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NCT05633355 Clinical Trial

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

Atopic Dermatitis Clinical Trial

— ROCKET-Orbit  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05633355
Other study ID # 20210263
Secondary ID 2022-001548-99
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 30, 2023
Est. completion date July 28, 2025

Study information
Verified date May 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 187
Est. completion date July 28, 2025
Est. primary completion date May 7, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rocatinlimab
Subcutaneous (SC) injection

Locations
Country Name City State
Argentina 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 Rosario Santa Fe
Australia The Skin Centre Benowa Queensland
Australia Monash Childrens Hospital Clayton Victoria
Australia The Skin Hospital Darlinghurst New South Wales
Australia Premier Specialists Kogarah New South Wales
Australia Liverpool Hospital Liverpool New South Wales
Australia Institute for Skin Health and Immunity Mitcham Victoria
Australia Woden Dermatology Phillip Australian Capital Territory
Australia Royal North Shore Hospital St Leonards New South Wales
Australia Veracity Clinical Research Woolloongabba Queensland
Brazil 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 Ispem-Instituto São José dos Campos em Pesquisas Médicas São José dos Campos São Paulo
Brazil Sociedade Beneficente de Senhoras Hospital Sirio Libanes Sao Paulo São Paulo
Brazil Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia São Paulo
Canada SimcoDerm Medical and Surgical Dermatology Centre Barrie Ontario
Canada Halton Pediatric Allergy Burlington Ontario
Canada Dermatology Research Institute Incorporated Calgary Alberta
Canada Stratica Dermatology Edmonton Alberta
Canada Vida Clinical Research Edmonton Alberta
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 Skincare Studio St. John's Newfoundland and Labrador
Canada FACET Dermatology Toronto Ontario
Canada Toronto Research Centre Inc Toronto Ontario
Canada Winnipeg Clinic Dermatology Research Winnipeg Manitoba
Hong Kong University of Hong Kong, Queen Mary Hospital Hong Kong
Korea, Republic of Korea University Ansan Hospital Ansansi, Gyeonggido
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Ewha Womans University Seoul Hospital Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of National Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St Marys Hospital Seoul
Turkey 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
United Kingdom Bristol Royal Hospital for Children Bristol
United Kingdom Velocity Clinical Research, High Wycombe High Wycombe
United Kingdom Alder Hey Childrens Hospital Liverpool
United Kingdom St Thomas Hospital London
United Kingdom Whipps Cross University Hospital London
United Kingdom Carn to Coast Health Centres Redruth
United States Dermatology Trial Associates Bryant Arkansas
United States Driscoll Childrens Hospital Corpus Christi Texas
United States Modern Research Associates Dallas Texas
United States Windsor Dermatology dba Eczema Treatment Center of New Jersey East Windsor New Jersey
United States Auni Allergy Findlay Ohio
United States Center for Clinical Studies Houston Texas
United States University of California Irvine Irvine California
United States Smart Medical Research Inc Jackson Heights New York
United States Manlio Dermatology Kissimmee Florida
United States Bluegrass Allergy Care Lexington Kentucky
United States Little Rock Allergy and Asthma Clinical Research Center Little Rock Arkansas
United States Dermatology Research Associates Los Angeles California
United States University of California Los Angeles Los Angeles California
United States ARA Professionals Limited Liability Corporation Miami Florida
United States Palm Springs Community Health Center Miami Florida
United States Deluxe Health Care LLC Miami Lakes Florida
United States University of Utah MidValley Dermatology Murray Utah
United States Icahn School of Medicine at Mount Sinai New York New York
United States Phoenix Childrens Hosptial Phoenix Arizona
United States Oregon Medical Research Center Portland Oregon
United States DermDox Dermatology, LLC Sugarloaf Pennsylvania
United States Medical Advancement Centers of Arizona Tempe Arizona

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Hong Kong,  Korea, Republic of,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-emergent Serious Adverse Events Up to 52 Weeks
See also
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Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
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Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2

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