495
        • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
      • Lublin, Polonia, 20-011
        • Clinical Best Solutions Sp zoo Spolka komandytowa
      • Sosnowiec, Polonia, 41-200
        • Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
      • Tarnów, Polonia, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
      • Warsaw, Polonia, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Polonia, 02-953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Polonia, 00-716
        • Klinika Osipowicz and Turkowski Sp zoo
      • Warsaw, Polonia, 01-817
        • High Med Przychodnia Specjalistyczna
      • Wroclaw, Polonia, 50-450
        • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
  • Porcelana
      • Changsha, Porcelana, 410007
        • Hunan Childrens Hospital
      • Shenzhen, Porcelana, 518038
        • Shenzhen Childrens Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, Porcelana, 100020
        • Childrens Hospital Capital Institute of Pediatrics
      • Beijing, Beijing Municipality, Porcelana, 100044
        • Peking University Peoples Hospital
      • Beijing, Beijing Municipality, Porcelana, 100045
        • Beijing Childrens Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Porcelana, 400014
        • Childrens Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510091
        • Dermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, Porcelana, 510120
        • Sun Yat-sen Memorial Hospital Sun Yat-sen university
      • Guangzhou, Guangdong, Porcelana, 510080
        • The First Affiliated Hospital Sun-Yat Sen University
    • Henan
      • Nanyang, Henan, Porcelana, 473002
        • Nanyang First Peoples Hospital
    • Hubei
      • Wuhan, Hubei, Porcelana, 430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Wuhan, Hubei, Porcelana, 430014
        • The Central Hospital of Wuhan
    • Jiangsu
      • Jiangyin, Jiangsu, Porcelana, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
    • Jilin
      • Changchun, Jilin, Porcelana, 130021
        • The First Bethune Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, Porcelana, 116011
        • Dalian Women and Childrens Medical Group
    • Ningxia
      • Yinchuan, Ningxia, Porcelana, 750003
        • General Hospital of Ningxia Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200443
        • Shanghai Skin Disease Hospital
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610021
        • Chengdu Second Peoples Hospital
      • Suining, Sichuan, Porcelana, 629099
        • Suining Central Hospital
    • Yunnan
      • Kunming, Yunnan, Porcelana, 650103
        • Kunming Childrens Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310020
        • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
      • Ningbo, Zhejiang, Porcelana, 315010
        • Ningbo NO 2 Hospital
      • Taizhou, Zhejiang, Porcelana, 318000
        • Taizhou Central Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC
      • San Juan, Puerto Rico, 00909
        • Clinical Research of Puerto Rico
  • Rumania
      • Bucharest, Rumania, 011216
        • Dr Leventer Centre Clinica Dermatologie Bucuresti
      • Cluj-Napoca, Rumania, 400431
        • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
      • Cluj-Napoca, Rumania, 400105
        • Derma Cluj
  • Tailandia
      • Bangkok, Tailandia, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Tailandia, 10700
        • Siriraj Hospital
      • Chiang Mai, Tailandia, 50200
        • Maharaj Nakorn Chiang Mai Hospital
      • Pathum Thani, Tailandia, 12120
        • Thammasat University Hospital
  • Taiwán
      • Kaohsiung City, Taiwán, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwán, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwán, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwán, 33305
        • Linkou Chang Gung Memorial Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 17 años (Niño)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Edad ≥ 12 a < 18 años en el Día 1.
  • Peso corporal ≥ 40 kg en la selección.
  • Historial de respuesta inadecuada a TCS de potencia media o alta dentro de los 6 meses (con o sin TCI).
  • Puntuación EASI ≥ 16.
  • Puntuación vIGA-AD ≥ 3.
  • ≥10% del área de superficie corporal (BSA) de compromiso de AD.
  • Peor prurito NRS ≥ 4.

Criterio de exclusión:

  • Tratamiento con un producto biológico dentro de las 12 semanas o 5 semividas, lo que sea más largo, antes del Día 1.

  • Tratamiento con cualquiera de los siguientes medicamentos o terapias dentro de las 4 semanas o 5 semividas, lo que sea más largo, antes del Día 1:

    1. corticosteroides sistémicos
    2. Inmunosupresores sistémicos
    3. Fototerapia
    4. Inhibidores orales o tópicos de la quinasa Janus

  • Tratamiento con cualquiera de los siguientes medicamentos o terapias dentro de 1 semana, antes del Día 1:

    1. TCS
    2. TCI
    3. Inhibidores tópicos de la fosfodiesterasa tipo 4
    4. Otros agentes inmunosupresores tópicos

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Brazo A: Dosis 1

Parte 1 (Período Inicial); Semana 0 a Semana 24: Rocatinlimab Dosis 1 cada 4 semanas (Q4W) durante 24 semanas con dosis de carga en la Semana 2 (+ corticosteroides tópicos (TCS)/inhibidor de calcineurina tópico (TCI) si está dentro de la cohorte de terapia combinada).

