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NCT05704738
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)
Conditions: Atopic Dermatitis
Sex: All
Ages: 12 Years – 17 Years
Phase: PHASE3
Enrollment: 500
Sponsor: Amgen
Location: United States
Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.
Eligibility Criteria
Inclusion Criteria:Age ≥ 12 to < 18 years at Day 1.Body weight ≥ 40 kg at screening.History of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI).EASI score ≥ 16.vIGA-AD score ≥ 3.≥10% body surface area (BSA) of AD involvement.Worst pruritus NRS ≥ 4.Exclusion Criteria:Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1.Treatment 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 medications or therapies within 1 week, prior to Day 1:TCSTCITopical phosphodiesterase type 4 inhibitorsOther topical immunosuppressive agents
Source: ClinicalTrials.gov (NCT05704738). StuddyBuddy aggregates publicly available trial information.