Dupilumab Therapy for EGIDs

NCT07257835 | Recruiting FDA Drug FDA Device

• 1 other identifier: Dupilumab in EGIDs
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eosinophilic Gastrointestinal Disorders (EGIDs)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relative Change of Peak Eosinophil Counts in the Stomach

  week12，week26，week52

Other Outcomes (1)

• Adverse event

  within one year

Study Arms (1)

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

Drug: Dupilumab - Standard Dose; Device: subcutaneous injection

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

201102

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample, stool samples and biopsy samples during endoscopy

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

dupilumab; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Ying Huang

CONTACT

021-64931727; yhuang815@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of gastroenterology department

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)