[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610558":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Ouro Medicines","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OM336 Dose Escalation","EXPERIMENTAL","Participants will receive OM336 via subcutaneous injection in ascending dose cohorts",[13],"Drug: OM336",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","OM336","OM336 is an engineered bispecific antibody directed against BCMA and CD3",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Study Sponsor","CONTACT","415-429-4887","clinical@ouromeds.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Waikato Hospital","RECRUITING","Hamilton","Waikato Region","3204","New Zealand","NZ",{"type":37,"coordinates":38},"Point",[39,40],175.28333,-37.78333,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Primary Contact","(07) 839 8899","info@waikatodhb.health.nz",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100610558","phase-1-om336-in-seropositive-autoimmune-diseases-100610558",false,"NCT07229144","OM336 in Seropositive Autoimmune Diseases","An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy","Key Inclusion Criteria:\n\n* Diagnosis of active seropositive autoimmune disease\n* Relapsed\u002Frefractory after ≥2 prior\u002Fongoing treatments\n* Body weight ≥ 50 kg\n* Willing to comply with and study requirements and procedures\n\nKey Exclusion Criteria:\n\n* Previous treatment with a BCMA-targeted therapy\n* Clinically significant infection within 3 months of screening\n* Major surgery within 3 months of screening or planned during the study\n* Pregnant or breastfeeding","ALL","18 Years","75 Years",{"count":60,"type":61},39,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.",[67,68],"Sjogrens Disease","Idiopathic Inflammatory Myopathy (IIM)",[17,70],"Ouro","2026-06-11",{"date":73,"type":74},"2026-06-15","ACTUAL",{"date":76,"type":74},"2025-10-01",{"date":78,"type":61},"2028-03",{"name":5,"class":6},1]