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
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.
REC name
HSC REC A
REC reference
23/NI/0021
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion