A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a randomized, placebo-controlled, double-blind trial to evaluate the efficacy,
tolerability, and safety of ESO-101 in adult patients with active eosinophilic esophagitis
(EoE). Patients will be screened at 2 visits (Visit 1 and Visit 2) during which their
eligibility will be assessed based on endoscopy-independent criteria (Visit 1) and based on
the histologic assessment of esophageal biopsy samples taken during the screening endoscopy
(Visit 2). Eligible patients will be randomized 2:1 to once-daily treatment with ESO-101 or
placebo and treated for 28 days starting on Day 0. Further clinic visits will be performed at
Day 14 (Visit 4) and Day 28 (Visit 5, end of treatment) to assess the efficacy, tolerability,
and safety. In addition, a safety follow-up call will be scheduled 2 weeks after the end of
treatment (Day 42, Visit 6).
Phase:
Phase 2
Details
Lead Sponsor:
EsoCap AG
Collaborators:
FGK Clinical Research GmbH FGK Representative Service B.V.