Clinical Trial Details for

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT ID: NCT05633355

Last Updated: April 25, 2024

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)


The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

The Study at a Glance


Phase: Phase 3

Gender: ALL

Age: 12 Years - 17 Years

Condition: Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: Amgen


Ages Eligible for Study: 12 Years to 17 Years

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Inclusion Criteria: * Age ≥ 12 to < 18 years at day 1. * Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent * Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) * Eczema Area and Severity Index (EASI) score ≥ 12 * vIGA-AD score ≥ 3 * ≥ 10% BSA of AD involvement at day 1 pre-enrollment Exclusion Criteria: * Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 * Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: * Systemic corticosteroids * Systemic immunosuppressants * Phototherapy * Oral or topical janus kinase inhibitors * Treatment with any of the following agents within 1 week before day 1 pre-enrollment: * Topical PDE4 inhibitors * Other topical immunosuppressive agents (not including TCS/TCI) * Combination topical agents containing a high- or super-high potency corticosteroid

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: MD

Please refer to this study by its identifier: NCT05633355

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

Deluxe Health Care LLC

Miami Lakes, Florida, United States

Palm Springs Community Health Center

Miami, Florida, United States

ARA Professionals LLC

Miami, 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

Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina

Instituto de Neumonologia y Dermatologia

Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina

Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario

Rosario, Santa Fe, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe, Argentina

Instituto de Diagnostico Abc American British Cowdray

Rosario, Santa Fe, 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 Andre, São Paulo, Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

Sao Paulo, São Paulo, Brazil

Ispem-Instituto São José dos Campos em Pesquisas Médicas

São José dos Campos, 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, Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of

National Medical Center

Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong

Seoul, Korea, Republic of

The Catholic University of Korea Seoul St Marys Hospital

Seoul, Korea, Republic of

Chung-Ang University Hospital

Seoul, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital

Seoul, Korea, Republic of

Ewha Womans University Seoul Hospital

Seoul, Korea, Republic of

Bezmialem Vakif Universitesi Hastanesi

Istanbul, Turkey

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey

Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi

Izmir, Turkey

Erciyes Universitesi Tip Fakultesi Hastanesi

Kayseri, Turkey

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, Turkey

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

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