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Inebilizumab for the Treatment of Patients With Type 1 Autoimmune Pancreatitis

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ruijin Hospital
370 trials monitored
See 13 trials at risk
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.
Trial Details
NCT Number NCT07862075
Lead Sponsor Ruijin Hospital
Collaborators: Tianjin Medical University General Hospital, The First Affiliated Hospital of University of Science and Technology of China, First Hospital of China Medical University, The First Affiliated Hospital of Nanchang University, The First People's Hospital of Yunnan, Zhongshan Hospital Affiliated to Xiamen University, Second Affiliated Hospital of Soochow University, Zunyi Medical College, Shengjing Hospital, The Affiliated Hospital of Qingdao University, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The Third Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University
Conditions Type 1 AIP
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov