[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657646":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":32,"studyPopulation":11,"armGroups":33,"interventions":49,"overallOfficials":11,"centralContacts":63,"locations":69,"responsibleParty":104,"collaborators":11,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":11,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":11,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":133,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Sundance Biosciences, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo",null,"From enrollment to the end of study at 16 weeks",[14,17],{"measure":15,"description":11,"timeFrame":16},"The maximum concentration (Cmax) of SUN-627 in plasma","From enrollment to end of treatment at 12 weeks",{"measure":18,"description":11,"timeFrame":19},"Change from baseline in neuroinflammation biomarkers","From enrollment to the end of treatment at 12 weeks",{"allocation":21,"interventionModel":22,"interventionModelDescription":11,"primaryPurpose":23,"observationalModel":11,"timePerspective":11,"maskingInfo":24},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":27},"QUADRUPLE","The Sponsor is also masked.",[28,29,30,31],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This Phase 2a, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and impact on measures of neuroinflammation in the central nervous system (CNS) of SUN-627 administered at 2 dose levels in participants with non-active SPMS\u002FPPMS.",[34,40,43],{"label":35,"type":36,"description":37,"interventionNames":38},"SUN-627 Dose Level 1","EXPERIMENTAL","SUN-627, taken orally QD",[39],"Drug: SUN-627",{"label":41,"type":36,"description":37,"interventionNames":42},"SUN-627 Dose Level 2",[39],{"label":44,"type":45,"description":46,"interventionNames":47},"SUN-627 Placebo","PLACEBO_COMPARATOR","SUN-627 Placebo, taken orally QD",[48],"Other: Placebo",[50,58],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","SUN-627","SUN-627, a once daily, orally administered, immediate release tablet",[35,41],[56,57],"NEU-627","N-004850",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"OTHER","Placebo","Orally-administered matched placebo",[44],[64],{"name":65,"role":66,"phone":67,"phoneExt":11,"email":68},"Chetan Gandhy, MD","CONTACT","650-442-3187","clinicaltrials@sundancebio.com",[70,84,94],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":11},"Local Institution - Site 102","RECRUITING","Atlanta","Georgia","30309","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-84.38798,33.749,{"lat":82,"lon":81},{"facility":85,"status":72,"city":86,"state":87,"zip":88,"country":76,"countryCode":77,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"Local Institution - Site 101","Raleigh","North Carolina","27607",{"type":79,"coordinates":90},[91,92],-78.63861,35.7721,{"lat":92,"lon":91},{"facility":95,"status":72,"city":96,"state":97,"zip":98,"country":76,"countryCode":77,"cosmosGeoPoint":99,"geoPoint":103,"contacts":11},"Local Institution - Site 104","Columbus","Ohio","43235",{"type":79,"coordinates":100},[101,102],-82.99879,39.96118,{"lat":102,"lon":101},{"type":105,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657646","phase-2-a-phase-2a-study-of-sun-627-in-participants-with-non-active-secondary-progressive-and-primary-progressive-multiple-sclerosis-spmsppms-100657646",false,"NCT07840326","A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS\u002FPPMS)","A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS\u002FPPMS)","Inclusion Criteria:\n\n1. Aged 18-70, inclusive\n2. Diagnosis of PPMS or non-active SPMS\n3. No MS relapses in the past 2 years\n4. Evidence that MS has continued to get worse over time\n5. A level of disability that fits the study requirements\n\nExclusion Criteria:\n\n1. Use of certain medications or treatments before the study, or need for these treatments during the study\n2. Current participation in another research study\n3. Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk\n4. Certain serious or unstable medical conditions that could make the study unsafe\n5. Active infection, recent infection, or a history of repeated infections\n\nAdditional inclusion and exclusion criteria are outlined in the full study protocol.","ALL","18 Years","70 Years",{"count":117,"type":118},20,"ESTIMATED","INTERVENTIONAL",[121],"PHASE2","The goal of this Phase 2 clinical trial is to investigate the safety and tolerability of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS\u002FPPMS.",[124,125,126,127,128,129,130,131,132],"Primary Progressive Multiple Sclerosis","Primary Progressive MS","Primary Progressive Multiple Sclerosis (PPMS)","Secondary Progressive MS (SPMS)","Secondary Progressive Multiple Sclerosis (SPMS)","Secondary Progressive MS","Non-Active SPMS","Non-Active Secondary Progressive Multiple Sclerosis","Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity",[124,125,126,128,127,134,129,135,130,131,136,137,138,139,140,141,142,143,144,145,146,147,148,149],"Secondary Progressive Multiple Sclerosis","Primary Progressive MS (PPMS)","Secondary Progressive Multiple Sclerosis with inflammatory disease activity","TYK2","CNS penetrant TYK2","Demyelinating disease","CNS demyelinating disease","Multiple Sclerosis","Confirmed disability progression","NfL","GFAP","Neuroinflammation","chronic active lesions","Slowly expanding lesions","Paramagnetic rim lesions","Progressive Multiple sclerosis","2026-09-18",{"date":152,"type":153},"2026-09-25","ACTUAL",{"date":155,"type":118},"2026-10",{"date":157,"type":118},"2027-07",{"name":5,"class":6},3]