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Monoclonal Antibodies

Dupilumab for Eosinophilic Esophagitis

Phase 3
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
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 at week 52
Awards & highlights

Study Summary

This study is evaluating whether dupilumab is safe and effective in treating people with EoE.

Eligible Conditions
  • Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24
Secondary outcome measures
Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24
Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24
Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24
+28 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
12%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
OLE Period: Dupilumab/Dupilumab
OLE Period: Placebo/Dupilumab
DB Period: Dupilumab

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C: DupilumabExperimental Treatment1 Intervention
Part C is a 28-week extended active treatment period. Participants will receive dupilumab dosing regimen 1, dupilumab dosing regimen 2. At the end of the treatment period (week 52), participants will enter a 12-week follow-up period.
Group II: Part B: Dupilumab or PlaceboExperimental Treatment2 Interventions
Part B consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab dosing regimen 1, dupilumab dosing regimen 2 or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Group III: Part A: Dupilumab or PlaceboExperimental Treatment2 Interventions
Part A consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
621 Previous Clinical Trials
380,284 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
593 Patients Enrolled for Eosinophilic Esophagitis
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,659 Total Patients Enrolled
5 Trials studying Eosinophilic Esophagitis
522 Patients Enrolled for Eosinophilic Esophagitis
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
251,093 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
428 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.
Recent research and studies
clinicaltrials.govStudy
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
2018. "Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03633617.
~49 spots leftby Apr 2025
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