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

Active Not RecruitingPhase 2

Sponsor: Denali Therapeutics Inc.

Conditions: Parkinson Disease

Interventions: BIIB122 225 mg, BIIB122-Matching Placebo

Countries: United States, Germany, Israel, Spain

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 overview

Sex: ALL

Age: 30 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (20)

Los Angeles, California, United States
San Francisco, California, United States
Boca Raton, Florida, United States
Boston, Massachusetts, United States
New York, New York, United States
Kirkland, Washington, United States
Spokane, Washington, United States
Dresden, Germany
Lübeck, Germany
Tübingen, Germany
Petah Tikva, Israel
Ramat Gan, Israel
Tel Aviv, Israel
Barcelona, Spain
Barcelona, Spain
Barcelona, Spain
Donostia / San Sebastian, Spain
Madrid, Spain
Santander, Spain
Seville, Spain