[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648347":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":103,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":32,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":133,"whyStopped":32,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lenalidomide Arm","EXPERIMENTAL","Participants will receive lenalidomide 5 mg orally once daily for 52 weeks as maintenance therapy. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period. Lenalidomide will be administered in addition to background glucocorticoid management.",[13],"Drug: Lenalidomide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Arm","PLACEBO_COMPARATOR","Participants will receive matching placebo orally once daily for 52 weeks as maintenance therapy. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period. The placebo will be identical in appearance, packaging, labeling, and administration procedures to lenalidomide.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lenalidomide","Lenalidomide will be administered orally at a dose of 5 mg once daily for 52 weeks as maintenance therapy in participants with IgG4-related disease in sustained clinical remission. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period.",[9],[27],"Len",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Matching placebo will be administered orally once daily for 52 weeks as maintenance therapy. The placebo will be identical to lenalidomide in appearance, packaging, labeling, and administration procedures. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Jian Zhu, MD, PhD","The First Medical Center of Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Yufei Guo, MD","CONTACT","+86 010-55499314","dt_guoyf0412@outlook.com",{"name":45,"role":41,"phone":42,"phoneExt":32,"email":46},"Yiwen Wang, MD","yiwenvera@163.com",[48,67,85],{"facility":36,"status":32,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Beijing","Beijing Municipality","100853","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61,62,63,65],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},{"name":45,"role":41,"phone":42,"phoneExt":32,"email":46},{"name":64,"role":37,"phone":32,"phoneExt":32,"email":32},"Jian Zhu, MD, Ph.D",{"name":45,"role":66,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"facility":68,"status":32,"city":69,"state":70,"zip":71,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hainan Hospital of Chinese PLA General Hospital","Sanya","Hainan","572013",{"type":55,"coordinates":73},[74,75],109.50947,18.25435,{"lat":75,"lon":74},[78,82,84],{"name":79,"role":41,"phone":80,"phoneExt":32,"email":81},"Chao Xue, MM","+86 15692537568","xuechao301hn@163.com",{"name":83,"role":66,"phone":32,"phoneExt":32,"email":32},"Xiaofei Liu, MM",{"name":79,"role":66,"phone":32,"phoneExt":32,"email":32},{"facility":86,"status":32,"city":87,"state":88,"zip":89,"country":52,"countryCode":53,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"General Hospital of Central Theater Command","Wuhan","Hubei","430070",{"type":55,"coordinates":91},[92,93],114.26667,30.58333,{"lat":93,"lon":92},[96,100,102],{"name":97,"role":41,"phone":98,"phoneExt":32,"email":99},"Jiali Yu, MM","+86 15527777152","jiali_jlyu@126.com",{"name":101,"role":66,"phone":32,"phoneExt":32,"email":32},"Lifeng Chen, MD",{"name":97,"role":66,"phone":32,"phoneExt":32,"email":32},{"type":37,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Jian Zhu","Professor and Chief Physician",[107],{"name":108,"class":109},"Beijing SL Pharmaceutical Co., Ltd.","UNKNOWN","100648347","phase-3-efficacy-and-safety-of-lenalidomide-in-patients-with-igg4-related-disease-100648347",false,"NCT07719543","Efficacy and Safety of Lenalidomide in Patients With IgG4-Related Disease","A Phase III Multicenter Randomized Double-Blind Placebo-Controlled Study Evaluating the Efficacy and Safety of Lenalidomide in Patients With IgG4-Related Disease","LENITY","Inclusion Criteria:\n\n1. Adults aged 18 to 75 years at the time of screening.\n2. Diagnosis of IgG4-related disease according to the 2019 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) classification criteria.\n3. Patients with IgG4-related disease who have achieved sustained clinical remission following glucocorticoid therapy.\n4. No documented IgG4-related disease relapse within the previous 12 months before screening.\n5. IgG4-related disease Responder Index (IgG4-RD RI) score of 0 at screening.\n6. Receiving stable low-dose glucocorticoid therapy with prednisone-equivalent dose ≤7.5 mg\u002Fday for at least 6 months before randomization.\n7. Ability to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Active IgG4-related disease requiring induction therapy or escalation of immunosuppressive treatment at screening.\n2. Previous treatment with lenalidomide or known hypersensitivity to lenalidomide or related compounds.\n3. Requirement for prohibited concomitant medications during the study period.\n4. Significant uncontrolled infection or active severe infection.\n5. Clinically significant hematologic abnormalities, including severe neutropenia or thrombocytopenia.\n6. Significant hepatic or renal dysfunction that may affect study participation or drug safety evaluation.\n7. History of thromboembolic events or conditions associated with unacceptable thrombotic risk according to investigator assessment.\n8. Pregnancy, breastfeeding, or unwillingness to use effective contraception when applicable.\n9. Malignancy or other severe medical conditions that may interfere with study participation or outcome assessment.\n10. Any condition that, in the investigator's opinion, may compromise participant safety or affect the reliability of study results.","ALL","18 Years","75 Years",{"count":122,"type":123},146,"ESTIMATED","INTERVENTIONAL",[126],"PHASE3","Immunoglobulin G4-related disease (IgG4-RD) is a chronic immune-mediated disorder characterized by inflammation, fibrosis, and involvement of multiple organs. Although glucocorticoids can effectively induce remission, many patients experience disease relapse after glucocorticoid tapering or discontinuation, and long-term glucocorticoid exposure may cause significant adverse effects. Therefore, new maintenance treatment strategies are needed to reduce relapse risk and minimize glucocorticoid-related toxicity.\n\nThis study is designed to evaluate the efficacy and safety of lenalidomide as a maintenance therapy in patients with stable IgG4-RD. This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.\n\nEligible participants will be adults with IgG4-RD who meet the 2019 ACR\u002FEULAR IgG4-RD classification criteria and are in a stable disease state. Participants will be randomly assigned in a 1:1 ratio to receive either lenalidomide or matching placebo for 52 weeks. All participants will receive standardized glucocorticoid tapering according to the study protocol.\n\nThe primary objective of this study is to determine whether lenalidomide can reduce the risk of IgG4-RD relapse compared with placebo. The primary outcome is the proportion of participants experiencing disease relapse within 52 weeks after randomization.\n\nSecondary objectives include evaluation of time to relapse, maintenance of remission, changes in disease activity, quality of life, and safety outcomes. Exploratory assessments will investigate changes in immunological biomarkers, peripheral blood immune profiles, transcriptomic characteristics, and gut microbiota.\n\nThis study aims to provide clinical evidence for a new maintenance treatment approach for patients with IgG4-RD and potentially reduce disease recurrence and glucocorticoid exposure.",[129],"Immunoglobulin G4-Related Disease",[131,23,132],"IgG4-related disease","Maintenance therapy","NOT_YET_RECRUITING","2026-07-18",{"date":136,"type":137},"2026-07-22","ACTUAL",{"date":139,"type":123},"2026-08-01",{"date":141,"type":123},"2030-12-31",{"name":5,"class":6},3]