Phase 3 Long-term Study of Rocatinlimab in Participants with Atopic Dermatitis (AD) (ROCKET-ASCEND)
Research type
Research Study
Full title
A Phase 3, Multicenter, Double blind Maintenance Study to Assess Long term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate to severe Atopic Dermatitis (AD) (ROCKET ASCEND)
IRAS ID
1007725
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Clinicaltrials.gov Identifier
Research summary
Atopic Dermatitis (AD) is a chronic inflammatory skin disease that causes dry scaly skin and itching. It affects approximately 10% of adults and 20% of children.
The study drug aims to reduce inflammation. Improvements in severity of AD were observed in previous studies compared to an inactive ingredient (placebo).
This study will include approximately 2200 adults and children (13+) with moderate-to-severe AD. It will only include patients who completed a parent study. The aim is to assess long-term safety, how patients feel and how effective it is.
The study includes different doses and will look at how well the response is maintained in patients who receive placebo after they have previously responded.
Patients completing the adult studies who show a response without using additional treatments (other than those allowed) will be assigned to either 300mg every 4 weeks (Q4W), 300mg every 8 weeks (Q8W), 150mg Q4W, 150mg Q8W or placebo for 104 weeks. These patients will be blinded (they will not know what they receive).
All remaining adult patients will receive 300mg Q4W for 104 weeks. These patients will not be blinded.
If patients on blinded treatments relapse (their AD worsens) or require rescue treatments (additional treatments to treat AD), they will be able to receive 300mg Q4W for the rest of the study.
Patients completing the adolescent study will receive 300mg Q4W for 76 weeks. These patients will not be blinded.
Safety will be measured by the number and nature of serious and adverse events experienced globally. Effectiveness will be measured using the Eczema Area and Severity Index (EASI), Validated Investigator’s Global Assessment for AD (vIGA-ADTM) and daily worst pruritus (itch) Numeric Rating Scale. Other questionnaires will be completed by investigator and patients, including one about their mental health.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0174
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion