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Um estudo de Fase 3, controlado por placebo, duplo-cego avaliando a monoterapia de Rocatinlimabe (AMG 451) em dermatite atópica (DA) moderada a grave (ROCKET-Horizon) (ROCKET-Horizon)

2 de junho de 2026 atualizado por: Amgen

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

Os objetivos co-primários do estudo são:

Avalie a eficácia de rocatinlimabe em comparação com o placebo na Semana 24, avaliada usando a Avaliação Global do Investigador Validado para Dermatite Atópica (vIGA-AD).
Avalie a eficácia de rocatinlimabe em comparação com o placebo na Semana 24, avaliada usando o Índice de Área e Gravidade do Eczema (EASI).

Visão geral do estudo

Status

Concluído

Condições

Dermatite atópica

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

726

Estágio

Fase 3

Contactos e Locais

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

Locais de estudo

Alemanha
- - Bad Bentheim, Alemanha, 48455
    - Fachklinik Bad Bentheim
  - Berlin, Alemanha, 10247
    - Hautzentrum Friedrichshain - Dermatologie
  - Berlin, Alemanha, 13672
    - Clinical Research Services Berlin GmbH
  - Halle, Alemanha, 06120
    - Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
  - Hamburg, Alemanha, 20354
    - Dermatologikum Hamburg
  - Kiel, Alemanha, 24105
    - Universitaetsklinikum Schleswig-Holstein
  - Leipzig, Alemanha, 04103
    - Velocity Clinical Research
  - Münster, Alemanha, 48149
    - Universitaetsklinikum Muenster
  - Osnabrück, Alemanha, 49074
    - KliFOs Klinische Forschung Osnabrueck
  - Remscheid, Alemanha, 42897
    - Hautarztpraxis Mortazawi
  - Wuppertal, Alemanha, 42283
    - Helios Klinikum Wuppertal
Austrália
- New South Wales
  - Darlinghurst, New South Wales, Austrália, 2010
    - St George Dermatology and Skin Cancer Centre
  - Kogarah, New South Wales, Austrália, 2217
    - Premier Specialists
- Victoria
  - Box Hill, Victoria, Austrália, 3128
    - Box Hill Hospital
  - Carlton, Victoria, Austrália, 3053
    - Skin Health Institute
  - East Melbourne, Victoria, Austrália, 3002
    - Sinclair Dermatology
  - Melbourne, Victoria, Austrália, 3004
    - The Alfred Hospital
  - Parkville, Victoria, Austrália, 3050
    - The Royal Melbourne Hospital
Brasil
- Paraná
  - Curitiba, Paraná, Brasil, 80030-110
    - CETI - Centro de Estudo em Terapias Inovadoras
- São Paulo
  - São Bernardo do Campo, São Paulo, Brasil, 09715-090
    - Centro Multidisciplinar de Estudos Clínicos - CEMEC
  - São José dos Campos, São Paulo, Brasil, 12243-280
    - ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
Bélgica
- - Brussels, Bélgica, 1070
    - Hopital Erasme
  - Herstal, Bélgica, 4040
    - Clinique Andre Renard
  - Maldegem, Bélgica, 9990
    - Dermatologie Maldegem
Canadá
- Alberta
  - Calgary, Alberta, Canadá, T3E 0B2
    - Beacon Dermatology
- British Columbia
  - Surrey, British Columbia, Canadá, V3R 6A7
    - Doctor Chih-Ho Hong Medical Incorporated
- Ontario
  - Etobicoke, Ontario, Canadá, M8X 1Y9
    - Kingsway Clinical Research
  - Markham, Ontario, Canadá, L3P 1X3
    - Lynderm Research Inc
  - Oakville, Ontario, Canadá, L6J 7W5
    - The Centre for Clinical Trials Inc
  - Peterborough, Ontario, Canadá, K9J 5K2
    - SKiN Centre for Dermatology
  - Richmond Hill, Ontario, Canadá, L4B 1A5
    - The Centre for Dermatology
  - Toronto, Ontario, Canadá, M4W 2N4
    - Research Toronto
  - Windsor, Ontario, Canadá, N8T 1E6
