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A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Sponsor: Amgen
Summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Official title: A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
187
Start Date
2023-01-30
Completion Date
2025-07-31
Last Updated
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
Rocatinlimab
Subcutaneous (SC) injection
Locations (77)
Phoenix Childrens Hosptial
Phoenix, Arizona, United States
Medical Advancement Centers of Arizona
Tempe, Arizona, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, United States
University of California Irvine
Irvine, California, United States
University of California Los Angeles
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Manlio Dermatology
Kissimmee, Florida, United States
Palm Springs Community Health Center
Miami, Florida, United States
ARA Professionals Limited Liability Corporation
Miami, Florida, United States
Deluxe Health Care LLC
Miami Lakes, Florida, United States
Bluegrass Allergy Care
Lexington, Kentucky, United States
Windsor Dermatology dba Eczema Treatment Center of New Jersey
East Windsor, New Jersey, United States
Smart Medical Research Inc
Jackson Heights, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Auni Allergy
Findlay, Ohio, United States
Oregon Medical Research Center
Portland, Oregon, United States
DermDox Dermatology, LLC
Sugarloaf, Pennsylvania, United States
Driscoll Childrens Hospital
Corpus Christi, Texas, United States
Modern Research Associates
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
University of Utah MidValley Dermatology
Murray, Utah, United States
Cinme - Centro de Investigaciones Metabolicas
CABA, Buenos Aires, Argentina
Fundacion Cidea
Buenos Aires, Distrito Federal, Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, Distrito Federal, Argentina
Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
Rosario, Santa Fe Province, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Instituto de Diagnostico ABC
Rosario, Santa Fe Province, Argentina
Woden Dermatology
Phillip, Australian Capital Territory, Australia
The Skin Hospital
Darlinghurst, New South Wales, Australia
Premier Specialists
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Monash Childrens Hospital
Clayton, Victoria, Australia
Institute for Skin Health and Immunity
Mitcham, Victoria, Australia
Universidade Federal do Parana
Curitiba, Paraná, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Abc - Centro Univ Fmabc
Santo André, São Paulo, Brazil
Ispem-Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, Brazil
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
São Paulo, Brazil
Dermatology Research Institute Incorporated
Calgary, Alberta, Canada
Stratica Dermatology
Edmonton, Alberta, Canada
Vida Clinical Research
Edmonton, Alberta, Canada
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada
Skincare Studio
St. John's, Newfoundland and Labrador, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
Halton Pediatric Allergy
Burlington, Ontario, Canada
LEADER Research
Hamilton, Ontario, Canada
Triple A Lab
Hamilton, Ontario, Canada
JRB Research Incorporated
Ottawa, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Toronto Research Centre Inc
Toronto, Ontario, Canada
FACET Dermatology
Toronto, Ontario, Canada
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Korea University Ansan Hospital
Ansansi, Gyeonggido, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
National Medical Center
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Bezmialem Vakif Universitesi Hastanesi
Istanbul, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey (Türkiye)
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye)
Bristol Royal Hospital for Children
Bristol, United Kingdom
Velocity Clinical Research, High Wycombe
High Wycombe, United Kingdom
Alder Hey Childrens Hospital
Liverpool, United Kingdom
Whipps Cross University Hospital
London, United Kingdom
St Thomas Hospital
London, United Kingdom
Carn to Coast Health Centres
Redruth, United Kingdom