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Um estudo avaliando o rocatinlimabe na dermatite atópica moderada a grave (ROCKET-IGNITE) (ROCKET-Ignite)

25 de junho de 2026 atualizado por: Amgen

Um estudo de Fase 3, 24 semanas, randomizado, controlado por placebo, duplo-cego para avaliar a eficácia, segurança e tolerabilidade da monoterapia com Rocatinlimabe (AMG 451) em indivíduos adultos com dermatite atópica (DA) moderada a grave

O objetivo deste estudo é avaliar a eficácia e segurança do rocatinlimabe no tratamento em monoterapia.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

769

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
      • Berlin, Alemanha, 10117
        • Charite - Universitaetsmedizin Berlin, Campus Mitte
      • Blankenfelde-Mahlow, Alemanha, 15831
        • Dermatologische Gemeinschaftspraxis-Mahlow
      • Bochum, Alemanha, 44793
        • Hautarztpraxis Dr Niesmann und Dr Othlinghaus
      • Darmstadt, Alemanha, 64283
        • Rosenpark Research GmbH
      • Dresden, Alemanha, 01307
        • Universitaetsklinikum Dresden
      • Düsseldorf, Alemanha, 40225
        • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
      • Essen, Alemanha, 45174
        • Universitaetsklinikum Essen
      • Hamburg, Alemanha, 20246
        • Institute for Health Services Research in Dermatology and Nursing
      • Heidelberg, Alemanha, 69120
        • Universitaetsklinikum Heidelberg
      • Stuttgart, Alemanha, 70178
        • Hautarztpraxis Dres Leitz und Kollegen
      • Tübingen, Alemanha, 72076
        • Universitaetsklinikum Tuebingen
      • Wuppertal, Alemanha, 42287
        • CentroDerm GmbH
  • Argentina
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1027AAP
        • CINME - Centro De Investigaciones Metabolicas
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
        • Fundacion Respirar
      • Derqui, Pilar, Buenos Aires, Argentina, B1629ODT
        • Hospital Universitario Austral
      • San Miguel, Buenos Aires, Argentina, 1663
        • Centro Dermatologico Schejtman
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, 1425
        • Instituto de Neumonología Y Dermatología
      • Buenos Aires, Distrito Federal, Argentina, 1425
        • InAER - Investigaciones en Alergia y Enfermedades Respiratorias
      • CABA, Distrito Federal, Argentina, C1012AAY
        • Conexa Investigacion Clinica SA
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Fundacion Estudios Clinicos
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto de Diagnostico Abc American British Cowdray
  • Brasil
      • Rio de Janeiro, Brasil, 20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
      • São Paulo, Brasil, 06454-010
        • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasil, 90160-093
        • Hospital Ernesto Dornelles
    • São Paulo
      • Botucatu, São Paulo, Brasil, 18618-686
        • Upeclin-Pesq Clin FacMed Botucatu
      • Santo André, São Paulo, Brasil, 09060-870
        • Fundacao Abc - Centro Univ Fmabc
      • Santo André, São Paulo, Brasil, 09030-010
        • Hosp e Maternidade Dr Christovao da Gama
      • Sorocaba, São Paulo, Brasil, 18040-425
        • Consultoria Medica e Pesquisa Clinica Cmpc
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1C3
        • Alberta Derma Surgery Centre
      • Edmonton, Alberta, Canadá, T6H 4J8
        • Vida Clinical Research
    • Ontario
      • Ajax, Ontario, Canadá, L1S 7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, Canadá, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, Canadá, L8L 3C3
        • Leader Research
      • Mississauga, Ontario, Canadá, L4Y 4C5
        • DermEdge Research Incorporated
      • North York, Ontario, Canadá, M3B 3S6
        • Gordon Sussman Clinical Research Incorporated
      • North York, Ontario, Canadá, M3B 0A7
        • Canadian Dermatology Centre
      • Richmond Hill, Ontario, Canadá, L4E 4L6
        • Oak Ridges Aesthetics Centre
    • Quebec
      • Montreal, Quebec, Canadá, H2X 2V1
        • Innovaderm Research Inc
      • Québec, Quebec, Canadá, G1G 3Y8
        • Recherche Clinique Sigma Incorporated
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canadá, S7K 2C1
        • Skinsense Medical Research
  • China
      • Beijing, China, 100044
        • Peking University Peoples Hospital
      • Shanghai, China, 200443
        • Shanghai Skin Disease Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • The First Affiliated Hospital of Fujian 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
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University
    • Henan
      • Nanyang, Henan, China, 473002
        • Nanyang First Peoples Hospital
      • Sanmenxia, Henan, China, 472099
        • Sanmenxia Central Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410011
        • The second Xiangya Hospital of Central South University
    • Jiangsu
      • Jiangyin, Jiangsu, China, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
      • Wuxi, Jiangsu, China, 241023
        • Wuxi Peoples Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Dermatology Hospital of Jiangxi Province
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610021
        • Chengdu Second Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • the First Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310020
        • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310004
        • Zhejiang Provincial Peoples Hospital
      • Taizhou, Zhejiang, China, 318000
        • Taizhou Central Hospital
  • Coréia do Sul
      • Ansansi, Gyeonggido, Coréia do Sul, 15355
        • Korea University Ansan Hospital
      • Incheon, Coréia do Sul, 21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Seoul, Coréia do Sul, 03080
