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

Investigating the Effect of Investigational Medication (Dupilumab) on Esophageal Function in Adults with Eosinophilic Esophagitis

Recruiting
18 years or above
All
Phase 4
64 participants needed
13 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 10 Apr 2025. Study ID: NCT06101095

This study investigates the effect of an investigational medication on esophageal function and remodeling in adults with eosinophilic esophagitis (EoE). EoE is a condition where a type of white blood cell called eosinophil builds up in the lining of the esophagus, causing inflammation. This can lead to difficulty swallowing and food getting stuck in the throat.

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 24 weeks, all participants will receive the investigational medication for an additional 104 weeks in an open-label phase. The study will include procedures like endoscopic biopsies to assess esophageal changes.

  • Who can participate: Adults with a documented diagnosis of eosinophilic esophagitis by endoscopic biopsy, who have experienced at least 2 episodes of difficulty swallowing solids per week in the last month, and weigh at least 40 kg, may be eligible. Participants must not have other causes of esophageal eosinophilia, certain other medical conditions, or recent use of certain medications.
  • Study details: Participants will be involved in a randomized, double-blind study, meaning neither the participants nor the researchers will know who is receiving the investigational medication or the placebo during the initial 24 weeks. Following this, all participants will receive the investigational medication in an open-label phase for 104 weeks.
  • Study Timelines and Visits: The study will last 152 weeks. The study requires 10 visits.

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