A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

Summary

This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) * Screening period: Up to 12 weeks before Week 0 * Randomized double-blind period: 24 weeks * Open label period: 104 weeks * Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).

Timeline

Start

2023-11-29

Primary completion

2025-11-05

Completion

2028-02-01

Publications

• Dellon ES, Savarino EV, Zaghloul S, Angello JT, Zhang M, Raphael BP, Radwan A, Bredenoord AJ. Study design of the phase IV, randomized, placebo-controlled REMOdeling with Dupilumab in Eosinophilic esophagitis Long-term (REMODEL) trial. Ther Adv Gastroenterol. 2025 Oct 9;18:17562848251383782. doi: 10.1177/17562848251383782. eCollection 2025.

Drugs

Indications