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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
With
Regeneron Pharmaceuticals
The duration per participant will be up to 152 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | 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)
