A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Summary
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: * Placebo for Induction and Maintenance * CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance * CC-93538 360 mg SC once weekly for Induction and Maintenance
Timeline
- Start
- 2021-02-22
- Primary completion
- 2024-01-11
- Completion
- 2024-08-29
Outcome
Met primary endpoint
registry Induction Phase - CC-93538 360 mg QW vs Induction Phase - Placebo; p = 0.0005; Difference in Least Square Mean -1.91 (95% CI -2.97 to -0.84) NCT04753697 ↗
registry Induction Phase - CC-93538 360 mg QW vs Induction Phase - Placebo; p <0.0001; Difference in percentage 26.4 (95% CI 20.6 to 32.2) NCT04753697 ↗
release “The pivotal Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with EoE met both co-primary endpoints.” bms.com ↗
Publications
- Dellon ES, Charriez CM, Zhang S, Falk GW, Oliva S, Ma C, Siffledeen J, Schroeder S, Philpott H, Vanuytsel T, Abe Y, Li K, Zema CL, Venkatasamy A, Yeshokumar AK, Oh YS, Schoepfer A. Cendakimab in Adults and Adolescents with Eosinophilic Esophagitis. NEJM Evid. 2025 Oct;4(10):EVIDoa2500095. doi: 10.1056/EVIDoa2500095. Epub 2025 Sep 23.
- Charriez CM, Zhang S, de Oliveira CHMC, Patel V, Oh YS, Hirano I, Schoepfer A, Dellon ES. Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis. Contemp Clin Trials. 2024 Dec;147:107708. doi: 10.1016/j.cct.2024.107708. Epub 2024 Oct 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cendakimab | Monoclonal antibody | 360 mg | Subcutaneous |