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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 160
Awards & highlights

EoE KIDS Trial 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.Check my eligibility
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.See study design
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.

EoE KIDS Trial Eligibility Criteria

Inclusion Criteria

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

EoE KIDS Trial 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
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab

EoE KIDS 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
~12230
Matching Placebo
2012
Completed Phase 4
~10710

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
615 Previous Clinical Trials
379,745 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
812 Patients Enrolled for Eosinophilic Esophagitis
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,378 Total Patients Enrolled
5 Trials studying Eosinophilic Esophagitis
741 Patients Enrolled for Eosinophilic Esophagitis
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
259 Previous Clinical Trials
250,942 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

Frequently Asked Questions

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

How is Dupilumab utilized in medical treatment?

"Dupilumab is an effective corticosteroid-free treatment for dermatitis, atopic eczema, and eosinophilic conditions."

Answered by AI

Is this a brand new clinical trial?

"Dupilumab has been the focus of 52 different clinical trials, with 455 cities and 43 countries represented. The first study was completed in 2015 by Sanofi. This initial Phase 3 drug approval stage involved 880 patients. In the 5 years since completion, 134 studies have been conducted."

Answered by AI

Are there any life-threatening risks associated with Dupilumab?

"Dupilumab has undergone Phase 3 trials, meaning that there is available data which supports both its efficacy and safety. Our team rates it a 3 on our safety scale."

Answered by AI

Are there any other research articles that explore Dupilumab's effects?

"In 2015, the first Dupilumab clinical trial was completed at Regeneron Investigational Site. As of now, a total of 134 have been completed with 52 more currently underway. Many of theseactive trials are based in Chapel Hill, North carolina."

Answered by AI

Could I take part in this experiment?

"We are looking for 102 children aged 1-11 that have been diagnosed with eosinophilic esophagitis. Most importantly, these patients must have a documented diagnosis of EoE as well as key baseline endoscopic biopsies that show intraepithelial eosinophilic infiltration."

Answered by AI

Is patient enrollment still open for this research project?

"From what is detailed on clinicaltrials.gov, this research study is not currently looking for new participants as it has already finished recruiting. The listing was first posted on September 1st 2020 and updated last on September 15th 2022. Even though this specific trial isn't taking any more volunteers, there are 104 other studies that are."

Answered by AI

How many individuals are participating in this research project?

"Unfortunately, this particular clinical trial is not actively looking for patients right now. The study was first posted on September 1st 2020 and was updated as recently as September 15th 2022. There are other options though! Currently, there are 52 trials searching for candidates with eosinophilic esophagitis and another 52 studies recruiting patients for Dupilumab research."

Answered by AI

Are any minors part of this research study?

"According to the study's guidelines, any child aged 1-11 years old can participate."

Answered by AI

Who else is applying?

What state do they live in?
New York
Ontario
What site did they apply to?
Regeneron Study Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Regeneron Study Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
2020. "Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04394351.
All > Eosinophilic Esophagitis
~22 spots leftby Apr 2025
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