drugset / Trial / 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)

NCT05724199

Phase 3 Completed 746 enrolled Amgen
RandomizedSequentialDouble-blindTreatment

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).

Timeline

Start
2023-02-21
Primary completion
2024-09-15
Completion
2024-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rocatinlimab Monoclonal antibody Subcutaneous

Indications