Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07862075
PHASE4

Inebilizumab for the Treatment of Patients With Type 1 Autoimmune Pancreatitis

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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

DRUG

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