A Phase 3 Study to Evaluate the Safety and Effectiveness of Depemokimab Compared to Placebo in Adults with Hypereosinophilic Syndrome

What this Trial Is About

Researchers are evaluating depemokimab in adults with hypereosinophilic syndrome HES who have uncontrolled disease despite standard care therapy. This phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter study focuses on adults with confirmed HES diagnosis, a history of repeated flares two or more in the past 12 months, and a blood eosinophil count of at least 1,000 cellsL. The goal is to assess the efficacy and safety of depemokimab in reducing HES flares compared to placebo while continuing standard care treatment. Participants will be randomly assigned in a 21 ratio to receive either depemokimab or a matching placebo. Both groups will continue their stable standard of care HES therapy during the 52-week treatment period. Depemokimab or placebo is administered under blinded conditions, and participants will be monitored throughout the study to evaluate treatment effects and safety. Throughout the 52 weeks, participants will have regular assessments including monitoring the frequency and timing of HES flares, fatigue levels measured by the Brief Fatigue Inventory, and other safety evaluations. The primary outcome is the frequency of HES flares up to 52 weeks. Secondary outcomes include time to first flare, number of participants experiencing flares, and changes in fatigue scores. Safety and tolerability will also be closely monitored during the study period.

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial