Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Eosinophilic Oesophagitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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) fo...
Detailed Description
The duration per participant will be up to 152 weeks.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2028
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06101095
Start Date
November 29 2023
End Date
February 1 2028
Last Update
December 23 2025
Active Locations (30)
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1
United Gastroenterologists - Murrieta- Site Number : 8400001
Murrieta, California, United States, 92563
2
University of California San Francisco - Parnassus Heights- Site Number : 8400020
San Francisco, California, United States, 94143
3
Borland Groover Clinic- Site Number : 8400016
Jacksonville, Florida, United States, 32256
4
Treasure Valley Medical Research- Site Number : 8400018
Boise, Idaho, United States, 83706