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Monoclonal Antibodies
Dupilumab vs Fluticasone for Esophagitis (DeTECTS Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight ≥40 kg at the time of screening visit
Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening
Must not have
Esophageal dilation performed at index endoscopy
Patients who have received dupilumab in the past 12 months for any indication are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to the end of treatment at week 16.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if dupilumab or swallowed topical fluticasone is better at improving the diameter of the esophagus and reducing inflammation. Researchers will compare dupilumab
Who is the study for?
This trial is for individuals with Eosinophilic Esophagitis, a condition where the esophagus becomes inflamed with eosinophils. Participants will be involved in the study for about one year and must be willing to undergo random assignment to treatments, attend eight study visits, complete questionnaires, have an endoscopy with biopsies and EndoFLIP measurements, as well as swallow an Esophageal String Test.
What is being tested?
The trial aims to determine whether dupilumab (300 mg weekly) or swallowed topical fluticasone (twice daily) is more effective at improving the diameter of the esophagus and reducing inflammation. It also assesses if such comparative clinical trials are feasible in this patient group.
What are the potential side effects?
Potential side effects from dupilumab may include allergic reactions, eye problems, joint pain or skin issues. Swallowed fluticasone could cause fungal infections in the mouth or throat, coughing and hoarseness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 40 kg.
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I have experienced swallowing difficulties at least twice a week in the last month.
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I am between 12 and 25 years old.
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My biopsy shows I have EoE with more than 15 eosinophils per high power field.
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My screening showed severe narrowing or blockage in my esophagus.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had my esophagus stretched during my first endoscopy.
Select...
I have not taken dupilumab in the last year.
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I have a history of esophageal disease, liver disease, inflammatory bowel disease, connective tissue disorder, or bleeding disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this will be measured at week 16 end of treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be measured at week 16 end of treatment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Esophageal Lumen Distensibility
Reduction of epithelial eosinophilia to < 15 eos/hpf (binary)
Secondary study objectives
Change in daily symptom questionnaire (DSQ) severity score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: dupilumab (also known as Dupixent)Active Control1 Intervention
Group II: fluticasone (also known as Flovent)Active Control1 Intervention
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,036 Total Patients Enrolled
13 Trials studying Eosinophilic Esophagitis
3,268 Patients Enrolled for Eosinophilic Esophagitis
University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,186 Total Patients Enrolled
8 Trials studying Eosinophilic Esophagitis
1,751 Patients Enrolled for Eosinophilic Esophagitis