NCT06602193

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

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Denali Therapeutics Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BIIB122 225 mg	Administered as specified in the treatment arm
OTHER	BIIB122-Matching Placebo	Administered as specified in the treatment arm

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-04-30
• Completion: 2028-02-28
• First posted: 2024-09-19
• Last updated: 2026-02-18

Locations

20 sites across 4 countries: United States, Germany, Israel, Spain

Regulatory

• FDA-regulated drug study