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

ID#: NCT06602193

Age: 30 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: October 24, 2024

End Date: February 28, 2028

Contact Information:
Clinical Trials at Denali Therapeutics
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 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