        • Seoul National University Hospital
      • Seoul, Coréia do Sul, 05505
        • Asan Medical Center
      • Seoul, Coréia do Sul, 08308
        • Korea University Guro Hospital
      • Seoul, Coréia do Sul, 04564
        • National Medical Center
  • Croácia
      • Ivanić-Grad, Croácia, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Zagreb, Croácia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Croácia, 10000
        • Sestre milosrdnice University Hospital Center
  • Eslováquia
      • Banská Bystrica, Eslováquia, 975 17
        • Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
      • Bratislava, Eslováquia, 851 01
        • Derma therapy, spol s ro
      • Svidník, Eslováquia, 089 01
        • Sanare spol sro
      • Topoľčany, Eslováquia, 955 01
        • Kaderma Majtan, sro
      • Trnava, Eslováquia, 917 75
        • Fakultna Nemocnica Trnava
  • Espanha
      • Madrid, Espanha, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Espanha, 28031
        • Hospital Universitario Infanta Leonor
    • Andalusia
      • Córdoba, Andalusia, Espanha, 14004
        • Hospital Universitario Reina Sofia
    • Aragon
      • Zaragoza, Aragon, Espanha, 50009
        • Hospital Universitario Miguel Servet
    • Canary Islands
      • Las Palmas de Gran Canaria, Canary Islands, Espanha, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
    • Catalonia
      • Badalona, Catalonia, Espanha, 08916
        • Hospital Universitari Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Catalonia, Espanha, 08907
        • Hospital Universitari de Bellvitge
    • Galicia
      • Pontevedra, Galicia, Espanha, 36001
        • Hospital Clínico Universitario de Santiago
    • Madrid
      • Pozuelo de Alarcón, Madrid, Espanha, 28223
        • Hospital Universitario Quironsalud Madrid
    • Valencia
      • Valencia, Valencia, Espanha, 46026
        • Hospital Universitari i Politecnic La Fe
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35244
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85032
        • Alliance Dermatology and Mohs Center
    • California
      • Anaheim, California, Estados Unidos, 92801
        • Anaheim Clinical Trials
      • Fountain Valley, California, Estados Unidos, 92708
        • First OC Dermatology
      • Glendale, California, Estados Unidos, 91203
        • Kaiser Permanente - Glendale Medical Center
      • Long Beach, California, Estados Unidos, 90805
        • Long Beach Research Institute
      • Los Angeles, California, Estados Unidos, 90045
        • Dermatology Research Associates
      • Los Angeles, California, Estados Unidos, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Sherman Oaks, California, Estados Unidos, 91403
        • Cura Clinical Research
    • Colorado
      • Centennial, Colorado, Estados Unidos, 80112
        • IMMUNOe Research Centers
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Skin Care Research Incorporated
      • Delray Beach, Florida, Estados Unidos, 33484
        • Palm Beach Dermatology Group
      • Homestead, Florida, Estados Unidos, 33030
        • Global Research Associates
      • Miami, Florida, Estados Unidos, 33175
        • Healthy Life Research
      • Miami Lakes, Florida, Estados Unidos, 33014
        • Savin Medical Group LLC
      • Naples, Florida, Estados Unidos, 34102
        • Kirsch Dermatology LLC
      • Orlando, Florida, Estados Unidos, 32819
        • Pure Skin Dermatology and Aesthetics
      • St. Petersburg, Florida, Estados Unidos, 33709
        • Industrial Medicine Associates Ima Clinical Research Inc
      • Tampa, Florida, Estados Unidos, 33606
        • Genesis Clinical Research LLC
    • Idaho
      • Boise, Idaho, Estados Unidos, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • DeNova Research
      • West Dundee, Illinois, Estados Unidos, 60118
        • Dundee Dermatology
    • Indiana
      • Plainfield, Indiana, Estados Unidos, 46168
        • The Indiana Clinical Trials Center PC
    • Maryland
      • Chevy Chase, Maryland, Estados Unidos, 20815
        • Institute for Asthma and Allergy
      • Towson, Maryland, Estados Unidos, 21204
        • Continental Clinical Solutions, LLC
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Health System
      • Flint, Michigan, Estados Unidos, 48532
        • Onyx Clinical Research
    • Missouri
      • Lee's Summit, Missouri, Estados Unidos, 64064
        • Dermatology and Skin Cancer Center of Lees Summit
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • Jubilee Clinical Research Inc
    • New Hampshire
      • Portsmouth, New Hampshire, Estados Unidos, 03801
        • Allcutis Research, Llc - Portsmouth
    • New Jersey
      • Cherry Hill, New Jersey, Estados Unidos, 08034
        • Continental Clinical Solutions - Cherry Hill
    • New York
      • Hartsdale, New York, Estados Unidos, 10530
        • Industrial Medicine Associates Ima Clinical Research Inc
      • New York, New York, Estados Unidos, 10075
        • Sadick Research Group
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28277
        • Dermatology Specialists of Charlotte
      • Charlotte, North Carolina, Estados Unidos, 28277
        • Onsite Clinical Solutions
      • Wilmington, North Carolina, Estados Unidos, 28405
        • Wilmington Dermatology Center
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • The Skin Surgery Center for Clinical Research
    • Ohio
      • Boardman, Ohio, Estados Unidos, 44512
        • Optima Research
      • Columbus, Ohio, Estados Unidos, 43213
        • ClinOhio Research Services
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, Estados Unidos, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Estados Unidos, 74137
