CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Mepolizumab 300 mg +2 moredrug
Likely dose
Mepolizumab 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03656380
NCT03656380Phase 2Completed
CompareCT.gov

A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms

University of North Carolina, Chapel Hill·interventional·Posted Sep 4, 2018·Updated Aug 23, 2023

In Brief

A Phase 2 clinical trial evaluating Mepolizumab 300 mg, Mepolizumab 100 mg, and 1 other intervention for EoE and Eosinophilic Esophagitis. Completed, enrolled 66 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEoE, Eosinophilic Esophagitis
CountriesUnited States
CollaboratorsGlaxoSmithKline, University of Utah, Northwestern University, MNGI Digestive Health, P.A.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 4, 2018
Enrollment StartMar 20, 2019
Primary CompletionJun 6, 2022
Study CompletionDec 9, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.8 years ago

Interventions

Mepolizumab 300 mgdrug

Mepolizumab 300 mg subcutaneous injection

Mepolizumab 100 mgdrug

Mepolizumab 100 mg subcutaneous injection

Placeboother

Saline subcutaneous injection