[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-aip\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-aip":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100659265","phase-4-inebilizumab-for-the-treatment-of-patients-with-type-1-autoimmune-pancreatitis-100659265",false,"NCT07862075","Inebilizumab for the Treatment of Patients With Type 1 Autoimmune Pancreatitis","Inebilizumab for the Treatment of Patients With Relapsing Type 1 Autoimmune Pancreatitis: A Multicenter, Single-Arm, Open-Label Study","Inclusion Criteria:\n\n1. A signed and dated informed consent form;\n2. A commitment to adhere to the study protocol and to cooperate throughout the entire study;\n3. Aged 18 years or over, regardless of gender;\n4. Diagnosed with Type I AIP;\n5. Indications for treatment: (1) For symptomatic participants, evidence of pancreatic involvement (e.g. obstructive jaundice, abdominal pain, lower back pain) and extra-pancreatic organ involvement (e.g. jaundice caused by bile duct stricture); (2) Asymptomatic participants with subclinical AIP that may progress to severe, irreversible damage to vital organs (e.g. persistent pancreatic mass, abnormal liver function accompanied by proximal IgG4-related sclerosing cholangitis);\n6. Be able to adhere to and cooperate with study interventions, such as taking oral medication;\n7. If a woman of childbearing potential, she must have used contraception for at least one month prior to screening and undertake to use contraception throughout the study period and for a specified period following the study's conclusion;\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from this study:\n\n1. Women who are trying to conceive, are pregnant or are breastfeeding;\n2. Those who are unable or refuse to sign the informed consent form;\n3. History of mental illness;\n4. Allergy to the study intervention;\n5. Concurrent malignant tumours;\n6. Infectious diseases such as active hepatitis or tuberculosis;\n7. Concurrent uncontrolled underlying conditions, such as severe heart failure or respiratory failure.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","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.\n\nThis 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.\n\nThe 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.\n\nThe 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.\n\nPeripheral 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.",[26],"Type 1 AIP",[26,28,29,30],"Inebilizumab","Anti-CD19","Treatment","RECRUITING","2026-10-01",{"date":34,"type":35},"2026-10-07","ACTUAL",{"date":37,"type":35},"2025-10-01",{"date":39,"type":20},"2028-09-30",{"name":41,"class":42},"Ruijin Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100552101","phase-4-a-trial-on-the-recurrence-free-survival-rate-of-type-i-aip-with-high-risk-of-recurrence-100552101","NCT06468709","A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence","A Multicenter, Prospective, Randomized Controlled Trial on the Remission Rate of Type I AIP With High-risk of Recurrence Patients Receiving Glucocorticoid Maintenance Therapy\u002FGlucocorticoid Combined With Mycophenolate Mofetil Maintenance Therapy","AIP；MMF","Inclusion Criteria:\n\n1. Signed informed consent form with date;\n2. Promise to comply with research procedures and cooperate with the implementation of the entire process research;\n3. Age 18 and above, regardless of gender;\n4. Confirmed as type I AIP and high-risk for recurrence, including the following characteristics: IgG4\\>4 times the upper limit of normal value before treatment; The serum IgG4 level remained high after GC treatment; Pancreatic diffuse enlargement; IgG4-SC with proximal bile duct involvement; Involvement of extrapancreatic organs;\n5. Indications for treatment, (1) symptomatic individuals may experience pancreatic involvement (such as obstructive jaundice, abdominal pain, lower back pain, etc.) and extrapancreatic organ involvement (such as jaundice caused by bile duct stenosis, etc.); (2) Asymptomatic individuals, who may develop subclinical AIP (persistent pancreatic mass, liver dysfunction with proximal IgG4 associated sclerosing cholangitis) with severe and irreversible damage to important organs;\n6. Able to persist and cooperate with research interventions, such as oral medication;\n7. If it is a woman in the reproductive period, contraception should be used for at least one month before screening, and a commitment should be made to use contraception throughout the entire study period and continue until the specified time after the end of the study\n\nExclusion Criteria:\n\n1. Pregnant\u002Flactating women; Inability or refusal to sign informed consent form;\n2. History of mental illness;\n3. Allergy to research interventions;\n4. With malignant tumors;\n5. Active hepatitis\u002Ftuberculosis and other infectious diseases;\n6. With underlying diseases that are difficult to control, such as severe heart failure, respiratory failure, etc;\n7. Within 3 months, use of glucocorticoids or immunosuppressants due to other illnesses",{"count":53,"type":20},86,[23],"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.",[26],[26,58,59,60],"Recurrence","Glucocorticoids","MMF",{"date":62,"type":35},"2026-10-06",{"date":64,"type":35},"2024-06-30",{"date":66,"type":20},"2029-09-30",{"name":41,"class":42}]