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

NCT06602193 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

  • Parkinson Disease

Interventions

DRUG

BIIB122 225 mg

Administered as specified in the treatment arm

OTHER

BIIB122-Matching Placebo

Administered as specified in the treatment arm

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Denali Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Danna Jennings, MD · Denali Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2026-04-30
Completion
2028-02-28
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Israel
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602193 on ClinicalTrials.gov