Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06665971
Phase
PHASE4
Status
Recruiting
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Conditions

  • Eosinophilic Esophagitis (EoE)

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this study is to research Dupilumab, an FDA approved medication in treating patients diagnosed with Eosinophilic esophagitis (EoE). The drug works by controlling allergic inflammation of the esophagus. The esophagus is a food pipe that transfers food from the mouth into the stomach. Participants with EoE have dysfunction of the muscle of the esophagus (impaired peristalsis) that is not favorable for the transport function. Main question this study aims to answer is: Whether Dupilumab helps improve muscle activity of the esophagus in participants with EOE? Participants will: Take Dupilumab every week for 12 weeks. Visit the clinic before and after starting the medication. Keep a diary of symptoms.

Key Dates

Start date
Nov 10, 2024
Status verified
Oct 2024
Primary completion
Sep 15, 2026
Completion
Nov 14, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EoE participants treated with Dupilumab
    All the participants will be treated with once a week subcutaneous injection of Dupilumab 300 mg through for 12 weeks. There is no placebo arm in the study.

Primary Outcome Measure

To determine the change in the peak esophageal muscle thickness during peristalsis following 12 weeks of Dupilumab [ Time Frame: From baseline assesment at 2 weeks to the end of the study at 14 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego (UCSD) Health Medical centerLa JollaCalifornia92037
Anant Gupta, MBBS
[email protected]
314-685-9214
Ravinder Mittal, MD
[email protected]
858-534-3328

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By research site
University of California San Diego (UCSD) Health Medical center· La Jolla, CA

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