[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjogren-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjogren-disease":27},{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100596103","phase-1-a-study-of-cln-978-a-subcutaneously-administered-cd19-directed-t-cell-engager-in-subjects-with-sjogrens-disease-100596103",false,"NCT07041099","A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease","A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease","Inclusion\n\n* Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR \u002F ACR Classification Criteria for SjD at Screening.\n* Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.\n* Laboratory parameters including the following:\n\n  * Absolute lymphocyte count (ALC) ≥0.5 × 10\\^9\u002FL\n  * Peripheral CD19+ B cell count ≥25 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥1.0 × 10\\^9\u002FL\n  * Hemoglobin (Hgb) ≥8 g\u002FdL\n  * Platelet count ≥75 × 10\\^9\u002FL\n  * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN\n  * Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL\u002Fmin\u002F1.73 m2\n\nExclusion\n\n* Concomitant rheumatological autoimmune disease\n* Considered at high risk for thrombosis\n* Rapidly progressive glomerulonephritis and\u002For urine protein\u002Fcreatinine \\>3 mg\u002Fmg (339 mg\u002Fmmol).\n* Active, severe central nervous system manifestations of SjD.\n* History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results.\n* Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.\n* Primary immunodeficiency or history of recurrent infections.\n* History of splenectomy.\n* Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period.\n* Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1.\n* Active or latent tuberculosis (TB)","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.",[26,27,28],"Sjögren","Sjogren Disease","Sjogren's Syndrome",[30],"CLN-978","RECRUITING","2026-03-20",{"date":34,"type":35},"2026-03-23","ACTUAL",{"date":37,"type":35},"2025-10-01",{"date":39,"type":20},"2029-03-15",{"name":41,"class":42},"Cullinan Therapeutics Inc.","INDUSTRY",11,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100604727","phase-4-treatment-of-vaginal-dryness-in-sjgrens-disease-with-co2-laser-versus-topical-promestriene-100604727","NCT07153276","TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE","TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY","VaLS","Inclusion Criteria:\n\n* Diagnosis of SjD according to the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria (2016).\n* Controlled systemic disease activity \\[EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)\\] \\\u003C 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg\u002Fday.\n* Present complaints of vaginal dryness upon study entry.\n* Agreeing to participate in the protocol according to the informed consent form signed before study inclusion.\n\nExclusion Criteria:\n\n* History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure.\n* Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease.\n* Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.","FEMALE","30 Years","65 Years",{"count":56,"type":20},60,[58],"PHASE4","Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency\u002Fincontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.",[61,27,62],"Sjogren Syndrome","Primary Sjogren Syndrome",[64,65,66,67,68],"Sjogren syndrome","vaginal dryness","vaginitis sicca","vaginal fractional CO2 laser","promestriene","2026-03-02",{"date":71,"type":35},"2026-03-03",{"date":73,"type":35},"2026-02-27",{"date":75,"type":20},"2030-01-30",{"name":77,"class":78},"University of Sao Paulo General Hospital","OTHER",1]