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

NCT07112378 | Recruiting Phase 3 FDA Drug

• 1 other identifier: R668-EE-2423
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

Brief 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)

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

Type 2 Inflammatory; Allergic/immune-mediated; Esophageal dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent Serious Adverse Events (SAEs)

  Up to 24 Weeks

Secondary Outcomes (11)

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

  Up to 24 Weeks

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

  Up to 24 Weeks

• Incidence of TEAEs

  Up to 24 Weeks

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

  At Week 24

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

  At Week 24

Study Arms (2)

Dosing Regimen 1

EXPERIMENTAL

Drug: dupilumab

Dosing Regimen 2

EXPERIMENTAL

Drug: dupilumab

Interventions

dupilumab DRUG

Administered as defined in the protocol

Also known as: DUPIXENT®, REGN668, SAR231893

Dosing Regimen 1; Dosing Regimen 2

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged ≥6 months and weighing ≥5 kg and \<15 kg at screening with active EoE
• 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
• 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

You may not qualify if:

• Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
• 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
• Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
• Active Helicobacter pylori infection
• History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
• Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
• 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
• Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (8)

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

GI Care for Kids LLC

Atlanta, Georgia, 30342, 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

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

MeSH Terms

Conditions

Eosinophilic Esophagitis; Esophageal Diseases

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Esophagitis; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): June 19, 2028
• Study Completion (Estimated): October 9, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (8)