        • Essential Medical Research LLC
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Sugarloaf, Pennsylvania, Estados Unidos, 18249
        • DermDox Dermatology, LLC
    • Tennessee
      • Hermitage, Tennessee, Estados Unidos, 37076
        • Cumberland Skin Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75230
        • Dermatology Treatment and Research Center PA
      • The Woodlands, Texas, Estados Unidos, 77380
        • The Woodlands Dermatology Associates
    • Virginia
      • Lynchburg, Virginia, Estados Unidos, 24501
        • Education and Research Foundation Inc
    • Washington
      • Mill Creek, Washington, Estados Unidos, 98012
        • Frontier Derm Partners
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26505
        • West Virginia Research Institute
  • Grécia
      • Athens, Grécia, 12462
        • University General Hospital Attikon
      • Athens, Grécia, 11521
        • Athens Naval Hospital
      • Athens, Grécia, 16121
        • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
      • Athens, Grécia, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Ioannina, Grécia, 45500
        • University General Hospital of Ioannina
      • Larissa, Grécia, 41110
        • General University Hospital of Larissa
      • Thessaloniki, Grécia, 56403
        • Papageorgiou General Hospital
  • Holanda
      • Born, Holanda, 6121 XK
        • PreCare Trial and Recruitment
  • Hungria
      • Veszprém, Hungria, 8200
        • MedMare Bt
  • Itália
      • Chieti, Itália, 66100
        • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
      • Milan, Itália, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Perugia, Itália, 06156
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Roma, Itália, 00161
        • Azienda Ospedaliera Policlinico Umberto I
      • Torino, Itália, 10126
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
  • Japão
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japão, 480-1195
        • Aichi Medical University Hospital
      • Nagoya, Aichi-ken, Japão, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Aichi-ken, Japão, 464-0821
        • Central Clinic
      • Nagoya, Aichi-ken, Japão, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japão, 819-0373
        • Matsuo Clinic
      • Fukuoka, Fukuoka, Japão, 814-0180
        • Fukuoka University Hospital
    • Fukushima
      • Fukushima, Fukushima, Japão, 960-1295
        • Fukushima Medical University Hospital
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japão, 070-8610
        • Asahikawa City Hospital
    • Ibaraki
      • Inashiki-gun, Ibaraki, Japão, 300-0395
        • Tokyo Medical University Ibaraki Medical Center
    • Ishikawa-ken
      • Nonoichi-shi, Ishikawa-ken, Japão, 921-8801
        • Kaji Dermatology Clinic
    • Iwate
      • Morioka, Iwate, Japão, 020-8505
        • Iwate Medical University Uchimaru Medical Center
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Japão, 763-0074
        • Takeoka Dermatology Clinic
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japão, 211-8533
        • Nippon Medical School Musashikosugi Hospital
    • Kyoto
      • Kyoto, Kyoto, Japão, 607-8062
        • Rakuwakai Otowa Hospital
      • Kyoto, Kyoto, Japão, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
    • Osaka
      • Izumiotsu-shi, Osaka, Japão, 595-0025
        • Mochida Dermatology Clinic
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japão, 321-0293
        • Dokkyo Medical University Hospital
    • Tokyo
      • Itabashi-ku, Tokyo, Japão, 173-8610
        • Nihon University Itabashi Hospital
      • Itabashi-ku, Tokyo, Japão, 173-8606
        • Teikyo University Hospital
  • Letônia
      • Riga, Letônia, 1003
        • Outpatient clinic Veselibas Centrs 4
      • Riga, Letônia, LV-1013
        • Outpatient clinic Veselibascentrs 4
      • Talsi, Letônia, 3201
        • Smite Aija practice in dermatology and venerology
  • Polônia
      • Gdansk, Polônia, 80-280
        • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
      • Katowice, Polônia, 40-611
        • Centrum Medyczne Angelius Provita
      • Lublin, Polônia, 20-080
        • Centrum Zdrowia i Urody Maxxmed
      • Malbork, Polônia, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
      • Nowa Sól, Polônia, 67-100
        • Twoja Przychodnia NCM
      • Poznan, Polônia, 61-293
        • Twoja Przychodnia PCM
      • Szczecin, Polônia, 71-500
        • Twoja Przychodnia SCM
      • Tarnów, Polônia, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
      • Warsaw, Polônia, 02-962
        • Royalderm Agnieszka Nawrocka
      • Wroclaw, Polônia, 50-450
        • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
  • Porto Rico
      • San Juan, Porto Rico, 00909
        • Clinical Research of Puerto Rico
  • Portugal
      • Lisbon, Portugal, 1998-018
        • Hospital CUF Descobertas
      • Lisbon, Portugal, 1500-458
        • Hospital Lusíadas Lisboa
      • Matosinhos Municipality, Portugal, 4464-513
        • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
      • Porto, Portugal, 4099-001
        • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10449
        • MacKay Memorial Hospital Taipei Branch
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
  • Tcheca
      • Náchod, Tcheca, 547 01
        • Dermamedica, sro
      • Ostrava, Tcheca, 702 00
        • CCR Ostrava sro
      • Pardubice, Tcheca, 530 02
        • Pratia Pardubice as
      • Prague, Tcheca, 180 81
        • Fakultni nemocnice Bulovka
      • Prague, Tcheca, 100 00
        • Clintrial sro
      • Prague, Tcheca, 130 00
        • Pratia Prague sro
      • Ústí nad Labem, Tcheca, 401 13
        • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz

