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Monoclonal Antibodies

Dupilumab for Eosinophilic Esophagitis (EoE KIDS Trial)

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
A documented diagnosis of eosinophilic esophagitis (EoE)
Be younger than 18 years old
Must not have
Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
Patients who are ≥12 years old, weigh ≥40 kg (or minimum weight for which dupilumab is approved for EoE), and dupilumab is commercially available for the treatment of EoE in their country
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 160
Awards & highlights

Summary

This trial is testing whether dupilumab is an effective treatment for pediatric patients with active eosinophilic esophagitis, compared to placebo. The secondary objectives are to evaluate the safety and tolerability of the treatment, and to study the effects of dupilumab on gene expression associated with EoE and type 2 inflammation.

Who is the study for?
This trial is for pediatric patients with active Eosinophilic Esophagitis (EoE). Participants must have a confirmed diagnosis and show specific levels of eosinophil infiltration in their esophagus. It's not for those over 12 years old who weigh more than 40 kg if Dupilumab is available commercially, or anyone with certain esophageal conditions, parasitic infections, immune disorders, or history of severe reactions to Dupilumab.
What is being tested?
The study tests the effectiveness and safety of Dupilumab compared to a placebo in treating EoE in children. The main goal is to see if there's an improvement based on biopsy results after 16 weeks. Other goals include checking how well kids tolerate the drug long-term and its effects on growth, symptoms, and inflammation markers.
What are the potential side effects?
While the trial aims to assess safety thoroughly, potential side effects may include allergic reactions at the injection site, increased risk of infection due to immune system changes caused by Dupilumab treatment. Long-term impacts on growth will also be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with eosinophilic esophagitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a narrow esophagus that can't be examined with a standard scope without dilation.
Select...
I am 12 or older, weigh at least 40 kg, and can get dupilumab for EoE where I live.
Select...
I have a history of Crohn's, ulcerative colitis, celiac disease, or esophageal surgery.
Select...
I have or might have a parasitic infection.
Select...
My body weight is either below 5 kg or above 60 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 160
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 160 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients achieving peak esophageal intraepithelial eosinophil count ≤6 eos/hpf (400×)
Secondary outcome measures
Absolute change in EoE-EREFS
Absolute change in Eosinophilic Esophagitis-Endoscopic Reference (EoE EREFS)
Absolute change in mean EoE-HSS
+35 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
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

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part C - High DoseExperimental Treatment1 Intervention
Part C consists of up to 108-week open-label extension period. All patients will receive higher exposure dupilumab subcutaneous (SC) administration at tiered dosing regimens based on body weight. No matching placebo administered in Part C.
Group II: Part B - Low DoseExperimental Treatment2 Interventions
Part B consists of a 36-week extended active treatment period. All patients to receive subcutaneous (SC) administration at tiered dosing regimens based on body weight
Group III: Part B - High DoseExperimental Treatment2 Interventions
Part B consists of a 36-week extended active treatment period. All patients to receive subcutaneous (SC) administration at tiered dosing regimens based on body weight
Group IV: Part A - Low DoseExperimental Treatment2 Interventions
Part A consists of a 16-week double-blind treatment period. Patients will be randomized to receive dupilumab or placebo subcutaneous (SC) administration at tiered dosing regimens based on body weight
Group V: Part A - High DoseExperimental Treatment2 Interventions
Part A consists of a 16-week double-blind treatment period. Patients will be randomized to receive dupilumab or placebo subcutaneous (SC) administration at tiered dosing regimens based on body weight
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960
Matching Placebo
2012
Completed Phase 4
~10710

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
637 Previous Clinical Trials
382,339 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
803 Patients Enrolled for Eosinophilic Esophagitis
SanofiIndustry Sponsor
2,173 Previous Clinical Trials
3,516,388 Total Patients Enrolled
5 Trials studying Eosinophilic Esophagitis
741 Patients Enrolled for Eosinophilic Esophagitis
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
271 Previous Clinical Trials
252,565 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
647 Patients Enrolled for Eosinophilic Esophagitis

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04394351 — Phase 3
Eosinophilic Esophagitis Research Study Groups: Part A - Low Dose, Part B - High Dose, Part B - Low Dose, Part C - High Dose, Part A - High Dose
Eosinophilic Esophagitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04394351 — Phase 3
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04394351 — Phase 3
~20 spots leftby Sep 2025
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