← Back to all trials
Recruiting
NCT05633355
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Conditions: Atopic Dermatitis
Sex: All
Ages: 12 Years – 17 Years
Phase: PHASE3
Enrollment: 170
Sponsor: Amgen
Location: United States
Summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Eligibility Criteria
Inclusion Criteria:Age ≥ 12 to < 18 years at day 1.Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 6 months before signing of informed consentHistory of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])Eczema Area and Severity Index (EASI) score ≥ 16vIGA-AD score ≥ 3≥ 10% BSA of AD involvement at day 1 pre-enrollmentExclusion 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 immunosuppressantsPhototherapyOral or topical janus kinase inhibitorsTreatment with any of the following agents within 1 week before day 1 pre-enrollment:TCSTCIAnti-pruritic agentsTopical phosphodiesterase type 4 (PDE4) inhibitorsOther topical immunosuppressive agentsCombination topical agents
Source: ClinicalTrials.gov (NCT05633355). StuddyBuddy aggregates publicly available trial information.