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

18 anos a 100 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Idade ≥ 18 anos com diagnóstico de DA de acordo com os critérios de consenso da AAD (2014) presente há pelo menos 6 meses
  • História de resposta inadequada a TCS (corticosteróide tópico) de média ou alta potência em 6 meses (com ou sem inibidores tópicos de calcineurina [TCI])
  • Pontuação EASI ≥16
  • pontuação viGA-AD ≥3
  • ≥10% da área de superfície corporal (ASC) de envolvimento da DA
  • Escala numérica de pior prurido ≥ 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:

    • Corticosteróides sistêmicos
    • Imunossupressores sistêmicos
    • Fototerapia
    • Inibidores de Janus quinase

  • Tratamento com qualquer um dos seguintes medicamentos ou terapias dentro de 1 semana, antes do Dia 1:

    • TCS de qualquer potência
    • TCI
    • Medicamento antipruriginoso
    • Inibidores tópicos da fosfodiesterase tipo 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 Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Braço A
Rocatinlimabe Dose 1 a cada 4 semanas (Q4W) + dose de ataque na Semana 2
Medicamento: Rocatinlimabe
Os participantes receberão Rocatinlimabe por via subcutânea.
Outros nomes:
  • AMG 451
Experimental: Braço B
Rocatinlimabe Dose 2 Q4W + dose de ataque na Semana 2
Medicamento: Rocatinlimabe
Os participantes receberão Rocatinlimabe por via subcutânea.
Outros nomes:
  • AMG 451
Comparador de Placebo: Braço C
Placebo Q4W+ dose de carga na Semana 2
Medicamento: Placebo
Os participantes receberão um placebo por via subcutânea.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (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," the participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, the 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 ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (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 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. 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 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 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
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (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 Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Prazo: Baseline and Week 24
The severity of facial AD was assessed using the Facial AD Severity Scale (FASS). The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Prazo: Baseline and Week 24
The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS). The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and 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 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 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 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 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 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 adult 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
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 adult 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
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 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 a greater impact of AD. 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 a greater impact of AD. 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 impact of AD.
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 a greater impact of AD. 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 impact of AD.
Baseline and Week 24
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
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily 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 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
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
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. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
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 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 a greater impact of AD. 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

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

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)

31 de maio de 2022

Conclusão Primária (Real)

28 de novembro de 2024

Conclusão do estudo (Real)

13 de janeiro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

24 de maio de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de maio de 2022

Primeira postagem (Real)

1 de junho de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de junho de 2026

Última verificação

1 de fevereiro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 20210142
  • 2022-501540-15-00 (Ctis)

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 .

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