A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

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).

Inclusion Criteria:Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 6 monthsHistory of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])EASI score ≥16vIGA-AD score ≥3≥10% body surface area (BSA) of AD involvementWorst pruritus numerical rating scale ≥ 4Exclusion Criteria:Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:Systemic corticosteroidsSystemic immunosuppressantsPhototherapyJanus kinase inhibitorsTreatment with any of the following medications or therapies within 1 week, prior to Day 1:TCS of any potencyTCITopical phosphodiesterase type 4 inhibitorsOther topical immunosuppressive agents