    - XLR8 Medical Research, Incorporated
- Quebec
  - Québec, Quebec, Canadá, G1V 4X7
    - Centre de Recherche Dermatologique du Quebec metropolitain
  - Sherbrooke, Quebec, Canadá, J1G 1X9
    - Clinique Dermatologique de Sherbrooke
Coréia do Sul
- - Ansansi, Gyeonggido, Coréia do Sul, 15355
    - Korea University Ansan Hospital
  - Bucheon-si, Gyeonggi-do, Coréia do Sul, 14584
    - Soon Chun Hyang University Bucheon Hospital
  - Busan, Coréia do Sul, 49241
    - Pusan National University Hospital
  - Daegu, Coréia do Sul, 41944
    - Kyungpook National University Hospital
  - Gwangju, Coréia do Sul, 61453
    - Chosun University Hospital
  - Incheon, Coréia do Sul, 22332
    - Inha University Hospital
  - Incheon, Coréia do Sul, 21431
    - The Catholic University of Korea Incheon St Marys Hospital
  - Seongnam-si, Gyeonggi-do, Coréia do Sul, 13620
    - Seoul National University Bundang Hospital
  - Seoul, Coréia do Sul, 03080
    - Seoul National University Hospital
  - Seoul, Coréia do Sul, 05505
    - Asan Medical Center
  - Seoul, Coréia do Sul, 03722
    - Severance Hospital, Yonsei University Health System
  - Seoul, Coréia do Sul, 05278
    - Kyung Hee University Hospital at Gangdong
  - Seoul, Coréia do Sul, 02841
    - Korea University Anam Hospital
  - Seoul, Coréia do Sul, 05030
    - Konkuk University Medical Center
  - Seoul, Coréia do Sul, 06973
    - Chung-Ang University Hospital
  - Seoul, Coréia do Sul, 07441
    - Hallym University Kangnam Sacred Heart Hospital
  - Seoul, Coréia do Sul, 04564
    - National Medical Center
  - Seoul, Coréia do Sul, 07804
    - Ewha Womans University Seoul Hospital
  - Seoul, Coréia do Sul, 06591
    - The Catholic Univ of Korea Seoul St Marys Hospital
  - Suwon-si, Gyeonggi-do, Coréia do Sul, 16499
    - Ajou University Hospital
Dinamarca
- - Hellerup, Dinamarca, 2900
    - Gentofte Hospital
  - Odense, Dinamarca, 5000
    - Odense University Hospital
Espanha
- - Madrid, Espanha, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Espanha, 28046
    - Hospital Universitario La Paz
  - Majadahonda, Espanha, 28222
    - Hospital Universitario Puerta de Hierro Majadahonda
- Andalusia
  - Seville, Andalusia, Espanha, 41009
    - Hospital Universitario Virgen Macarena
- Navarre
  - Pamplona, Navarre, Espanha, 31008
    - Clinica Universidad de Navarra
- Valencia
  - Alicante, Valencia, Espanha, 03010
    - Hospital General Universitario de Alicante
  - Manises, Valencia, Espanha, 46940
    - Hospital de Manises
  - Valencia, Valencia, Espanha, 46015
    - Hospital Arnau de Vilanova de Valencia
Estados Unidos
- Arizona
  - Litchfield Park, Arizona, Estados Unidos, 85340
    - Research Solutions of Arizona, PC
  - Scottsdale, Arizona, Estados Unidos, 85260
    - Center for Dermatology and Plastic Surgery
- Arkansas
  - Fayetteville, Arkansas, Estados Unidos, 72703
    - Clinical Trials Institute of Northwest Arkansas
  - Hot Springs, Arkansas, Estados Unidos, 71913
    - Burke Pharmaceutical Research
- California
  - Chula Vista, California, Estados Unidos, 91911
    - Velocity Clinical Research Chula Vista
  - Dublin, California, Estados Unidos, 94568
    - West Coast Research LLC
  - Encinitas, California, Estados Unidos, 92024
    - California Dermatology and Clinical Research Institute
  - Fremont, California, Estados Unidos, 94538
    - Center for Dermatology Clinical Research Inc
  - La Mesa, California, Estados Unidos, 91942
