A Phase 3 Study of Rocatinlimab monotherapy vs placebo in Atopic Dermatitis (AD) (ROCKET-Horizon)
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) Monotherapy in Adult Subjects With Moderate to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
IRAS ID
1007109
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2022-000937-18
Clinicaltrials.gov Identifier
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 alone, compared to placebo.680 patients will be enrolled globally; patients will either receive a dose of rocatinlimab (3 in 4 chance) or placebo (1 in 4 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
Lay Summary:
"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
Phone (United States): 1 805-447-1000
Amgen Inc. is the sponsor of the study who made rocatinlimab the medicine tested in the study. Kyowa Kirin Co., Ltd, partnered with Amgen on this 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 Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Germany, Estonia, Finland, Japan, Mexico, Poland, Portugal, South Africa, Spain, Republic of Korea, Turkiye, the United Kingdom of Great Britain and Northern Ireland, and the United States.
• The study began in December 2022 and ended in August 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 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 rocatinlimab to placebo. A placebo does not contain any medicine and helps researchers compare the effects of a new medicine to taking no medicine.
• The main purpose of this study was to see if taking rocatinlimab improves the symptoms of atopic dermatitis better than placebo in patients with moderate-to-severe atopic dermatitis that did not get better with topical treatments (applied externally on the skin). Researchers also wanted to check how patients tolerated rocatinlimab compared to placebo and whether it caused any side effects.Who Was Included in This Study?
Who took part in the study?
This study included 726 participants with moderate-to-severe atopic dermatitis. 329 participants (45%, or about 45 out of every 100) were women and 397 participants (55%, or about 55 out of every 100) were men. They ranged in age from 18 to 85 years. 418 participants (58%, or about 58 out of every 100) were 39 years or younger, 265 participants (37%, or about 37 out of every 100) were older than 40 years old and younger than 65 years old and 43 participants (6%, or about 6 out of every 100) were 65 years or older.
This study took place at 151 study centers. The numbers of participants in each country are shown below:
Study doctors examined participants and chose them to be in the study if they:
• were 18 years 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 (drug therapies that work throughout the whole body)Which Medicines Were Studied?
• In this study, rocatinlimab was compared to placebo. Rocatinlimab, a protein discovered by Kyowa Kirin Co., Ltd, is being 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 Food and Drug Administration [FDA]) for use in patients with atopic dermatitis.
• This study had 3 parts:a screening part that lasted from 8 to 30 days,
a treatment part of approximately 24 weeks (where participants received the
study medicine, either rocatinlimab or placebo),
a follow up part, 16 weeks after the last dose of study medicine, for participants
who did not continue into the long-term maintenance study.
• Participants who completed the study had the option to enter a separate long-term maintenance study. A long-term maintenance study is when researchers keep checking how well something works over a long period of time.
• Participants received study medicine (either rocatinlimab or placebo) as an injection under the skin at week 0, 2, 4, and then every 4 weeks for a total duration of 24 weeks. Participants received the last dose of the study medicine at week 20.
Please see email to REC from rthoma09@amgen.com for remaining Lay Summary."REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0267
Date of REC Opinion
23 Aug 2023
REC opinion
Further Information Favourable Opinion