A Phase 3 Study of Rocatinlimab monotherapy in Atopic Dermatitis (AD) (ROCKET-Ignite)
Research type
Research Study
Full title
A Phase 3, 24-week, Randomized, 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 Ignite)
IRAS ID
1007111
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2022-000711-31
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.
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 safety and how someone feels while taking rocatinlimab.Approximately 700 patients will be enrolled globally; patients will receive either a higher dose of rocatinlimab, a lower dose of rocatinlimab or placebo (an inactive ingredient) by injection under the skin every 4 weeks for 24 weeks with an additional dose at week 2. During the study, if a patient’s AD returns or gets worse, they may, in addition, receive rescue medication and/or therapy.
Safety 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), 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. Other questionnaires will also be performed by investigators. Participants will also complete questionnaires at various time point during the study, including questionnaires which evaluate itching, skin pain and their mental health.
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
West of Scotland REC 1
REC reference
23/WS/0072
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion