Phase 3 Study Assessing Rocatinlimab in Adolescents With Atopic Dermatitis (ROCKET-Orbit)
Research type
Research Study
Full 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)
IRAS ID
1006787
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2022-001548-99
Clinicaltrials.gov Identifier
Research summary
Research Summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 20% of adolescents and is a condition that causes dry scaly skin and itching. \n\nRocatinlimab looks to reduce inflammation. Improvements in severity of AD were observed in previous studies of rocatinlimab compared to an inactive ingredient (placebo). \n\nThis study will be conducted in adolescent patients who are aged 12 or older but younger than 18 years old with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications (applied externally on the skin). \n\nThe aim of the study is to confirm the safety and how someone feels while taking rocatinlimab. \n\n170 patients will be enrolled globally; patients will receive a set dose of rocatinlimab by injection under the skin every 4 weeks for 52 weeks with an additional dose at week 2. After 6 weeks, if patient’s AD returns or gets worse, they may, in addition, receive rescue medication and/or therapy. \n\nSafety of rocatinlimab will be measured by the number and nature of any serious adverse events that may be experienced by participants globally. Effectiveness will be measured by investigators using the following data collection tools: Eczema Area and Severity Index (EASI) and Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-ADTM). EASI score is used to measure the extent (area) and severity of AD. vIGA-ADTM is a standardised severity assessment for use in clinical trial and registries for AD. Participants will also complete questionnaires at various time point during the study. \n\nOnce they provide consent, patients will undergo screening procedures to assess their eligibility for the study. 12 months after the study has finished globally, a summary of the trial results will be made available to the public.
Summary of Results
"Study Name
Title of the Study: 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).
Brief Title: A Phase 3 study assessing safety and efficacy of rocatinlimab in adolescents with moderate-to-severe AD.
Protocol Number: 20210263
EU Clinical Trial Number: 2022-001548-99
Other Identifiers: NCT05633355
Date of This Summary: 30 January 2026
This summary shows the main results from one clinical study. The results are only for
this study. Other studies may find different results. Researchers and health authorities
look at the results of many studies to decide which medicines work best and are safest
for patients.
Amgen has committed to make research results available to the public. This summary
has been provided as part of that commitment and should not be used for any other
purpose. It should not be considered to make a claim for any product or to guide
treatment decisions.
Who Sponsored This Study?
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA
Phone (United States): +1 805-447-1000
Phone. (United Kingdom): +44 1223 436441
Amgen Inc. is the sponsor of this study that tested rocatinlimab, a medicine which is
partnered with Kyowa Kirin Co., Ltd. Amgen would like to thank everyone who
participated in this study and feels it is important to share the results of this study.
General Information About the Clinical Study
Where and when was the study done?
This study took place in Argentina, Australia, Brazil, Canada, Hong Kong, South
Korea, Turkey, United Kingdom, and United States.
The study began in January 2023 and ended in July 2025.
The study was completed as planned.
Why was the study done?
Atopic dermatitis (AD), often referred to as eczema, is a chronic (long term),
inflammatory skin disease (a condition that makes your skin red and itchy) with
periods without symptoms and periods when the disease comes back.
The main purpose of the study was to see if rocatinlimab was safe and welltolerated,
in adolescents aged ≥ 12 to <18 years with moderate-to-severe AD. The
study also examined how rocatinlimab affects eczema symptoms.
Who Was Included in This Study?
Who took part in the study?
This study included 187 participants with moderate-to-severe AD. 96 participants
[(51.3%, or about 96 out of 187)] were male and 91 participants [(48.7%, or about
91 out of 187)] were female. They ranged in age from 12 to 17 years.
This study took place at 59 study centers across 9 countries.
The numbers of participants enrolled from each country are listed below:
Continent Country Number of Participants
North America
United States 41
Canada 29
Latin America
Brazil 30
Argentina 29
Europe
United Kingdom 4
Turkey 3
Asia Republic of Korea 29
Hong Kong 3
Oceania Australia 19
Study doctors examined participants and asked them to be in the study if they:
Were aged ≥ 12 to < 18 years.
Had been diagnosed with moderate-to-severe AD for at least 12 months before
signing informed consent. This was defined as:
An Eczema Area and Severity Index (EASI) score of 12 or higher (a score
used to measure how severe and widespread eczema is),
A validated Investigator’s Global Assessment for AD (vIGA-AD) score of 3 or
4 on a scale from 0 to 4, where 3 means moderate disease and 4 means
severe disease, and
≥ 10% of the body surface area was affected by AD at the initial screening
visit and again on day 1 before enrollment.
Which Medicines Were Studied?
In this study, all participants received rocatinlimab. Rocatinlimab is a laboratorymade
protein antibody discovered by Kyowa Kirin Co., Ltd. and co-developed by
Amgen Inc., a for-profit biopharmaceutical company. Rocatinlimab is designed
specifically to attach to and prevent the function of a protein named OX40 on cells
that are involved in inflammation, to reduce the activity and number of these cells.
Rocatinlimab is still being tested and is not approved by any regulatory health
agencies (like the Medicines and Healthcare products Regulatory Agency [MHRA])
for use in patients with AD.
This study was conducted in 3 parts:
screening period for up to 30 days to check eligibility.
treatment period of approximately 52 weeks, during which participants received rocatinlimab. safety follow-up, 16 weeks after the last dose of rocatinlimab, for participants who did not continue into the long-term maintenance study. A long-term maintenance study is when researchers keep checking how well a drug continues to work and how safe the drug is over a long period of time. Participants received rocatinlimab by injection subcutaneously (under the skin) at the start of the study, at weeks 0, 2, and 4, and then every 4 weeks for the total duration of 52 week treatment period."REC name
Wales REC 3
REC reference
23/WA/0075
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion