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Inebilizumab for the Treatment of Patients With Type 1 Autoimmune Pancreatitis
Sponsor: Ruijin Hospital
Summary
Autoimmune pancreatitis (AIP) is an immune-related inflammatory disease of the pancreas. Relapse can occur after treatment, and long-term treatment with glucocorticoids and conventional immunosuppressants can cause significant side effects. This multicenter, single-arm, open-label study aims to evaluate the efficacy and safety of inebilizumab in patients with AIP. Inebilizumab targets CD19 and reduces B cells, including plasmablasts. The study plans to enroll 50 patients with confirmed AIP, including both newly diagnosed patients and patients with relapsing disease. All eligible participants will receive inebilizumab and follow a standardized glucocorticoid dose-reduction regimen. The primary objective is to assess whether inebilizumab can reduce the relapse rate within 32 weeks. Secondary objectives are to assess its effects on glucocorticoid use, serum IgG4 levels, B-cell counts, and other immune cells. Peripheral blood samples and lymph node samples will be collected for exploratory mechanistic analyses to characterize circulating and tissue immune-cell populations and blood-based biomarkers during treatment and follow-up.
Official title: Inebilizumab for the Treatment of Patients With Relapsing Type 1 Autoimmune Pancreatitis: A Multicenter, Single-Arm, Open-Label Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-10-01
Completion Date
2028-09-30
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Inebilizumab
All patients with type 1 AIP received a standardised glucocorticoid tapering regimen: 30 mg/day for one month, followed by a reduction of one tablet every two weeks to 20 mg/day. Treatment with inelizumab was initiated as follows: Day 1: intravenous infusion of inelizumab 300 mg; Day 15: intravenous infusion of inelizumab 300 mg. Maintenance phase: Thereafter, one infusion of 300 mg every 24 weeks (6 months) until the end of the study. Peripheral blood and lymph node sampling is planned at specified study visits and at disease relapse for exploratory mechanistic analyses, as detailed in the study description.
Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai, China