[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656183":3},{"organization":4,"outcomesModule":7,"designInfo":98,"detailedDescription":25,"studyPopulation":25,"armGroups":109,"interventions":120,"overallOfficials":127,"centralContacts":131,"locations":25,"responsibleParty":140,"collaborators":25,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":25,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":25,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":25,"overallStatus":161,"whyStopped":25,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":25},{"fullName":5,"class":6},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in the Patients with EULAR Sjogren's Syn drome Patient Reported Index (ESSPRI) score at Week 24","Patient-reported assessment of dryness, fatigue, and pain, each scored from 0 to 10. The total ESSPRI score is calculated as the mean of the three domain scores and ranges from 0 to 10, with higher scores indicating worse symptoms.","up to week 24",[14,17,20,23,26,29,31,33,35,37,39,41,43,45,47,49,51,53,55,57,59,61,63,65,67,70,72,74,76,78,80,82,84,86,88,90,92,94,96],{"measure":15,"description":11,"timeFrame":16},"ESSPRI total score","up to week 32",{"measure":18,"description":19,"timeFrame":16},"Subjective symptom score of Sjogren's disease","Each symptom is scored daily on a numerical scale, with higher scores indicating worse symptoms.",{"measure":21,"description":22,"timeFrame":16},"EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score","Symptoms are evaluated across 12 organ\u002Fsystem domains using a 4-point scale (0 = no activity to 3 = severe activity). Each domain score is weighted according to its clinical importance, and the weighted scores are summed to yield a total score ranging from 0 to 123, with higher scores indicating greater disease activity.",{"measure":24,"description":25,"timeFrame":16},"Joint counts",null,{"measure":27,"description":28,"timeFrame":16},"Physician's Global Assessment (PGA) score","Evaluated by physician on a numerical scale. Higher scores indicate worse symptoms.",{"measure":30,"description":25,"timeFrame":12},"Stimulated salivary secretion rate",{"measure":32,"description":25,"timeFrame":12},"Unstimulated salivary secretion rate",{"measure":34,"description":25,"timeFrame":12},"Tear secretion rate",{"measure":36,"description":25,"timeFrame":16},"Adverse events and adverse reactions",{"measure":38,"description":25,"timeFrame":16},"Number of participants with abnormal laboratory tests (hematology)",{"measure":40,"description":25,"timeFrame":12},"12-lead electrocardiogram (Heart rate)",{"measure":42,"description":25,"timeFrame":12},"Number of participants with abnormal Chest X-ray tests",{"measure":44,"description":25,"timeFrame":16},"Body Weight",{"measure":46,"description":25,"timeFrame":16},"Number of participants with abnormal laboratory tests (Immunological test)",{"measure":48,"description":25,"timeFrame":12},"Rate of PD-1\u002FCD19 occupancy",{"measure":50,"description":25,"timeFrame":16},"Serum CXCL13 concentration",{"measure":52,"description":25,"timeFrame":16},"T-cell markers (immunophenotyping)",{"measure":54,"description":25,"timeFrame":16},"Anti-SS-A\u002FRo antibody titer",{"measure":56,"description":25,"timeFrame":16},"Plasma ONO-4915 concentration",{"measure":58,"description":25,"timeFrame":12},"Number of Participants with anti-ONO-4915 antibody",{"measure":60,"description":25,"timeFrame":16},"Anti-SS-B\u002FLa antibody titer",{"measure":62,"description":25,"timeFrame":16},"Anti-centromere antibody titer",{"measure":64,"description":25,"timeFrame":16},"Antinuclear antibody titer",{"measure":66,"description":25,"timeFrame":16},"Concentration of Rheumatoid factor",{"measure":68,"description":69,"timeFrame":16},"ESSPRI domain scores","Scores for the dryness, pain, and fatigue symptoms comprising the ESSPRI. Higher scores indicate worse symptom severity.",{"measure":71,"description":25,"timeFrame":16},"ESSPRI responder rate",{"measure":73,"description":25,"timeFrame":16},"Serum BAFF concentration",{"measure":75,"description":25,"timeFrame":16},"B-cell markers (immunophenotyping)",{"measure":77,"description":25,"timeFrame":16},"Number of