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 Esophageal Function in Adults with Eosinophilic Esophagitis
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
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Age: 18 years or above
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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
This study investigates the effects of an investigational medication on esophageal function and remodeling in adults with eosinophilic esophagitis (EoE). The purpose of this study is to understand how the investigational medication affects these symptoms compared to a placebo.
Participants in this study will be randomly assigned to receive either the investigational medication or a placebo for 24 weeks in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication. After this period, all participants will receive the investigational medication in an open-label phase for 104 weeks. The study includes site visits and may involve receiving the investigational medication directly at home.
- Who can participate: Adults with a documented diagnosis of eosinophilic esophagitis, who have experienced at least 2 episodes of difficulty swallowing solids per week in the past month, and weigh at least 40 kg are eligible to participate. Key exclusions include other causes of esophageal eosinophilia, active infections, or prior treatment with the investigational medication.
- Study details: Participants will be involved in a 24-week double-blind period where they will receive either an investigational medication or a placebo, followed by a 104-week open-label period where all participants receive the investigational medication. A placebo is an inactive substance that looks like the investigational medicine but does not contain any active ingredients.
- Study timelines and visits: The study will last 152 weeks. The study requires 10 visits.
