Actively Recruiting
Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
Led by University of California, San Diego · Updated on 2024-12-11
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and available for the entire study duration
- Aged between 22 and 75 years, any gender and ethnicity
- Diagnosed with proton pump inhibitor resistant eosinophilic esophagitis confirmed by biopsy showing more than 15 eosinophils per high power field before and 8 weeks after PPI treatment
- Ability and willingness to take weekly subcutaneous injections of Dupilumab for 12 weeks
- No use of inhaled, oral, or intravenous steroids for at least 8 weeks before the study
You will not qualify if you...
- Previous or current treatment with Dupilumab or participation in a Dupilumab clinical trial
- Changes in food elimination diet within 6 weeks before screening; must remain on the same diet during the study
- Other causes of esophageal eosinophilia such as hyper eosinophilic syndrome or Churg-Strauss syndrome
- Active Helicobacter pylori infection, achalasia, Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
- Significant medical conditions preventing treatment or follow-up
- Changes in certain medications including proton pump inhibitors, leukotriene inhibitors, corticosteroids, or immunotherapy within specified time frames before baseline
- Treatment with systemic immunosuppressants or investigational drugs within defined periods prior to study
- Planned major surgery or use of prohibited medications during the study
- Recent live vaccine within 4 weeks prior to baseline
- Active or suspected parasitic infection or recent serious infections
- Known immunodeficiency disorders or history of specific infections
- History of HIV, hepatitis B or C infection with active disease
- Current significant liver disease or abnormal lab values indicating blood or kidney issues
- Unstable asthma or atopic conditions without investigator approval
- Severe illnesses that may affect study participation
- History of cancer within 5 years except certain treated skin or cervical cancers
- Recent history of alcohol or drug abuse
- Any medical or psychological condition judged unsuitable by investigator
- Investigator team members or immediate family
- Pregnant or breastfeeding women or women not agreeing to effective contraception
- Known allergy or hypersensitivity to Dupilumab or its ingredients
- Need for esophageal dilation during treatment with Dupilumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California San Diego (UCSD) Health Medical center
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
A
Anant Gupta, MBBS
CONTACT
R
Ravinder Mittal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here