Dupilumab Therapy for EGIDs
- Sponsor
- Children's Hospital of Fudan University
- Study ID
- NCT07257835
- Status
- Recruiting
Conditions
- Eosinophilic Gastrointestinal Disorders (EGIDs)
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab - Standard Dose — DRUGDose: 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 — DEVICEDose: 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.
Study Details
This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.
Key Dates
- Start date
- Jan 1, 2025
- Status verified
- Nov 2025
- Primary completion
- Jan 1, 2027
- Completion
- Dec 1, 2027
Study Design
- Enrollment
- 20 participants (estimated)
Arms
- Arm: The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump
Primary Outcome Measure
Endoscopic response rate [ Time Frame: week12, week26, week52 ]
Central Contacts
- Ying Huang021-64931727
Related Studies
- OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the AgesRecruiting · Children's Hospital Medical Center, Cincinnati · Phoenix, Arizona