Inebilizumab for the Treatment of Patients With Type 1 Autoimmune Pancreatitis
ConditionType 1 AIP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A signed and dated informed consent form;
A commitment to adhere to the study protocol and to cooperate throughout the entire study;
Aged 18 years or over, regardless of gender;
Diagnosed with Type I AIP;
Disqualifiers
Women who are trying to conceive, are pregnant or are breastfeeding;
Those who are unable or refuse to sign the informed consent form;
History of mental illness;
Allergy to the study intervention;
Trial design
Design model
Single group
Treatments tested in this trial
Inebilizumab
DrugAll 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Inebilizumab TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence rate within 6 months
The proportion of participants with type 1 autoimmune pancreatitis who experience disease relapse within 6 months. Disease relapse will be assessed using clinical symptoms and signs, laboratory findings, including serum IgG4, IgG, liver function, erythrocyte sedimentation rate, complete blood count, and B-cell counts, and contrast-enhanced pancreatic MRI.
Time frame
6 monthsSecondary outcomes
1
Daily Glucocorticoid Dose
The daily dose of glucocorticoids taken by each participant will be recorded in mg/day at baseline and at scheduled follow-up visits. Daily doses will be summarized separately for each assessment time point.
Time frame
Baseline through 6 months2
Serum IgG4 level
Serum IgG4 level will be measured at baseline and at scheduled follow-up visits. Measured level will be summarized separately for each assessment time point.
Time frame
Baseline through 6 months3
Peripheral Blood B-Cell Count
B-cell counts in peripheral blood will be measured at baseline and at scheduled follow-up visits. Measured counts will be summarized separately for each assessment time point.
Time frame
Baseline through 6 months4
Other immune cells in Peripheral Blood
The count of other immune cells in peripheral blood will be measured at baseline and at scheduled follow-up visits. Measured counts will be summarized separately for each assessment time point.
Time frame
Baseline through 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
Tianjin Medical University General Hospital
Collaborator
The First Affiliated Hospital of University of Science and Technology of China
Collaborator
First Hospital of China Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
The First People's Hospital of Yunnan
Collaborator
Zhongshan Hospital Affiliated to Xiamen University
Collaborator
Second Affiliated Hospital of Soochow University
Collaborator
Zunyi Medical College
Collaborator
Shengjing Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Collaborator
The Third Affiliated Hospital of Soochow University
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Source ClinicalTrials.gov