Phase 3 Study Assessing Rocatinlimab in Adolescents With Atopic Dermatitis (ROCKET-Orbit)
Research type
Research Study
Full title
A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
IRAS ID
1006787
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2022-001548-99
Clinicaltrials.gov Identifier
Research summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 20% of adolescents and is a condition that causes dry scaly skin and itching. \n\nRocatinlimab looks to reduce inflammation. Improvements in severity of AD were observed in previous studies of rocatinlimab compared to an inactive ingredient (placebo). \n\nThis study will be conducted in adolescent patients who are aged 12 or older but younger than 18 years old with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications (applied externally on the skin). \n\nThe aim of the study is to confirm the safety and how someone feels while taking rocatinlimab. \n\n170 patients will be enrolled globally; patients will receive a set dose of rocatinlimab by injection under the skin every 4 weeks for 52 weeks with an additional dose at week 2. After 6 weeks, if patient’s AD returns or gets worse, they may, in addition, receive rescue medication and/or therapy. \n\nSafety 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) 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. Participants will also complete questionnaires at various time point during the study. \n\nOnce 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
Wales REC 3
REC reference
23/WA/0075
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion