drugset / Trial / NCT05214768

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis

NCT05214768 ↗

Phase 3 Completed 48 enrolled Celgene Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.

Timeline

Start
2022-03-04
Primary completion
2024-07-02
Completion
2025-08-22

Outcome

Met primary endpoint

registry analysis (superiority test); CC-93538 360 mg QW vs Placebo; p = 0.003; Least Square Mean Difference -223.2 (95% CI -370.2 to -76.3); ANCOVA NCT05214768 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cendakimab Monoclonal antibody — —