    - Velocity Clinical Research - San Diego
  - North Hollywood, California, Estados Unidos, 91606
    - Velocity Clinical Research - North Hollywood
  - Palmdale, California, Estados Unidos, 93551
    - Cura Clinical Research
  - San Francisco, California, Estados Unidos, 94115
    - University of California at San Francisco, Dermatology Clinic at Mount Zion
  - Santa Monica, California, Estados Unidos, 90404
    - Clinical Science Institute
- Colorado
  - Castle Rock, Colorado, Estados Unidos, 80109
    - Clarity Dermatology
  - Denver, Colorado, Estados Unidos, 80209
    - Velocity Clinical Research - Denver
- District of Columbia
  - Washington D.C., District of Columbia, Estados Unidos, 20016
    - Foxhall Research Center
- Florida
  - Cape Coral, Florida, Estados Unidos, 33991
    - Renaissance Research and Medical Group
  - Coral Gables, Florida, Estados Unidos, 33134
    - Driven Research LLC
  - Doral, Florida, Estados Unidos, 33172
    - Saint Jude Clinical Research
  - Hialeah, Florida, Estados Unidos, 33012
    - Direct Helpers Research Center
  - Margate, Florida, Estados Unidos, 33063
    - Glick Skin Institute
  - Miami, Florida, Estados Unidos, 33176
    - Miami Dade Medical Research Institute, LLC
  - Palmetto Bay, Florida, Estados Unidos, 33157
    - Innovation Medical Research Center Inc
  - Tampa, Florida, Estados Unidos, 33612
    - University of South Florida Health Morsani Center for Advanced Healthcare
- Georgia
  - Sandy Springs, Georgia, Estados Unidos, 30328
    - Advanced Medical Research Pc
- Illinois
  - Normal, Illinois, Estados Unidos, 61761
    - Sneeze, Wheeze, and Itch Associates, LLC
- Indiana
  - South Bend, Indiana, Estados Unidos, 46617
    - The South Bend Clinic LLP
  - West Lafayette, Indiana, Estados Unidos, 47906
    - Options Research Group LLC
- Kansas
  - Overland Park, Kansas, Estados Unidos, 66223
    - Dermatology and Skin Cancer Center of Overland Park
- Kentucky
  - Louisville, Kentucky, Estados Unidos, 40241
    - DS Research
  - Murray, Kentucky, Estados Unidos, 42071
    - Kentucky Advanced Medical Research LLC
- Massachusetts
  - Brighton, Massachusetts, Estados Unidos, 02135
    - MetroBoston Clinical Partners
- Michigan
  - Farmington Hills, Michigan, Estados Unidos, 48334
    - Wendy Sadoff MD Dermatology PC
  - Troy, Michigan, Estados Unidos, 48084
    - Somerset Skin Centre
  - Troy, Michigan, Estados Unidos, 48084
    - Revival Research Institute LLC
- Nebraska
  - Omaha, Nebraska, Estados Unidos, 68144
    - Advanced Dermatology of the Midlands
- Nevada
  - Las Vegas, Nevada, Estados Unidos, 89117
    - James Del Rosso Dermatology Research
  - Reno, Nevada, Estados Unidos, 89509
    - Skin Cancer and Dermatology Institute
- New Hampshire
  - Lebanon, New Hampshire, Estados Unidos, 03766
    - Dartmouth-Hitchcock Medical Center
- New Jersey
  - Riverdale, New Jersey, Estados Unidos, 07457
    - Weiss Medical
- New York
  - Horseheads, New York, Estados Unidos, 14845
    - Corning Center for Clinical Research
  - Kew Gardens, New York, Estados Unidos, 11415
    - Forest Hills Dermatology Group
  - Monroe, New York, Estados Unidos, 10950
    - Crystal Run Healthcare
  - New York, New York, Estados Unidos, 10029
    - Icahn School of Medicine at Mount Sinai
  - New York, New York, Estados Unidos, 10022
    - Ace Clinical Trials
  - New York, New York, Estados Unidos, 10128
    - OptiSkin Medical
  - The Bronx, New York, Estados Unidos, 10467
    - Montefiore Medical Center
- North Carolina
  - Durham, North Carolina, Estados Unidos, 27713
    - Duke South Durham
- Ohio
  - Cincinnati, Ohio, Estados Unidos, 45219
    - University of Cincinnati
  - Cincinnati, Ohio, Estados Unidos, 45236
    - Bernstein Clinical Research Center LLC
  - Gahanna, Ohio, Estados Unidos, 43230
    - The Ohio State University Dermatology East
- Oregon
  - Grants Pass, Oregon, Estados Unidos, 97527
    - Velocity Clinical Research - Grants Pass
  - Portland, Oregon, Estados Unidos, 97223
    - Oregon Medical Research Center
- Rhode Island
  - Warwick, Rhode Island, Estados Unidos, 02886
    - Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
- Texas
  - Bellaire, Texas, Estados Unidos, 77401
    - Bellaire Dermatology Associates
  - Cedar Park, Texas, Estados Unidos, 78613
    - US Dermatology Partners Cedar Park
  - Dallas, Texas, Estados Unidos, 75225
    - Alina Clinical Trials, LLC
  - Dallas, Texas, Estados Unidos, 75230
    - Zenos Clinical Research, LLC
  - Houston, Texas, Estados Unidos, 77030
    - The University of Texas Health Science Center at Houston
  - Houston, Texas, Estados Unidos, 77037
    - MedCare Pharma - Houston
  - Lampasas, Texas, Estados Unidos, 76550
    - FMCScience LLC
  - Lewisville, Texas, Estados Unidos, 75057
    - Epic Clinical Research Incorporated
  - Missouri City, Texas, Estados Unidos, 77459
    - Sienna Dermatology Research
  - San Antonio, Texas, Estados Unidos, 78218
    - Texas Dermatology and Laser Specialists
  - San Antonio, Texas, Estados Unidos, 78229
    - Dermatology Clinical Research Center of San Antonio
  - San Antonio, Texas, Estados Unidos, 78229
    - Andante Research
- Utah
  - Murray, Utah, Estados Unidos, 84107
    - University of Utah Midvalley Dermatology
- Virginia
  - Norfolk, Virginia, Estados Unidos, 23507
    - Eastern Virginia Medical School
- Washington
  - Spokane, Washington, Estados Unidos, 99202
    - MultiCare Institute for Research and Innovation
Estônia
- - Tallinn, Estônia, 13419
    - North Estonia Medical Centre
  - Tartu, Estônia, 50106
    - Clinical Research Centre
Finlândia
- - Helsinki, Finlândia, 00180
    - CRST Helsinki
  - Helsinki, Finlândia, 00180
    - CRST Turku
  - Oulu, Finlândia, 90029
    - Oulun Yliopistollinen sairaala (OYS)
  - Tampere, Finlândia, 33100
    - Terveystalo Tampere
Japão
- Chiba
  - Matsudo-shi, Chiba, Japão, 271-0092
    - Miyata Dermatology Clinic
  - Narita-shi, Chiba, Japão, 286-8520
    - International University of Health and Welfare Narita Hospital
- Hyōgo
  - Kobe, Hyōgo, Japão, 650-0017
    - Kobe University Hospital
- Kanagawa
  - Kawasaki-shi, Kanagawa, Japão, 216-8511
    - St Marianna University Hospital
  - Sagamihara-shi, Kanagawa, Japão, 252-0392
    - National Hospital Organization Sagamihara National Hospital
  - Yokohama, Kanagawa, Japão, 224-8503
    - Showa University Northern Yokohama Hospital
- Nagasaki
  - Nagasaki, Nagasaki, Japão, 852-8501
    - Nagasaki University Hospital
- Osaka
  - Habikino-shi, Osaka, Japão, 583-8588
    - Osaka Habikino Medical Center
  - Sakai-shi, Osaka, Japão, 593-8324
    - Dermatology and Ophthalmology Kume Clinic
- Shizuoka
  - Hamamatsu, Shizuoka, Japão, 431-3192
    - Hamamatsu University Hospital
- Tokyo
  - Minato-ku, Tokyo, Japão, 108-0014
    - Mita Dermatology Clinic
  - Shinagawa-ku, Tokyo, Japão, 142-8666
    - Showa University Hospital
  - Shinjuku-ku, Tokyo, Japão, 161-8521
