NCT04753697

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

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 Subjects With Eosinophilic Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	CC-93538	Subcutaneous
OTHER	Placebo	Subcutaneous

Timeline

• Start date: 2021-02-22
• Primary completion: 2024-01-11
• Completion: 2024-08-29
• First posted: 2021-02-15
• Last updated: 2025-03-13
• Results posted: 2025-03-13

Locations

212 sites across 15 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study