NCT07257835

Dupilumab Therapy for EGIDs

Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Eosinophilic Gastrointestinal Disorders (EGIDs)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2027-12-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study
• FDA-regulated device study