Sign in
Active, not recruitingPhase 4

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)

Key facts

Who runs it
Sanofi
Where
Boise, Chapel Hill, Chicago, Cleveland, Glenview, Gurnee, Houston, Iowa City, Jacksonville, Mansfield, Murrieta, Philadelphia, Rochester, San Francisco, and Worcester, United StatesSee the 15 sitesAlso in 4 other countries, 15 sites
Trial code
Status
Active, not recruiting
Phase
Phase 4
People taking part
69 people enrolled
Started
29 Nov 2023
Expected to end
1 Feb 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Dupilumab
  • Placebo
Record updated
30 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
  • 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
  • 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 bleeding disorders or esophageal varices
  • Participants are excluded from the study if any of the following criteria apply:
  • 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

Where in United States

Also in 4 other countries, 15 sites

  • Treasure Valley Medical Research- Site Number : 8400018Boise, United States
  • University of North Carolina at Chapel Hill- Site Number : 8400007Chapel Hill, United States
  • Northwestern University- Site Number : 8400003Chicago, United States
  • Cleveland Clinic - Cleveland- Site Number : 8400009Cleveland, United States
  • GI Alliance - Glenview- Site Number : 8400012Glenview, United States
  • Gurnee, IllinoisHospital not named in the registry
  • Private Practice - Dr. Martin Yudovich- Site Number : 8400015Houston, United States
  • University of Iowa- Site Number : 8400006Iowa City, United States
  • Borland Groover Clinic- Site Number : 8400016Jacksonville, United States
  • GI Alliance - Mansfield- Site Number : 8400017Mansfield, United States
  • United Gastroenterologists - Murrieta- Site Number : 8400001Murrieta, United States
  • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400010Philadelphia, United States
  • Mayo Clinic Hospital Rochester- Site Number : 8400008Rochester, United States
  • University of California San Francisco - Parnassus Heights- Site Number : 8400020San Francisco, United States
  • University of Massachusetts Chan Medical School- Site Number : 8400019Worcester, United States

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • DupilumabTreatment being tested

    Subcutaneous injection (SC) as per protocol

  • PlaceboPlacebo, for comparison

    SC injection as per protocol

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Publications
Record updated
30 September 2026