At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Rocatinlimab and Placebo for Atopic Dermatitis. Completed, enrolled 726 participants across 197 sites in 21 countries.
Signals
Detailed Summary
The co-primary objectives of the study are to: * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
Study Details
Timeline
Arms & Interventions
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Placebo Q4W for 24 weeks with a loading dose at Week 2.
Interventions
Rocatinlimab will be administered through a subcutaneous (SC) injection.
The matching placebo will be administered through a SC injection.