Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-04 @ 11:59 PM
Study NCT ID:
NCT06602193
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730636', 'term': 'DNL151'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of TEAEs and SAEs during the OLE period', 'timeFrame': '2.5 years'}], 'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LRRK2', 'Movement Disorders'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06602193', 'briefTitle': "Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Denali Therapeutics Inc.'}, 'officialTitle': "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)", 'orgStudyIdInfo': {'id': 'DNLI-C-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIIB122 225 mg', 'description': 'Oral 225 mg dose, once daily (QD)', 'interventionNames': ['Drug: BIIB122 225 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'BIIB122 Matching Placebo', 'description': 'Oral BIIB122 matching placebo, once daily (QD)', 'interventionNames': ['Other: BIIB122-Matching Placebo']}], 'interventions': [{'name': 'BIIB122 225 mg', 'type': 'DRUG', 'otherNames': ['DNL151'], 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['BIIB122 225 mg']}, {'name': 'BIIB122-Matching Placebo', 'type': 'OTHER', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['BIIB122 Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Tran', 'role': 'CONTACT', 'email': 'anne.tran@cshs.org', 'phone': '310-423-1697'}, {'name': 'Michele Tagliati, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Department of Neurology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luisa Bolo Dave', 'role': 'CONTACT', 'email': 'Luisa.Bolodave@ucsf.edu'}, {'name': 'Marta San Luciano Palenzuela, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stuart Isaacson, MD', 'role': 'CONTACT', 'email': 'info@ParkinsonsCenter.org', 'phone': '(561)392-1818'}, {'name': 'Stuart Isaacson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Parkinson's Disease and Movement Disorders Center", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jackie Forbes', 'role': 'CONTACT', 'email': 'jforbes1@bidmc.harvard.edu', 'phone': '617-667-9885'}, {'name': 'Ludy Shih, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ricardo Renvill', 'role': 'CONTACT', 'email': 'Ricardo.Renvill@mountsinai.org', 'phone': '212-844-6055'}, {'name': 'Matthew Swan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'EvergreenHealth Research Department', 'role': 'CONTACT', 'email': 'EvergreenResearch@evergreenhealthcare.org'}, {'name': 'Pinky Agarwal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evergreen Health Laboratory', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Aldred, MD', 'role': 'CONTACT', 'email': 'jaldred@selkirkneurology.com', 'phone': '509-960-2818'}, {'name': 'Jason Aldred, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inland Northwest Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marian Kollaske', 'role': 'CONTACT', 'email': 'Marian.Kollaske@ukdd.de'}, {'name': 'Björn Falkenburger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Madita Grümmer', 'role': 'CONTACT', 'email': 'madita.gruemmer@uni-luebeck.de'}, {'name': 'Norbert Brüggemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Solbrig', 'role': 'CONTACT', 'email': 'Susanne.Solbrig@med.uni-tuebingen.de'}, {'name': 'Thomas Gasser, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Susana Andrade', 'role': 'CONTACT', 'email': 's.andrade@udic.es', 'phone': '+3493175715'}, {'name': 'Ernest Balaguer Martínez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitari General de Catalunya', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alejandra Garcia Blanco', 'role': 'CONTACT', 'email': 'alejandra.garcia@vhir.org'}, {'name': 'Jorge Hernandez-Vara, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Donostia / San Sebastian', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ioana Croitoru', 'role': 'CONTACT', 'email': 'ioana.croitoru@bio-gipuzkoa.eus'}, {'name': 'Javier Ruiz Martinez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Donostia', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo Sáinz-Ezquerra', 'role': 'CONTACT', 'email': 'p.sainzezquerra@gmail.com'}, {'name': 'Lydia Lopez-Manzares, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitary Hospital La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raquel Martinez', 'role': 'CONTACT', 'email': 'raquel.martinez@scsalud.es'}, {'name': 'Jon Infante, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IDIVAL/University Hospital Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Gomez Rapela', 'role': 'CONTACT', 'email': 'cgomez-ibis@us.es'}, {'name': 'Lorena Garrote', 'role': 'CONTACT', 'email': 'lgarrote-ibis@us.es'}, {'name': 'Pablo Mir Rivera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Clinical Trials at Denali Therapeutics', 'role': 'CONTACT', 'email': 'clinical-trials@dnli.com'}], 'overallOfficials': [{'name': 'Danna Jennings, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Denali Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denali Therapeutics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}