Dupilumab Therapy for EGIDs

Fudan University

Status: Enrolling

Conditions: Eosinophilic Gastrointestinal Disorders (EGIDs)

Treatments: Device: subcutaneous injection; Drug: Dupilumab - Standard Dose

Study type: Observational

Funder types: Other

Identifiers

NCT07257835

Dupilumab in EGIDs

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

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

Treatment:

Drug: Dupilumab - Standard Dose

Device: subcutaneous injection