Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

Launched by DENALI THERAPEUTICS INC. · Sep 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BIIB122 for people with a specific type of Parkinson's Disease known as LRRK2-associated Parkinson's Disease (LRRK2-PD). The trial aims to find out if BIIB122 is safe to use and how it affects the body over 12 weeks. It is being conducted at multiple locations and involves participants who have a genetic mutation that affects the LRRK2 protein, which is linked to Parkinson's Disease. The trial is currently recruiting participants aged 30 to 80 who meet certain health criteria.

To participate, individuals must have a confirmed LRRK2 mutation and a clinical diagnosis of Parkinson's Disease. However, those with other significant neurological disorders or certain health issues may not be eligible. Participants will be randomly assigned to receive either the study drug or a placebo (a non-active treatment) and will be monitored closely throughout the trial. This study is important because it could help researchers understand how BIIB122 works and whether it could be a new option for treating LRRK2-PD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply