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
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