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)

Phase 1

Recruiting

• Conditions: Parkinson's Disease; MedDRA version: 20.0Level: PTClassification code: 10061536Term: Parkinson's disease Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-505645-12-00
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-03
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 523

Inclusion Criteria

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

Exclusion Criteria

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, Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism., Montreal Cognitive Assessment (MoCA) score <24 at the screening visit, Other protocol defined Exclusion criteria may apply. See Protocol section 6.2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of BIIB122 225 mg compared with placebo.;Secondary Objective: To evaluate the efficacy, safety and tolerability and of BIIB122 225 mg compared with placebo;Primary end point(s): Time to confirmed worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Incidence of AEs and SAEs during the treatment period;Secondary end point(s):Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period;Secondary end point(s):Change in MDS-UPDRS Parts II and III combined score;Secondary end point(s):Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period;Secondary end point(s):Change in MDS-UPDRS Parts I, II, and III combined score