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Monoclonal Antibodies

Open Label dupilumab for Eosinophilic Esophagitis (DESTRICT Trial)

Phase 4

Waitlist Available

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

DESTRICT 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.Check my eligibility

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.See study design

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.

DESTRICT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Histologic Response to Dupilumab

Secondary outcome measures

Change in Endoscopic Severity

Change in Histologic Severity

Change in Minimum Esophageal Caliber

+1 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

12%

Accidental Overdose

Conjunctivitis

Nasopharyngitis

Headache

Dermatitis Atopic

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

OLE Period: Dupilumab/Dupilumab

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

DESTRICT 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

~12230

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor

622 Previous Clinical Trials

380,701 Total Patients Enrolled

7 Trials studying Eosinophilic Esophagitis

884 Patients Enrolled for Eosinophilic Esophagitis

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,795 Total Patients Enrolled

7 Trials studying Eosinophilic Esophagitis

1,230 Patients Enrolled for Eosinophilic Esophagitis

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,950 Total Patients Enrolled

5 Trials studying Eosinophilic Esophagitis

813 Patients Enrolled for Eosinophilic Esophagitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for participants in this clinical trial?

"As per clinicaltrials.gov, this study is currently not enrolling participants. Originally posted on April 1st, 2024, with the latest update made on April 5th, 2024. However, there are numerous other studies available for patient recruitment; specifically, there are 264 ongoing trials seeking candidates at present."

Answered by AI