Mepo for Eosinophilic Esophagitis (EoE) Study
NCT03656380 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2023-08-23
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
- collaborator INDUSTRY
- collaborator OTHER
- collaborator OTHER
-
MNGI Digestive Health, P.A.
collaborator OTHER -
University of North Carolina, Chapel Hill
lead OTHER
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
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