Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT06101095
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06101095
Study Brief:
Protocol Section:
NCT06101095