A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of BIIB122 in participants with Parkinson’s Disease (LUMA)

Prior treatment

• Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.

Other illness

• Clinically significant neurological disorder other than PD, including but not limited to stroke, dementia, or seizure, within 5 years of screening visit, in the opinion of the Investigator

Other

• Montreal Cognitive Assessment (MoCA) score <24 at the screening visit
• Other protocol defined Exclusion criteria may apply. See Protocol section 6.2

• Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the screening visit, inclusive, and at least 30 years of age at the time of diagnosis
• Modified Hoehn and Yahr scale, stages 1 to 2 (in OFF state), inclusive
• MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal to (≤)40 at screening
• Screening genetic test results verifying the absence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant (i.e., G2019S, N1437H, R1441G, R1441C, R1441H, Y1699C, or I2020T). Participants with additional LRRK2 variants may be excluded if data emerge to convincingly support an association of the variants with LRRK2-PD pathogenicity. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.
• Other protocol defined Inclusion criteria may apply. See Protocol section 6.1