participants with abnormal laboratory tests (blood biochemistry)",{"measure":79,"description":25,"timeFrame":16},"Number of participants with abnormal laboratory tests (urinalysis)",{"measure":81,"description":25,"timeFrame":16},"Number of participants with abnormal laboratory tests (coagulation tests)",{"measure":83,"description":25,"timeFrame":12},"12-lead electrocardiogram (PR interval)",{"measure":85,"description":25,"timeFrame":12},"12-lead electrocardiogram (RR interval)",{"measure":87,"description":25,"timeFrame":12},"12-lead electrocardiogram (QRS duration)",{"measure":89,"description":25,"timeFrame":12},"12-lead electrocardiogram (QT interval)",{"measure":91,"description":25,"timeFrame":12},"12-lead electrocardiogram (QTcF Interval)",{"measure":93,"description":25,"timeFrame":16},"Blood Pressure",{"measure":95,"description":25,"timeFrame":16},"Pulse Rate",{"measure":97,"description":25,"timeFrame":16},"Body Temperature",{"allocation":99,"interventionModel":100,"interventionModelDescription":25,"primaryPurpose":101,"observationalModel":25,"timePerspective":25,"maskingInfo":102},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":103,"maskingDescription":25,"whoMasked":104},"QUADRUPLE",[105,106,107,108],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[110,115],{"label":111,"type":112,"description":25,"interventionNames":113},"ONO-4915","EXPERIMENTAL",[114],"Drug: ONO-4915",{"label":116,"type":117,"description":25,"interventionNames":118},"Placebo","PLACEBO_COMPARATOR",[119],"Drug: Placebo",[121,125],{"type":122,"name":111,"description":123,"armGroupLabels":124,"otherNames":25},"DRUG","Subcutaneous administration",[111],{"type":122,"name":116,"description":123,"armGroupLabels":126,"otherNames":25},[116],[128],{"name":129,"affiliation":5,"role":130},"Project Leader","STUDY_DIRECTOR",[132,137],{"name":133,"role":134,"phone":135,"phoneExt":25,"email":136},"North America Clinical Trial Support Desk","CONTACT","+18665877745(Toll-Free)","clinical_trial@ono-pharma.com",{"name":138,"role":134,"phone":139,"phoneExt":25,"email":136},"International Clinical Trial Support Desk","+17162141777(Standard)",{"type":141,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100656183","phase-2-ono-4915-in-patients-with-primary-sjogrens-disease-100656183",false,"NCT07823790","ONO-4915 in Patients With Primary Sjogren's Disease","A Phase II Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study in Patients With Primary Sjogren's Disease to Evaluate the Efficacy and Safety of Subcutaneously Administered ONO-4915","Inclusion Criteria:\n\n* Age (at the time of informed consent): \\>=18 and \\\u003C75 years\n* Patients who meet the criteria for primary Sjogren's disease defined by the 2016 ACR\u002FEULAR Classification Criteria for Primary Sjogren's Syndrome\n* Patients with positive anti-SS-A\u002FRo antibody in the screening period\n* Patients with ESSPRI score of \\>=5 and dry symptom score of \\>=5 in the screening period\n* Patients with stimulated salivary secretion rate of \\>=0.1 mL\u002Fmin by the Saxon test in the screening period.\n* Patients diagnosed with primary Sjogren's disease within 10 years\n\nExclusion Criteria:\n\n* Patients with other concurrent autoimmune diseases\n* Patients who may overlap with the clinical symptoms of primary Sjogren's disease or interfere with the evaluation of the clinical symptoms\n* Patients with any disease that may interfere with the evaluation of dry symptoms of primary Sjogren's disease\n* Patients with any disease that may interfere with the evaluation of pain of primary Sjogren's disease\n* Patients with severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease unrelated to the primary disease\n* Patients with current malignancy or history of malignancy within 5 years before the start of screening\n* Patients with active infection","ALL","18 Years","74 Years",{"count":153,"type":154},60,"ESTIMATED","INTERVENTIONAL",[157],"PHASE2","To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease",[160],"Sjogren's Disease","NOT_YET_RECRUITING","2026-09-13",{"date":164,"type":165},"2026-09-16","ACTUAL",{"date":167,"type":154},"2026-10",{"date":169,"type":154},"2029-02",{"name":5,"class":6}]