A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
June 29, 2026 updated by: Amgen
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
187
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentina, 1121
- Fundacion CIDEA
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Buenos Aires, Distrito Federal, Argentina, 1425
- Instituto de Neumonología Y Dermatología
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
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Rosario, Santa Fe Province, Argentina, 2000
- Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentina, 2000
- Instituto de Diagnostico ABC
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Australian Capital Territory
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Phillip, Australian Capital Territory, Australia, 2606
- Woden Dermatology
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- The Skin Hospital
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Kogarah, New South Wales, Australia, 2217
- Premier Specialists
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Queensland
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Benowa, Queensland, Australia, 4217
- The Skin Centre
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Woolloongabba, Queensland, Australia, 4102
- Veracity Clinical Research
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Childrens Hospital
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Mitcham, Victoria, Australia, 3132
- Institute for Skin Health and Immunity
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São Paulo, Brazil, 06454-010
- Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
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Paraná
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Curitiba, Paraná, Brazil, 80060-240
- Universidade Federal do Parana
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
- Hospital Ernesto Dornelles
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São Paulo
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Santo André, São Paulo, Brazil, 09060-870
- Fundacao Abc - Centro Univ Fmabc
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São José dos Campos, São Paulo, Brazil, 12243-280
- Ispem-Instituto São José dos Campos em Pesquisas Médicas
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São Paulo, São Paulo, Brazil, 01308-050
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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Alberta
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Calgary, Alberta, Canada, T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton, Alberta, Canada, T5K 1X3
- Stratica Dermatology
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Edmonton, Alberta, Canada, T6H 4J8
- Vida Clinical Research
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
- Winnipeg Clinic Dermatology Research
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1E 1V4
- Skincare Studio
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Centre
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Burlington, Ontario, Canada, L7L 6W6
- Halton Pediatric Allergy
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Hamilton, Ontario, Canada, L8L 3C3
- Leader Research
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Hamilton, Ontario, Canada, L8S 1G5
- Triple A Lab
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Ottawa, Ontario, Canada, K2C 3N2
- JRB Research Incorporated
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Peterborough, Ontario, Canada, K9J 5K2
- Skin Centre for Dermatology
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Toronto, Ontario, Canada, M3H 5Y8
- Toronto Research Centre Inc
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Toronto, Ontario, Canada, M4E 1R7
- FACET Dermatology
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Hong Kong, Hong Kong
- University of Hong Kong, Queen Mary Hospital
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Ansansi, Gyeonggido, South Korea, 15355
- Korea University Ansan Hospital
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Seoul, South Korea, 03080
- Seoul National University Hospital
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Seoul, South Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, South Korea, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, South Korea, 06973
- Chung-Ang University Hospital
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Seoul, South Korea, 07441
- Hallym University Kangnam Sacred Heart Hospital
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Seoul, South Korea, 04564
- National Medical Center
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Seoul, South Korea, 07804
- Ewha Womans University Seoul Hospital
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Istanbul, Turkey (Türkiye), 34098
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
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Istanbul, Turkey (Türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
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Izmir, Turkey (Türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
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Kayseri, Turkey (Türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
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Samsun, Turkey (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Bristol, United Kingdom, BS2 8BJ
- Bristol Royal Hospital for Children
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High Wycombe, United Kingdom, HP11 2QW
- Velocity Clinical Research, High Wycombe
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Liverpool, United Kingdom, L12 2AP
- Alder Hey Childrens Hospital
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London, United Kingdom, E11 1NR
- Whipps Cross University Hospital
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London, United Kingdom, SE1 7EH
- St Thomas Hospital
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Redruth, United Kingdom, TR16 4ET
- Carn to Coast Health Centres
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Childrens Hosptial
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Tempe, Arizona, United States, 85283
- Medical Advancement Centers of Arizona
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Arkansas
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Bryant, Arkansas, United States, 72022
- Dermatology Trial Associates
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Little Rock, Arkansas, United States, 72205
- Little Rock Allergy and Asthma Clinical Research Center
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California
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Irvine, California, United States, 92697
- University of California Irvine
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Los Angeles, California, United States, 90045
- Dermatology Research Associates
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Los Angeles, California, United States, 90024
- University of California Los Angeles
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Florida
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Kissimmee, Florida, United States, 34741
- Manlio Dermatology
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Miami, Florida, United States, 33014
- Palm Springs Community Health Center
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Miami, Florida, United States, 33176
- ara Professionals Limited Liability Corporation
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Miami Lakes, Florida, United States, 33014
- Deluxe Health Care LLC
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Kentucky
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Lexington, Kentucky, United States, 40509
- Bluegrass Allergy Care
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New Jersey
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East Windsor, New Jersey, United States, 08520
- Windsor Dermatology dba Eczema Treatment Center of New Jersey
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New York
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Jackson Heights, New York, United States, 11372
- Smart Medical Research Inc
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Ohio
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Findlay, Ohio, United States, 45840
- Auni Allergy
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Oregon
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Portland, Oregon, United States, 97201
- Oregon Medical Research Center
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Pennsylvania
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Sugarloaf, Pennsylvania, United States, 18249
- DermDox Dermatology, LLC
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Texas
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Corpus Christi, Texas, United States, 78411
- Driscoll Childrens Hospital
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Dallas, Texas, United States, 75231
- Modern Research Associates
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Houston, Texas, United States, 77004
- Center for Clinical Studies
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Utah
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Murray, Utah, United States, 84107
- University of Utah MidValley Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Rocatinlimab
Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.
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Subcutaneous (SC) injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks
|
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment. A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention. |
From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline and Presence of Barely Perceptible Erythema or No Erythema at Week 24
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2023
Primary Completion (Actual)
July 31, 2025
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
November 22, 2022
First Submitted That Met QC Criteria
November 22, 2022
First Posted (Actual)
December 1, 2022
Study Record Updates
Last Update Posted (Actual)
July 24, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210263
- 2022-001548-99 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.