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Monoclonal Antibodies
Dupilumab for Eosinophilic Esophagitis (DESTRICT Trial)
Phase 4
Recruiting
Led By Evan S Dellon, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial aims to test how effective the drug dupilumab is in treating patients with severe strictures and active Eosinophilic Esophagitis. All participants will receive the drug and
Who is the study for?
This trial is for individuals with severe narrowing of the esophagus (strictures) due to Eosinophilic Esophagitis (EoE), a chronic allergic/immune condition. Participants must have active symptoms and will be screened with an endoscopy. The study requires weekly self-administered injections for one year, regular check-ups, blood tests, and additional endoscopies.
What is being tested?
The trial is testing Dupilumab, an FDA-approved drug, to see how effective it is in treating severe strictures caused by EoE. All participants will receive the drug through under-the-skin injections once a week for 52 weeks and their health progress will be monitored regularly.
What are the potential side effects?
Dupilumab may cause side effects such as injection site reactions (redness or swelling), cold sores in your mouth or on your lips, eye problems like redness or itching, joint pain(s), inflammation around the heart or lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Histologic Response to Dupilumab
Secondary study objectives
Change in Endoscopic Severity
Change in Histologic Severity
Change in Minimum Esophageal Caliber
+1 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open Label dupilumabExperimental Treatment1 Intervention
Open label dupilumab 300mg injection given subcutaneously weekly, for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,539 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,230 Patients Enrolled for Eosinophilic Esophagitis
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
386,472 Total Patients Enrolled
10 Trials studying Eosinophilic Esophagitis
1,355 Patients Enrolled for Eosinophilic Esophagitis
SanofiIndustry Sponsor
2,209 Previous Clinical Trials
4,039,736 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,263 Patients Enrolled for Eosinophilic Esophagitis
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