A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
ROCKET-Orbit
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)
2 other identifiers
interventional
187
9 countries
77
Brief Summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2023
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedDecember 11, 2025
December 1, 2025
2.5 years
November 22, 2022
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Serious Adverse Events
Up to 52 Weeks
Study Arms (1)
Rocatinlimab
EXPERIMENTALRocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (77)
Phoenix Childrens Hosptial
Phoenix, Arizona, 85016, United States
Medical Advancement Centers of Arizona
Tempe, Arizona, 85283, United States
Dermatology Trial Associates
Bryant, Arkansas, 72022, United States
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, 72205, United States
University of California Irvine
Irvine, California, 92697, United States
University of California Los Angeles
Los Angeles, California, 90024, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Manlio Dermatology
Kissimmee, Florida, 34741, United States
Palm Springs Community Health Center
Miami, Florida, 33014, United States
ARA Professionals Limited Liability Corporation
Miami, Florida, 33176, United States
Deluxe Health Care LLC
Miami Lakes, Florida, 33014, United States
Bluegrass Allergy Care
Lexington, Kentucky, 40509, United States
Windsor Dermatology dba Eczema Treatment Center of New Jersey
East Windsor, New Jersey, 08520, United States
Smart Medical Research Inc
Jackson Heights, New York, 11372, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Auni Allergy
Findlay, Ohio, 45840, United States
Oregon Medical Research Center
Portland, Oregon, 97201, United States
DermDox Dermatology, LLC
Sugarloaf, Pennsylvania, 18249, United States
Driscoll Childrens Hospital
Corpus Christi, Texas, 78411, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
University of Utah MidValley Dermatology
Murray, Utah, 84107, United States
Cinme - Centro de Investigaciones Metabolicas
CABA, Buenos Aires, C1027AAP, Argentina
Fundacion Cidea
Buenos Aires, Distrito Federal, 1121, Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, Distrito Federal, 1425, Argentina
Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
Rosario, Santa Fe Province, 2000, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000, Argentina
Instituto de Diagnostico ABC
Rosario, Santa Fe Province, 2000, Argentina
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
The Skin Hospital
Darlinghurst, New South Wales, 2010, Australia
Premier Specialists
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
Monash Childrens Hospital
Clayton, Victoria, 3168, Australia
Institute for Skin Health and Immunity
Mitcham, Victoria, 3132, Australia
Universidade Federal do Parana
Curitiba, Paraná, 80060-240, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Fundacao Abc - Centro Univ Fmabc
Santo André, São Paulo, 09060-870, Brazil
Ispem-Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, 12243-280, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050, Brazil
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
São Paulo, 06454-010, Brazil
Dermatology Research Institute Incorporated
Calgary, Alberta, T2J 7E1, Canada
Stratica Dermatology
Edmonton, Alberta, T5K 1X3, Canada
Vida Clinical Research
Edmonton, Alberta, T6H 4J8, Canada
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2, Canada
Skincare Studio
St. John's, Newfoundland and Labrador, A1E 1V4, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1, Canada
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6, Canada
LEADER Research
Hamilton, Ontario, L8L 3C3, Canada
Triple A Lab
Hamilton, Ontario, L8S 1G5, Canada
JRB Research Incorporated
Ottawa, Ontario, K2C 3N2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Toronto Research Centre Inc
Toronto, Ontario, M3H 5Y8, Canada
FACET Dermatology
Toronto, Ontario, M4E 1R7, Canada
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Korea University Ansan Hospital
Ansansi, Gyeonggido, 15355, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
National Medical Center
Seoul, 04564, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Ewha Womans University Seoul Hospital
Seoul, 07804, South Korea
Bezmialem Vakif Universitesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir, 35620, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, 38030, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200, Turkey (Türkiye)
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
Velocity Clinical Research, High Wycombe
High Wycombe, HP11 2QW, United Kingdom
Alder Hey Childrens Hospital
Liverpool, L12 2AP, United Kingdom
Whipps Cross University Hospital
London, E11 1NR, United Kingdom
St Thomas Hospital
London, SE1 7EH, United Kingdom
Carn to Coast Health Centres
Redruth, TR16 4ET, United Kingdom
Related Publications (1)
Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
PMID: 40012373BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2022
First Posted
December 1, 2022
Study Start
January 30, 2023
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.