[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06602193":3,"trial-entities:NCT06602193":211,"trial-summary:NCT06602193":215},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":42,"secondary_outcomes":46,"sex":51,"minimum_age":52,"maximum_age":15,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":70,"locations":73,"central_contacts":203,"overall_officials":204,"references":209,"see_also_links":210},"NCT06602193","DNLI-C-0009","Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)","A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)","ACTIVE_NOT_RECRUITING","2028-02-28","2026-05","2026-05-27","2024-10-24","Denali Therapeutics Inc.","INDUSTRY",null,"This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.",[18],"Parkinson Disease",[20,21],"LRRK2","Movement Disorders","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},50,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","BIIB122 225 mg","Administered as specified in the treatment arm",[32],[36],"DNL151",{"type":38,"name":39,"description":33,"armGroupLabels":40},"OTHER","BIIB122-Matching Placebo",[41],"BIIB122 Matching Placebo",[43],{"measure":44,"timeFrame":45},"Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period","12 weeks",[47,49],{"measure":48,"timeFrame":45},"Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12",{"measure":50,"timeFrame":45},"Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12","ALL","30 Years",false,{"inclusion":55,"exclusion":60,"raw_text":69},[56,57,58,59],"For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years","For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years","Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.","Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.",[61,62,63,64,65,66,67,68],"Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.","Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.","Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).","Have previously participated or are currently participating in a gene therapy study for PD.","Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).","Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).","Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature","Have abnormal PFT results at screening","Inclusion Criteria:\n\n* For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years\n* For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years\n* Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.\n* Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.\n\nExclusion Criteria:\n\n* Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.\n* Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.\n* Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).\n* Have previously participated or are currently participating in a gene therapy study for PD.\n* Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).\n* Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).\n* Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature\n* Have abnormal PFT results at screening\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",[71,72],"ADULT","OLDER_ADULT",[74,83,90,98,106,113,121,128,135,141,147,154,160,166,173,176,179,185,191,197],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Cedars-Sinai Department of Neurology","Los Angeles","California","90048","United States",{"lat":81,"lon":82},34.05223,-118.24368,{"facility":84,"city":85,"state":77,"zip":86,"country":79,"geoPoint":87},"University of California San Francisco","San Francisco","94158",{"lat":88,"lon":89},37.77493,-122.41942,{"facility":91,"city":92,"state":93,"zip":94,"country":79,"geoPoint":95},"Parkinson's Disease and Movement Disorders Center","Boca Raton","Florida","33486",{"lat":96,"lon":97},26.35869,-80.0831,{"facility":99,"city":100,"state":101,"zip":102,"country":79,"geoPoint":103},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"lat":104,"lon":105},42.35843,-71.05977,{"facility":107,"city":108,"state":108,"zip":109,"country":79,"geoPoint":110},"Ichan School of Medicine at Mount Sinai\u002FBeth Israel Downtown-Movement Disorder Center","New York","10003",{"lat":111,"lon":112},40.71427,-74.00597,{"facility":114,"city":115,"state":116,"zip":117,"country":79,"geoPoint":118},"Evergreen Health Laboratory","Kirkland","Washington","98034",{"lat":119,"lon":120},47.68149,-122.20874,{"facility":122,"city":123,"state":116,"zip":124,"country":79,"geoPoint":125},"Inland Northwest Research","Spokane","99202",{"lat":126,"lon":127},47.65966,-117.42908,{"facility":129,"city":130,"country":131,"geoPoint":132},"Technische Universität Dresden","Dresden","Germany",{"lat":133,"lon":134},51.05089,13.73832,{"facility":136,"city":137,"country":131,"geoPoint":138},"University of Lübeck","Lübeck",{"lat":139,"lon":140},53.86893,10.68729,{"facility":142,"city":143,"country":131,"geoPoint":144},"University Hospital Tübingen","Tübingen",{"lat":145,"lon":146},48.52266,9.05222,{"facility":148,"city":149,"country":150,"geoPoint":151},"Rabin Medical Center","Petah Tikva","Israel",{"lat":152,"lon":153},32.0888,34.88666,{"facility":155,"city":156,"country":150,"geoPoint":157},"Movement Disorders Institute, Sheba Medical Center","Ramat Gan",{"lat":158,"lon":159},32.08227,34.81065,{"facility":161,"city":162,"country":150,"geoPoint":163},"Tel Aviv Medical Center","Tel Aviv",{"lat":164,"lon":165},32.08088,34.78057,{"facility":167,"city":168,"country":169,"geoPoint":170},"Hospital Clinic de Barcelona","Barcelona","Spain",{"lat":171,"lon":172},41.38879,2.15899,{"facility":174,"city":168,"country":169,"geoPoint":175},"Hospital Universitari General de Catalunya",{"lat":171,"lon":172},{"facility":177,"city":168,"country":169,"geoPoint":178},"Hospital Universitari Vall d'Hebron",{"lat":171,"lon":172},{"facility":180,"city":181,"country":169,"geoPoint":182},"Hospital Universitario Donostia","Donostia \u002F San Sebastian",{"lat":183,"lon":184},43.31283,-1.97499,{"facility":186,"city":187,"country":169,"geoPoint":188},"Universitary Hospital La Princesa","Madrid",{"lat":189,"lon":190},40.4165,-3.70256,{"facility":192,"city":193,"country":169,"geoPoint":194},"IDIVAL\u002FUniversity Hospital Marques de Valdecilla","Santander",{"lat":195,"lon":196},43.46589,-3.80493,{"facility":198,"city":199,"country":169,"geoPoint":200},"Hospital Universitario Virgen del Rocio","Seville",{"lat":201,"lon":202},37.38283,-5.97317,[],[205],{"name":206,"affiliation":207,"role":208},"Danna Jennings, MD","Denali Therapeutics","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":212,"biomarkers":213},[18],[214],"LRRK2 Gene",{"nct_id":4,"found":53,"summary":15,"prompt_version":15}]