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
- NCT06101095
- EudraCT 2022-502491-23
- U1111-1280-5266
- 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.
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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
- Dupilumab Improves Esophageal Distensibility in EoE: 24-Week Results From the REMODEL Randomized Trial.The American journal of gastroenterology, 2026
- Record updated
- 30 September 2026