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NCT Number: NCT07257835

Dupilumab Therapy for EGIDs

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dupilumab - Standard Dose

Drug

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.

subcutaneous injection

Device

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.

Primary outcomes

  1. Endoscopic response rate

    Time frame: week12, week26, week52

    The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%.

Secondary outcomes

  1. Relative Change of Peak Eosinophil Counts in the Stomach

    Time frame: week12,week26,week52

    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.

Other outcomes

  1. Adverse event

    Time frame: within one year

    The rate of the potential adverse events were monitored during the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Huang

CONTACT

[email protected]

021-64931727

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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