    - Seibo International Catholic Hospital
  - Toshima-ku, Tokyo, Japão, 170-0002
    - Sugamo Kobayashi Derma Clinic
- Toyama
  - Takaoka-shi, Toyama, Japão, 933-0871
    - Shirasaki dermatology clinic
México
- - Chihuahua City, México, 31203
    - SCIENTIA Investigacion Clinica SC
  - Cuautitlán Izcalli, México, 54750
    - Phylasis Clínicas Research S. De R. L. De C. V.
- Michoacán
  - Morelia, Michoacán, México, 58249
    - Clinica de Enfermedades Cronicas y de Procedimientos Especiales
Polônia
- - Bialystok, Polônia, 15-879
    - ClinicMed Daniluk Nowak Spolka Komandytowa
  - Chorzów, Polônia, 41-500
    - Dermapolis Medical Dermatology Center dr n med Edyta Gebska
  - Gdansk, Polônia, 80-214
    - Uniwersyteckie Centrum Kliniczne
  - Krakow, Polônia, 31-530
    - Centermed krakow sp zoo
  - Lodz, Polônia, 90-349
    - AppleTreeClinics Network Spzoo
  - Lodz, Polônia, 90-338
    - Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  - Lodz, Polônia, 91-495
    - Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
  - Lublin, Polônia, 20-078
    - Clinical Best Solutions Sp zoo Spolka komandytowa
  - Poznan, Polônia, 61-731
    - Clinical Research Center Spzoo Medic-R Spolka Komandytowa
  - Warsaw, Polônia, 02-625
    - Evimed sp zoo centrum medyczne evimed
Portugal
- - Almada, Portugal, 2801-951
    - Hospital Garcia de Orta, EPE
  - Coimbra, Portugal, 3000-075
    - Centro Hospitalar e Universitário de Coimbra, EPE
  - Lisbon, Portugal, 1998-018
    - Hospital CUF Descobertas
  - Porto, Portugal, 4099-001
    - Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
  - Porto, Portugal, 4200-319
    - Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
Reino Unido
- - Corby, Reino Unido, NN17 2UR
    - Lakeside Healthcare
  - London, Reino Unido, SE1 9RT
    - Guys Hospital
  - Southampton, Reino Unido, SO16 6YD
    - Southampton General Hospital
Romênia
- - Bucharest, Romênia, 020125
    - Spitalul Clinic Colentina
Suécia
- - Stockholm, Suécia, 171 76
    - Karolinska Universitetssjukhuset Solna
Tcheca
- - Kutná Hora, Tcheca, 284 01
    - Kozni ambulance Kutna Hora sro
  - Nový Jičín, Tcheca, 741 01
    - Nemocnice Novy Jicin as
  - Pardubice, Tcheca, 530 02
    - CCR Czech as
  - Pilsen, Tcheca, 305 99
    - Fakultni Nemocnice Plzen
  - Prague, Tcheca, 130 00
    - CCR Prague sro
  - Prague, Tcheca, 120 00
    - Dermamedest sro
  - Prague, Tcheca, 106 00
    - Kozni ambulance Fialova sro
  - Prague, Tcheca, 150 00
    - Praglandia sro
  - Svitavy, Tcheca, 568 02
    - Dermatologicka ambulance MUDr Petr Trestik
Turquia (Türkiye)
- - Ankara, Turquia (Türkiye), 06230
    - Hacettepe Universitesi Tip Fakultesi Hastanesi
  - Gaziantep, Turquia (Türkiye), 27310
    - Gaziantep Universitesi Tip Fakultesi Hastanesi
  - Istanbul, Turquia (Türkiye), 34093
    - Bezmialem Vakif Universitesi Hastanesi
  - Izmir, Turquia (Türkiye), 35620
    - Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
  - Kayseri, Turquia (Türkiye), 38030
    - Erciyes Universitesi Tip Fakultesi Hastanesi
  - Kocaeli, Turquia (Türkiye), 41380
    - Kocaeli Universitesi Tip Fakultesi Hastanesi
  - Sakarya, Turquia (Türkiye), 54050
    - Sakarya Egitim ve Arastirma Hastanesi
África do Sul
- - Durban, África do Sul, 3630
    - Hiway Medical Centre
- Gauteng
  - Centurion, Gauteng, África do Sul, 0157
    - Ryexo Clinical Research
  - Johannesburg, Gauteng, África do Sul, 2057
    - About Allergy

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:
- Corticosteroides 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
- 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

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: Rocatinlimabe Rocatinlimabe Dose 1 a cada 4 semanas (Q4W) por 24 semanas com uma dose de ataque na Semana 2.	Medicamento: Rocatinlimabe Rocatinlimab será administrado por injeção subcutânea (SC). Outros nomes: AMG 451 KHK 4083
Comparador de Placebo: Placebo Placebo Q4W por 24 semanas com uma dose de ataque na semana 2.	Outro: Placebo O placebo correspondente será administrado por meio de uma injeção SC.

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 vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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 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 ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4 Prazo: Baseline and Week 24	AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.	Baseline and Week 24
Number of Participants Who Achieved 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
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 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 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 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
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of 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 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
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
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24 Prazo: Baseline and Week 24	Weekly 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
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

Colaboradores e Investigadores

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

Patrocinador

Amgen

Investigadores

Diretor de estudo: MD, Amgen

Publicações e links úteis

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

Publicações Gerais

Links úteis

AmgenTrials clinical trials website

Datas de registro do estudo

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

Datas Principais do Estudo

Início do estudo (Real)

14 de dezembro de 2022

Conclusão Primária (Real)

5 de junho de 2024

Conclusão do estudo (Real)

27 de agosto de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

7 de dezembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de dezembro de 2022

Primeira postagem (Real)

15 de dezembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

20210143
2022-501538-44 (Outro identificador: EU CT Number)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

PROTOCOLO DE ESTUDO
SEIVA
CIF
CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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

Um estudo de Fase 3, controlado por placebo, duplo-cego avaliando a monoterapia de Rocatinlimabe (AMG 451) em dermatite atópica (DA) moderada a grave (ROCKET-Horizon) (ROCKET-Horizon)

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

Visão geral do estudo

Status

Condições

Intervenção / Tratamento

Tipo de estudo

Inscrição (Real)

Estágio

Contactos e Locais

Locais de estudo

Critérios de participação

Critérios de elegibilidade

Idades elegíveis para estudo

Aceita Voluntários Saudáveis

Descrição

Plano de estudo

Como o estudo é projetado?

Detalhes do projeto

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço

Intervenção / Tratamento

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado

Descrição da medida

Prazo

Medidas de resultados secundários

Medida de resultado

Descrição da medida

Prazo

Colaboradores e Investigadores

Patrocinador

Investigadores

Publicações e links úteis

Publicações Gerais

Links úteis

Datas de registro do estudo

Datas Principais do Estudo

Início do estudo (Real)

Conclusão Primária (Real)

Conclusão do estudo (Real)

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez que atendeu aos critérios de CQ

Primeira postagem (Real)

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última verificação

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Descrição do plano IPD

Prazo de Compartilhamento de IPD

Critérios de acesso de compartilhamento IPD

Tipo de informação de suporte de compartilhamento de IPD

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Estuda um produto de dispositivo regulamentado pela FDA dos EUA