Mepo for Eosinophilic Esophagitis (EoE) Study

NCT03656380 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-08-23

Study results available
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Summary

Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis (EoE) after an initial 3 month treatment course, and will also assess the impact of an additional 3 months of treatment.

Conditions

  • EoE
  • Eosinophilic Esophagitis

Interventions

DRUG

Mepolizumab 300 mg

Mepolizumab 300 mg subcutaneous injection

DRUG

Mepolizumab 100 mg

Mepolizumab 100 mg subcutaneous injection

OTHER

Placebo

Saline subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Evan S Dellon, MD, MPH · UNC Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2022-06-06
Completion
2022-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03656380 on ClinicalTrials.gov