Clinical Research Directory

Inebilizumab for the Treatment of Patients With Type 1 Autoimmune Pancreatitis

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.

A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence

Autoimmune pancreatitis (AIP) is an autoimmune disease with low incidence rate and involving the pancreas. In China, type I AIP is predominant. Glucocorticoids (GC) have a significant therapeutic effect. Even though a consensus has been reached on the effective initial GC treatment dose, type I AIP is prone to recurrence after GC induction and maintenance therapy. Currently, there is no consensus on how to reduce the disease recurrence rate in high-risk type I AIP patients. Multiple studies have shown that immunosuppressants (IM) combined with GC can effectively reduce the disease recurrence rate in IgG4 RD patients, including azathioprine, mycophenolate mofetil (MMF), etc. Among them, the incidence of adverse reactions in MMF is relatively low. As a special type of IgG4-RD, there is currently no prospective study evaluating the efficacy and safety of GC combined with MMF treatment in high-risk recurrent type I AIP patients. The smooth implementation of this project can provide new treatment ideas and evidence-based medicine for reducing the recurrence rate of high-risk type I AIP.