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)

Investigating the Effects of an Investigational Medication on Eosinophilic Esophagitis

Recruiting
18 years or above
All
Phase 4
64 participants needed
10 Locations

Study Overview

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).

Study Details

The duration per participant will be up to 152 weeks.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Eosinophilic Oesophagitis
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • A documented diagnosis of EoE by endoscopic biopsy.
  • Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration.
  • History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
  • Body weight ≥40 kg.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome).
  • Active Helicobacter pylori infection.
  • History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
  • Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening.
  • History of bleeding disorders or esophageal varices.
  • Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline.
  • Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening.
  • Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Updated on 18 Jun 2024. Study ID: NCT06101095

This study investigates the effects of an investigational medication on adults with eosinophilic esophagitis. Eosinophilic esophagitis is a condition where white blood cells called eosinophils build up in the esophagus, causing inflammation and swallowing difficulties. The purpose of this study is to evaluate how the investigational medication affects the function and structure of the esophagus in people with this condition.

Participants will be randomly assigned to one of two study arms. One arm will receive the investigational medication, while the other will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. After the initial treatment period, all participants will have the opportunity to receive the investigational medication in an open-label phase.

  • Who can participate: Adults with eosinophilic esophagitis and swallowing difficulties, weighing at least 40 kg with specific biopsy results, are eligible. Certain conditions and prior treatments may exclude participation.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. After the initial treatment phase, all participants will receive the investigational medication in an open-label phase.
  • Study Timelines and Visits: The study will last 152 weeks. The study requires 10 visits.

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