A Phase 3 Study of Roctinlimab, Corticosteroids and/or Calcineurin Inhibitors in AD (ROCKET-Shuttle)
Research type
Research Study
Full title
A Phase 3, Randomized, 24-week, Placebo controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (ROCKET-Shuttle)
IRAS ID
1005863
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2022-000930-41
Clinicaltrials.gov Identifier
Research summary
Research Summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting 10% of adults and is a condition that causes dry scaly skin and itching. Of these patients, approximately one third have moderate to severe disease.
Rocatinlimab looks to reduce inflammation. Improvements in severity of AD were observed in previous studies of rocatinlimab compared to an inactive ingredient (placebo).
This study will be conducted in adult patients with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications (applied externally on the skin).
The aim of the study is to confirm the effectiveness, safety, and tolerability of rocatinlimab compared to placebo in combination with topical (applied directly to skin) corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) (a medication that alters the immune system to stop a certain chemical that may cause flare ups).715 patients will be enrolled globally; patients will either receive a higher or lower dose of rocatinlimab (5 in 7 chance) or placebo (2 in 7 chance) by injection under the skin every 4 weeks for 24 weeks. After 6 weeks, if patients relapse and their AD gets worse, they may in addition receive rescue medication and/or therapy.
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.
Once 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, Randomized, 24-week, Placebo controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Brief Title:
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Protocol Number: 20210144
EU Clinical Trial Number: 2022-501585-22
Other Identifiers: NCT05724199
Date of this Summary: 30 October 2025
What does this summary cover?
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
Tel. (United Kingdom): +44 1223 436441
Amgen Inc. is the sponsor of the study and partnered with Kyowa Kirin Co., Ltd, to study rocatinlimab, the medicine tested in the study. 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, Austria, Belgium, Bulgaria, Canada, China, France, Germany, Greece, Hungary, Italy, Japan, Malaysia, Netherlands, Poland, Singapore, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom of Great Britain and Northern Ireland, and United States.
The study began in February 2023 and ended in December 2024.
The study was completed as planned.
Why was the study done?
Atopic dermatitis (often referred to as eczema) is a chronic, inflammatory skin disease (a condition that makes your skin red and itchy) with periods without symptoms and periods when the disease comes back.
This was a phase 3 study, the late stage of the development process of medicines for humans. Researchers compared the new study medicine, rocatinlimab, in combination with topical (applied directly on the skin) corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) (these are approved medicines that alter the immune system to reduce flare-ups) to placebo in combination with TCS/TCI. A placebo does not contain any active medicine but looks like the medicine being tested. Including the placebo in the study helps researchers compare the effects of a new medicine to taking an inactive medicine.
The main purpose of this study was to see if taking rocatinlimab in combination with TCS and/or TCI improves the symptoms of atopic dermatitis in patients with moderate-to-severe atopic dermatitis that did not get better with topical treatments alone. Results were compared to patients who took placebo in combination with TCS and/or TCI.
Who was included in this Study?
Who took part in the study?
This study included 746 participants with moderate-to-severe atopic dermatitis. 303 participants (41%, or about 41 out of every 100) were women and 443 participants (59%, or about 59 out of every 100) were men. They ranged in age from 18 to 85 years. 437 participants (59%, or about 59 out of every 100) were 39 years or younger, 273 participants (37%, or about 37 out of every 100) were 40 years old to 64 years old and 36 participants (5%, or about 5 out of every 100) were 65 years or older.
Study doctors examined participants and chose them to be in the study if they:
were 18 years of age or older
had moderate-to-severe atopic dermatitis that was diagnosed at least 12 months before the start of the study and that did not get better with topical treatments or with systemic therapy. Systemic therapies are medicines that can be taken by mouth, like a tablet or a capsule, or as an injection. Systemic therapies work throughout the whole body.
This study took place at 180 study centres. The number of participants in each country is shown below:
NORTH AMERICA
Canada: 128
United States: 115
LATIN AMERICA
Argentina: 35
EUROPE
Austria: 18
Belgium: 4
Bulgaria: 24
France: 45
Germany: 19
Greece: 7
Hungary: 30
Italy: 5
The Netherlands: 16
Poland: 73
Spain: 2
Slovakia: 6
Slovenia: 4
Switzerland: 7
Turkey: 10
United Kingdom of Great Britain and Northern Ireland: 7
ASIA
China: 47
Japan: 100
Malaysia: 16
Singapore: 14
OCEANIA
Australia: 14REC name
HSC REC A
REC reference
23/NI/0021
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion