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)

Conditions

• Eosinophilic Oesophagitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Subcutaneous injection (SC) as per protocol
• Placebo — DRUG
  SC injection as per protocol

Study Details

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).

Key Dates

Start date

Nov 29, 2023

Status verified

Dec 2025

Primary completion

Nov 5, 2025

Completion

Feb 1, 2028

Study Design

Enrollment

69 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Subcutaneous injection (SC) as per protocol
• Placebo Comparator: Placebo
  SC injection as per protocol

Primary Outcome Measure

Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP) [ Time Frame: From baseline to Week 24 ]

Locations (15)

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