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A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis

NCT04849390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-11-14

No results posted yet for this study

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).

Conditions

  • Eosinophilic Esophagitis

Interventions

DRUG

ESO-101

Daily administration in the evening at bedtime for 28 days

DRUG

Placebo

Daily administration in the evening at bedtime for 28 days

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • FGK Representative Service B.V.

    collaborator UNKNOWN

  • EsoCap AG

    lead INDUSTRY

Principal Investigators

  • Isabelle Racamier · EsoCap AG (Malzgasse 9, 4052 Basel, Switzerland)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2023-10-09
Completion
2023-10-09

Countries

  • Germany
  • Netherlands
  • Poland
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849390 on ClinicalTrials.gov