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)
Denali Therapeutics Inc.
50 participants
Oct 24, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria8
- 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
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT06602193