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Assessing esophageal function with dupilumab in adults with eosinophilic esophagitis

A Phase 4, Randomized, Multicenter, Double-blind, Parallel-group, 24 Weeks, Placebo-controlled Study Followed by 104 Weeks Open-label to Assess Dupilumab Efficacy on Esophageal Function and Remodeling in Adult Participants With Eosinophilic Esophagitis (EoE)

Phase 4 Interventional Sanofi · NCT06101095

This study is testing if the medication dupilumab can improve esophageal function and symptoms in adults with eosinophilic esophagitis over two years.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment64 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsdupilumab
Locations30 sites (Murrieta, California and 29 other locations)
Trial IDNCT06101095 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of dupilumab on esophageal function and remodeling in adults diagnosed with eosinophilic esophagitis (EoE). It consists of a 24-week randomized, double-blind, placebo-controlled phase followed by a 104-week open-label phase, totaling 128 weeks of treatment. Participants will undergo multiple site visits and receive either the active drug or a placebo during the initial phase. The study aims to provide insights into the long-term benefits of dupilumab for managing EoE symptoms and improving esophageal health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a documented diagnosis of eosinophilic esophagitis who experience frequent episodes of dysphagia.

Not a fit: Patients with other causes of esophageal eosinophilia or significant esophageal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from eosinophilic esophagitis by alleviating symptoms and enhancing esophageal function.

How similar studies have performed: Other studies have shown promise in using dupilumab for similar conditions, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Murrieta, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Eosinophilic Oesophagitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.