[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjgren\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjgren":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,141],{"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":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":123,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100289408","the-myelin-disorders-biorepository-project-100289408","NCT03047369","The Myelin Disorders Biorepository Project","The Myelin Disorders Biorepository Project and Global Leukodystrophy Initiative Clinical Trials Network","MDBP","Inclusion Criteria (Affected Subjects):\n\n* Male or female of any age;\n* Suspected or confirmed diagnosis of leukodystrophy or other disorder affecting the white matter of the brain based primarily on the finding of central nervous system neuroimaging consistent with this diagnosis or on an existing diagnosis of a leukodystrophy or genetic leukoencephalopathy as defined in existing classification systems, or in the presence of variant(s) of uncertain significance or genotype consistent with leukodytrophy;\n* Documentation of informed consent by the subject, parent, or legal guardian, and, if appropriate, documentation of assent;\n* Willingness to provide clinical data, participate in standardized assessments, and\u002For provide biologic samples.\n\nExclusion Criteria (Affected Subjects)\n\n* Established diagnosis at the time of referral that is not consistent with a genetic disorder of the white matter, such as an acquired demyelinating condition (e.g. multiple sclerosis), or an infectious etiology, with the exception of sequelae of congenital infections such as CMV;\n* Inability to provide consent.\n\nInclusion Criteria (Healthy Controls)\n\n* Male or female of any age;\n* Individuals with no confirmed or suspected diagnosis of leukodystrophy or other disorder affecting the white matter of the brain (including affected patients' caregivers);\n* Documentation of informed consent by the subject, parent, or legal guardian, and, if appropriate, documentation of assent.\n\nExclusion Criteria (Healthy Controls)\n\n\\- Inability to provide consent.",{"count":53,"type":20},12000,"10 Years","OBSERVATIONAL","The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects. The MDBP is one of the world's largest leukodystrophy biorepositories, having enrolled nearly 2,000 affected individuals since it was launched over a decade ago.\n\nResearchers working in the biorepository hope to use these materials to uncover new genetic etiologies for various leukodystrophies, develop biomarkers for use in future clinical trials, and better understand the natural history of these disorders. The knowledge gained from these efforts may help improve the diagnostic tools and treatment options available to patients in the future.",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,26,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122],"Leukodystrophy","White Matter Disease","Leukoencephalopathies","4H Syndrome","Adrenoleukodystrophy","AMN","ALD","ALD Gene Mutation","ALD (Adrenoleukodystrophy)","X-linked Adrenoleukodystrophy","X-ALD","Adrenomyeloneuropathy","Aicardi Goutieres Syndrome","AGS","Alexander Disease","Alexanders Leukodystrophy","AxD","ADLD","Canavan Disease","CTX","Cerebrotendinous Xanthomatoses","Krabbe Disease","GALC Deficiency","Globoid Leukodystrophy","TUBB4A-Related Leukodystrophy","H-ABC - Hypomyelination, Atrophy of Basal Ganglia and Cerebellum","HBSL","HBSL - Hypomyelination, Brain Stem, Spinal Cord, Leg Spasticity","LBSL","Leukoencephalopathy With Brain Stem and Spinal Cord Involvement and High Lactate Syndrome (Disorder)","Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation","ALSP","CSF1R Gene Mutation","HCC - Hypomyelination and Congenital Cataract","MLC1","Megalencephalic Leukoencephalopathy With Subcortical Cysts","MLD","Metachromatic Leukodystrophy","PMD","Pelizaeus-Merzbacher Disease","PLP1 Null Syndrome","PLP1 Gene Duplication | Blood or Tissue | Mutations","Pelizaeus Merzbacher Like Disease","Peroxisomal Biogenesis Disorder","Zellweger Syndrome","Refsum Disease","Salla Disease","Sialic Storage Disease","Sjogren-Larsson Syndrome","Van Der Knapp Disease","Vanishing White Matter Disease","Charcot-Marie-Tooth","CMT","Mct8 (Slc16A2)-Specific Thyroid Hormone Cell Transporter Deficiency","Allan-Herndon-Dudley Syndrome","Cadasil","Cockayne Syndrome","Multiple Sulfatase Deficiency","Gangliosidoses","GM2 Gangliosidosis","BPAN","Labrune Syndrome","LCC","Mucopolysaccharidoses","TBCK-Related Intellectual Disability Syndrome",[124,125,126,127,128,129],"leukodystrophy","white matter disease","leukoencephalopathy","myelin","demyelinating","mdbp","2025-10-22",{"date":132,"type":35},"2025-10-23",{"date":134,"type":35},"2016-12-08",{"date":136,"type":20},"2030-12-08",{"name":138,"class":139},"Children's Hospital of Philadelphia","OTHER",23,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100538928","phase-1-r-2487-in-patients-with-sjogrens-syndrome-ss-100538928","NCT06297213","R-2487 in Patients With Sjogren's Syndrome (SS)","A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Sjogren's Syndrome (SS)","R-2487-SS-01","Inclusion Criteria:\n\n* Diagnosis of SS according to American-European Consensus Group Criteria\n* Able to provide informed consent\n* Subjects receiving prednisone (10 mg or less\u002Fday) must be on a stable dose for more than 2 weeks\n* All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product.\n* The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.\n\nExclusion Criteria:\n\n* No known active overlapping or associated other autoimmune disease\n* Prior allogenic or autologous bone marrow or organ transplantation\n* Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism\n* Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.\n* Subjects with positive results for human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n* Subjects with active viral, bacterial, or fungal infection, or history of severe opportunistic infection within the preceding 3 months, or COVID-19 infection in the past 3 months\n* Subjects with evidence of active or latent tuberculosis\n* Active infection of the salivary or lacrimal glands\n* Prior immunotherapy, biologics, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to the first dose of R-2487 DP\n* Pregnant or breastfeeding women\n* Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:\n\nHemoglobin level \\\u003C 9.0 g\u002FdL\n\nAbsolute white blood cell (WBC) count of \\\u003C3.0×109\u002FL (\\\u003C3000\u002Fmm3), or absolute neutrophil count of \\\u003C1.2×109\u002FL (\\\u003C1200\u002Fmm3), or absolute lymphocyte count of \\\u003C0.8×109\u002FL (\\\u003C800\u002Fmm3).\n\nThrombocytopenia, defined by platelet count \\\u003C100×109\u002FL (\\\u003C100,000\u002Fmm3)\n\nChronic kidney disease defined as Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2, based on the age appropriate calculation.\n\nProteinuria ≥3+.\n\nTotal bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN).\n\nPreviously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (\\> F3)\n\n* Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.\n* Subjects should not receive any of the following medications:\n\nRituximab or belimumab within 6 months prior to Day 1 Abatacept within 3 months prior to Day 1 Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months prior to Day 1 Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1\n\n* Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).","80 Years",{"count":19,"type":20},[23],"The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.\n\nPatients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.",[28,26,154],"Sjögren Syndrome, Unspecified",[28],"NOT_YET_RECRUITING","2025-08-27",{"date":159,"type":35},"2025-09-04",{"date":161,"type":20},"2026-06-01",{"date":163,"type":20},"2028-08-30",{"name":165,"class":42},"Rise Therapeutics LLC"]