A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

The coprimary objectives of the study are to:To evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).To evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI 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 (American Academy of Dermatology) Consensus Criteria (2014) present for at least 6 monthsHistory of inadequate response to TCS of medium or higher potency within 6 months (with or without 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:TCSTCIAnti-pruritic agentsTopical phosphodiesterase type 4 inhibitorsOther topical immunosuppressive agentsCombination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents