Dupilumab Therapy for EGIDs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab - Standard Dose, subcutaneous injection.
- Who it may be relevant to
- Registry conditions: Eosinophilic Gastrointestinal Disorders (EGIDs). Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children
Overview
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.
Interventions
- 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.
Primary outcome measures
- Endoscopic response rate [Time frame: week12, week26, week52]
Secondary outcome measures (1)
- Relative Change of Peak Eosinophil Counts in the Stomach [Time frame: week12，week26，week52]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- 201102 — Shanghai
Identifiers
NCT: NCT07257835 · Dupilumab in EGIDs