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Completed
NCT05724199
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
Conditions: Atopic Dermatitis
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 746
Sponsor: Amgen
Location: The University of Alabama at Birmingham Birmingham Alabama
Summary
The coprimary objectives of the study are 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™).
* 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).
Eligibility Criteria
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 12 months
* History of inadequate response to TCS of medium or higher potency (with or without TCI)
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 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 corticosteroids
* Nonbiologic, non-targeted Systemic immunosuppressants
* Phototherapy
* Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
* TCS
* TCI
* Topical phosphodiesterase type 4 inhibitors
* Other topical immunosuppressive agents
* Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Source: ClinicalTrials.gov (NCT05724199). StuddyBuddy aggregates publicly available trial information.