Dupilumab Therapy for EGIDs

Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children

This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.

Study Overview

• Status: Recruiting
• Conditions: Eosinophilic Gastrointestinal Disorders (EGIDs)
• Intervention / Treatment: Drug: Dupilumab - Standard Dose; Device: subcutaneous injection

Detailed Description

Eosinophilic Gastrointestinal Disorders (EGIDs) are chronic inflammatory diseases caused by extensive infiltration of eosinophils in the gastrointestinal tract. Treatment requires long-term dietary avoidance, long-term oral administration of high-dose omeprazole, as well as hormones and immunosuppressants, but the results are unsatisfactory and the side effects are significant. Dupilumab is a fully human monoclonal antibody (IgG4 type) that can specifically bind to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes to inhibit the signal transduction of IL-4 and IL-13. Current studies have shown that subcutaneous treatment with dupilumab for eosinophilic esophagitis has significant efficacy. In recent years, this drug has been reported to be used for various forms of gastrointestinal diseases such as eosinophilic gastritis, duodenitis, etc., with remarkable efficacy. In recent years, there has been an increasing number of children with refractory eosinophilic gastrointestinal diseases, which can easily cause repeated large ulcers, perforation, and stenosis in the gastrointestinal tract, requiring surgical intervention. This disease seriously affects the growth and development of children and urgently requires better treatment options. This study aims to evaluate the efficacy and tolerance of dupilumab in children with refractory eosinophilic gastrointestinal diseases.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Ying Huang; Phone Number: 021-64931727; Email: yhuang815@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • 201102
    • Contact: Zhi-heng Huang; Phone Number: 021-64931727; Email: yhuang815@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children diagnosed with refractory eosinophilic gastrointestinal disorders who were seen at the Children's hospital of Fudan university who met the inclusion and exclusion criteria would be enrolled in this study.

Description

Inclusion Criteria:

• Clinical diagnosis of Refractory Peptic Ulcers
• with Refractory Eosinophilic Gastrointestinal Disorders

Exclusion Criteria:

• with Active Helicobacter pylori infection at present.
• with Inflammatory bowel disease
• with Parasite infection
• with Cancer

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump

Drug: Dupilumab - Standard Dose; Dose: For patients with weight ≥ 15kg but < 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but < 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.; Device: subcutaneous injection; Dose: For patients with weight ≥ 15kg but < 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but < 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic response rate	The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%.	week12, week26, week52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Change of Peak Eosinophil Counts in the Stomach	We will determine the relative change from baseline in the peak eosinophil count in the five high-power fields (HPFs) with the highest eosinophil density in the antrum and/or body of the stomach after intervention.	week12，week26，week52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	The rate of the potential adverse events were monitored during the intervention.	within one year

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; dupilumab; Injections, Subcutaneous
• Other Study ID Numbers: Dupilumab in EGIDs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes