Last updated 40 days ago
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)
64 patients around the world
Available in Brazil, United States
The duration per participant will be up to 152 weeks.
Sanofi
1Research sites
64Patients around the world
This study is for people with
Esophagitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 to 10 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.
Sites
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
SponsorSanofi
Conditions
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06101095
