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Monoclonal Antibodies

Dupilumab for Esophagitis

Phase 4
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening
Body weight ≥40 kg
Must not have
Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome)
History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 24, 76 and 128
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will last for 2.5 years and will study the effects of a drug called dupilumab on esophageal function in adults with eosinophilic esophagitis.

Who is the study for?
Adults with a confirmed diagnosis of Eosinophilic Esophagitis (EoE) who experience at least two episodes of difficulty swallowing solid food per week and weigh over 40 kg can join. Those without proper biopsy confirmation or outside the weight criteria cannot participate.
What is being tested?
The study is testing Dupilumab against a placebo to see its effects on esophageal function in EoE patients. Initially, participants are randomly assigned to receive either Dupilumab or placebo for six months, followed by everyone receiving Dupilumab for an additional two years.
What are the potential side effects?
Dupilumab may cause side effects such as allergic reactions at the injection site, cold sores in your mouth or throat, and eye problems like redness, itching, or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had trouble swallowing solids at least twice a week in the last month.
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I weigh at least 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have conditions like hypereosinophilic syndrome or Churg Strauss syndrome.
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I have a history of specific digestive system conditions or surgeries.
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I have a history of bleeding disorders or esophageal varices.
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I have taken corticosteroids by mouth in the last 8 weeks.
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I have been part of a dupilumab study or have used, or cannot use, dupilumab due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 24, 76 and 128
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 24, 76 and 128 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP)
Secondary study objectives
Absolute change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe
Change from baseline in EoE-HSS Stage
Change from baseline in eosinophilic esophagitis (EoE-HSS) Grade
+6 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
OLE Period: Dupilumab/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
Subcutaneous injection (SC) as per protocol
Group II: PlaceboPlacebo Group1 Intervention
SC injection as per protocol
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?

SanofiLead Sponsor
2,215 Previous Clinical Trials
4,047,068 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,229 Patients Enrolled for Eosinophilic Esophagitis
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,760 Total Patients Enrolled
10 Trials studying Eosinophilic Esophagitis
1,321 Patients Enrolled for Eosinophilic Esophagitis
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,594 Total Patients Enrolled
1 Trials studying Eosinophilic Esophagitis
150 Patients Enrolled for Eosinophilic Esophagitis
~29 spots leftby Dec 2025
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