Parte 2 (Período de mantenimiento); Semana 24 a Semana 52: Los respondedores de la Parte 1 serán reasignados aleatoriamente en la Semana 24 a Rocatinlimab Dosis 1 Q4W o cada 8 semanas (Q8W) durante 28 semanas (+ TCS/TCI si está dentro de la cohorte de terapia combinada).
Droga: Rocatinlimab
Inyección subcutánea (SC)
Otros nombres:
  • AMG 451
Experimental: Brazo B: Dosis 2

Parte 1 (Período Inicial); Semana 0 a Semana 24: Rocatinlimab Dosis 2 Q4W durante 24 semanas con dosis de carga en la Semana 2 (+TCS/TCI si está dentro de la cohorte de terapia combinada).

Parte 2 (Período de mantenimiento); Semana 24 a Semana 52: Los respondedores de la Parte 1 serán reasignados aleatoriamente en la Semana 24 a Rocatinlimab Dosis 2 Q4W o Q8W durante 28 semanas (con TCS/TCI si están dentro de la cohorte de terapia combinada).
Droga: Rocatinlimab
Inyección subcutánea (SC)
Otros nombres:
  • AMG 451
Experimental: Brazo C: Placebo

Parte 1 (Período Inicial); Semana 0 a Semana 24: Placebo Q4W durante 24 semanas con dosis de carga en la Semana 2 (+TCS/TCI si está dentro de la cohorte de terapia combinada).

Parte 2 (Período de mantenimiento); Semana 24 a Semana 52: Los respondedores de la Parte 1 serán reasignados en la Semana 24 con Placebo Q4W durante 28 semanas (con TCS/TCI si están dentro de la cohorte de terapia combinada).
Droga: Placebo
Inyección SC
Experimental: Brazo D: Dosis 1 de etiqueta abierta
Parte 2; De la semana 24 a la semana 52: las personas que no respondieron a la Parte 1 serán reasignadas en la semana 24 con Rocatinlimab de etiqueta abierta en dosis 1 Q4W durante 28 semanas (con TCS/TCI si están dentro de la cohorte de terapia combinada). Los participantes en el Período de mantenimiento de los Brazos A, B o C serán reasignados con Rocatinlimab de etiqueta abierta, Dosis 1 Q4W (con TCS/TCI si está dentro de la cohorte de terapia combinada) tras la recaída después de la Semana 24.
Droga: Rocatinlimab
Inyección subcutánea (SC)
Otros nombres:
  • AMG 451

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Who Achieved EASI 75 at Week 16
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Amgen

Investigadores

  • Director de estudio: MD, Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de abril de 2023

Finalización primaria (Actual)

27 de febrero de 2025

Finalización del estudio (Actual)

25 de noviembre de 2025

Fechas de registro del estudio

Enviado por primera vez

20 de enero de 2023

Primero enviado que cumplió con los criterios de control de calidad

20 de enero de 2023

Publicado por primera vez (Actual)

30 de enero de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20210145
  • 2022-501586-50 (Otro identificador: EUCTR)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Datos de pacientes individuales desidentificados para las variables necesarias para abordar la pregunta de investigación específica en una solicitud de intercambio de datos aprobada.

Marco de tiempo para compartir IPD

Las solicitudes de intercambio de datos relacionadas con este estudio se considerarán a partir de los 18 meses posteriores a la finalización del estudio y 1) el producto y la indicación han obtenido la autorización de comercialización tanto en los EE. UU. como en Europa o 2) el desarrollo clínico del producto y/o la indicación se interrumpe y los datos no se enviarán a las autoridades reguladoras. No hay una fecha límite para la elegibilidad para enviar una solicitud de intercambio de datos para este estudio.

Criterios de acceso compartido de IPD

Los investigadores calificados pueden enviar una solicitud que contenga los objetivos de la investigación, los productos de Amgen y el alcance de los estudios de Amgen, criterios de valoración/resultados de interés, plan de análisis estadístico, requisitos de datos, plan de publicación y calificaciones de los investigadores. En general, Amgen no concede solicitudes externas de datos de pacientes individuales con el fin de reevaluar los problemas de seguridad y eficacia ya abordados en la etiqueta del producto. Las solicitudes son revisadas por un comité de asesores internos. Si no se aprueba, un Panel de Revisión Independiente de Intercambio de Datos arbitrará y tomará la decisión final. Tras la aprobación, la información necesaria para abordar la pregunta de investigación se proporcionará bajo los términos de un acuerdo de intercambio de datos. Esto puede incluir datos de pacientes individuales anonimizados y/o documentos de respaldo disponibles, que contengan fragmentos de código de análisis donde se proporcione en las especificaciones de análisis. Más detalles están disponibles en la siguiente URL.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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