BIIB122 225 mg: Administered as specified in the treatment arm
BIIB122-Matching Placebo: Administered as specified in the treatment arm
Study 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
Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period — 12 weeks
Trial sites (20)
Facility
City
Region
Status
Cedars-Sinai Department of Neurology
Los Angeles
California
University of California San Francisco
San Francisco
California
Parkinson's Disease and Movement Disorders Center
Boca Raton
Florida
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York
New York
Evergreen Health Laboratory
Kirkland
Washington
Inland Northwest Research
Spokane
Washington
Technische Universität Dresden
Dresden
Germany
University of Lübeck
Lübeck
Germany
University Hospital Tübingen
Tübingen
Germany
Rabin Medical Center
Petah Tikva
Israel
Movement Disorders Institute, Sheba Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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