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 Treatment for Eosinophilic Esophagitis (EoE)
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
-
Age: 18 years or above
-
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 tissue changes in adults with eosinophilic esophagitis (EoE). EoE is a condition where a type of white blood cell, called eosinophils, builds up in the esophagus, leading to inflammation and difficulty swallowing. The study aims to understand how the investigational medication can impact these symptoms and the esophagus itself.
Participants will undergo various procedures during the study. Initially, there will be a screening period to confirm eligibility. The study includes a double-blind phase where participants receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. This is followed by an open-label phase where all participants receive the investigational medication. Regular site visits and some direct-to-participant deliveries of the investigational medication are part of the study procedures.
- Who can participate: Adults with a documented diagnosis of eosinophilic esophagitis, weighing at least 40 kg, and experiencing at least 2 episodes of difficulty swallowing per week. Participants must not have other causes of esophageal eosinophilia or certain other medical conditions.
- Study Details: Participants will be involved in a double-blind phase with either the investigational medication or a placebo, followed by an open-label phase with the investigational medication.
- Study Timelines and Visits: The study will last 152 weeks.The study requires 10 visits.
Find a Study Location to Connect
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
