[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649581":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":45,"centralContacts":50,"locations":45,"responsibleParty":58,"collaborators":45,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":45,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":45,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":45,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":45},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14,19,22,26,30,33,36],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A- DDY391 dose level 1","EXPERIMENTAL","DDY391 dose level 1",[13],"Drug: DDY391",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A-Placebo","Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.",[13,18],"Drug: Placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"Part B- DDY391 dose level 1",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part B- DDY391 dose level 2","DDY391 dose level 2",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part B- DDY391 dose level 3","DDY391 dose level 3",[13],{"label":31,"type":10,"description":16,"interventionNames":32},"Part B- Placebo",[13,18],{"label":34,"type":10,"description":11,"interventionNames":35},"Part C- DDY391 dose level 1",[13],{"label":37,"type":10,"description":16,"interventionNames":38},"Part C- Placebo",[13,18],[40,46],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","DDY391","DDY391 dose level 1\n\nDDY391 dose level 2\n\nDDY391 dose level 3",[9,15,20,23,27,31,34,37],null,{"type":41,"name":47,"description":48,"armGroupLabels":49,"otherNames":45},"Placebo","Matching Placebo",[15,31,37],[51,56],{"name":52,"role":53,"phone":54,"phoneExt":45,"email":55},"Novartis Pharmaceuticals","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":52,"role":53,"phone":57,"phoneExt":45,"email":45},"+41613241111",{"type":59,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100649581","phase-2-a-phase-2ab-study-to-assess-the-efficacy-safety-and-tolerability-of-ddy391-in-participants-with-sjgrens-disease-100649581",false,"NCT07737743","A Phase 2a\u002Fb Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a\u002Fb Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease","Key Inclusion Criteria:\n\n• Participants must have a diagnosis of SjD according to the ACR\u002FEULAR 2016 classification criteria at screening:\n\n\\- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro\u002FSSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD.\n\nKey Exclusion Criteria:\n\n* Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.\n* Exclusion based on medications being used for SjD:\n\n  * Participants taking \\> 400 mg\u002Fday hydroxychloroquine are excluded. Participants taking ≤400 mg\u002Fday hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.\n  * Participants taking \\> 400 mg\u002Fday hydroxychloroquine are excluded. Participants on ≤ 400 mg\u002Fday of hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.\n* Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous (i.v.) or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A, or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17).\n* Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to screening.\n* Any viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infection.\n* History of malignancy of any organ system (other than localized non melanoma carcinoma of the skin or in situ cervical cancer) within the last five years of randomization or any malignancy not in remission.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","100 Years",{"count":71,"type":72},344,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.",[78],"Sjögren's Disease",[78,80,81],"ESSDAI","ESSPRI","NOT_YET_RECRUITING","2026-07-27",{"date":85,"type":86},"2026-07-30","ACTUAL",{"date":88,"type":72},"2026-08-27",{"date":90,"type":72},"2029-03-19",{"name":52,"class":6}]