[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615242":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":104,"collaborators":28,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":28,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},{"fullName":5,"class":6},"Insmed Incorporated","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Participants with sporadic amyotrophic lateral sclerosis (sALS) will be administered INS1202, IT injection at dose level 1 on Day 1.",[13],"Genetic: INS1202",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 2 on Day 1.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 3 on Day 1.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"GENETIC","INS1202","Suspension for injection.",[9,15,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Insmed Medical Information","CONTACT","1-844-446-7633","medicalinformation@insmed.com",[36,53,65,78,91],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"USA004","RECRUITING","La Jolla","California","92037","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-117.2742,32.84727,{"lat":48,"lon":47},[51],{"name":28,"role":32,"phone":28,"phoneExt":28,"email":52},"rprevite@health.ucsd.edu",{"facility":54,"status":38,"city":55,"state":40,"zip":56,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"USA002","Palo 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Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Phase 1, Multicenter, Open-label, Dose-Finding Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection of INS1202 in Patients With Amyotrophic Lateral Sclerosis","ARMOR","Key Inclusion Criteria: -\n\n* Participant with body mass index (BMI) ≥18 kilograms per square meter (kg\u002Fm\\^2).\n* Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria.\n* Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS.\n* SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS.\n* Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention.\n* Baseline ALSFRS-R ≥ 24.\n* ALS disease duration ≤ 42 months.\n\nKey Exclusion Criteria: -\n\n* Previous treatment for ALS with cellular or gene therapies.\n* Any investigational medication or treatment (for ALS or other condition).\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","79 Years",{"count":118,"type":119},23,"ESTIMATED","INTERVENTIONAL",[122],"PHASE1","The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \\\u003C80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.",[125],"Amyotrophic Lateral Sclerosis","2026-06-10",{"date":128,"type":129},"2026-06-12","ACTUAL",{"date":131,"type":129},"2026-01-09",{"date":133,"type":119},"2030-03-31",{"name":135,"class":6},"Insmed Gene Therapy LLC",5]