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RecruitingNCT07112378EoE-TOTsUpdated Sep 29, 2026

A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis

A Phase 3 interventional study of dupilumab in Eosinophilic Esophagitis (EoE), sponsored by Regeneron Pharmaceuticals. Recruiting at 13 sites in United States. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
6 Months to 6 Years
Sex
All
01

Study summary

This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.

The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
02

Conditions studied

  • Eosinophilic Esophagitis (EoE)

Keywords

  • Type 2 Inflammatory
  • Allergic/immune-mediated
  • Esophageal dysfunction
03

Who can participate

Ages eligible
6 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Pediatric patients aged ≥6 months and weighing ≥5 kg and \<15 kg at screening with active EoE
  2. History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol
  3. Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol

Key Exclusion Criteria:

  1. Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
  2. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study
  3. Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
  4. Active Helicobacter pylori infection
  5. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
  6. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
  7. History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure
  8. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Dosing Regimen 1

    Drug: dupilumab

  • Experimental
    Dosing Regimen 2

    Drug: dupilumab

Interventions

  • Drugdupilumab

    Administered as defined in the protocol

    Also known as: DUPIXENT®, REGN668, SAR231893

05

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent Serious Adverse Events (SAEs)

    Time frame: Up to 24 Weeks

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to permanent discontinuation of study treatment

    Time frame: Up to 24 Weeks

  2. Incidence of treatment-emergent Adverse Event of Special Interest (AESIs)

    Time frame: Up to 24 Weeks

  3. Incidence of TEAEs

    Time frame: Up to 24 Weeks

  4. Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high power field (eos/hpf) (400×)

    Time frame: At Week 24

  5. Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf (400×)

    Time frame: At Week 24

  6. Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

    Time frame: Baseline to Week 24

  7. Change in body weight for age percentile

    Time frame: Baseline up to Week 24

  8. Concentrations of functional dupilumab in serum

    Time frame: Baseline up to Week 24

  9. Incidence of Anti-Drug Antibody (ADA) to dupilumab

    Time frame: Up to Week 36

  10. Titer of ADA to dupilumab

    Time frame: Up to Week 36

  11. Incidence of Neutralizing Antibody (NAb) to dupilumab

    Time frame: Up to Week 36

06

Study locations

13 of 13 sites recruiting
  • Phoenix Childrens Hospital
    Phoenix, Arizona 85016, United States
    Recruiting
  • University of California San Francisco (UCSF)
    San Francisco, California 94143, United States
    Recruiting
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
    Recruiting
  • GI Care for Kids LLC
    Atlanta, Georgia 30342, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
  • Weill Cornell Medicine
    New York, New York 10065, United States
    Recruiting
  • University of North Carolina, Bioinformatics Building
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
    Recruiting
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
    Recruiting
  • University of Virginia
    Charlottesville, Virginia 22908, United States
    Recruiting
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
    Recruiting
  • Medical College of Wisconsin, Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07112378
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Aug 8, 2025
Start date
Nov 10, 2025
Primary completion
Jun 19, 2028 (estimated)
Completion
Oct 9, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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