Mepo for Eosinophilic Esophagitis (EoE) Study

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byEvan S Dellon, MD, MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Evan S Dellon, MD, MPH

Principal Investigator

UNC Chapel Hill

Eligibility Criteria

Inclusion Criteria

Age 16-75

Diagnosis of EoE as per consensus guidelines (including PPI non-response)*

Active eosinophilia on esophageal biopsy, with a peak count of least 15 EOS/hpf from at least one esophageal level.

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Treatment Details

Interventions

Mepolizumab (Monoclonal Antibodies)
Placebo (Other)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Placebo, followed by Mepolizumab 100 mgExperimental Treatment2 Interventions

This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.

Group II: Mepolizumab 300 mgExperimental Treatment1 Intervention

Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months