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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06602193

Enrollment

Registered

2024-09-19

Start date

2024-10-24

Completion date

2028-02-28

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

LRRK2, Movement Disorders

Brief 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.

Interventions

DRUGBIIB122 225 mg

Administered as specified in the treatment arm

OTHERBIIB122-Matching Placebo

Administered as specified in the treatment arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12	12 weeks
Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12	12 weeks

Countries

Germany, Israel, Spain, United States

Contacts

CONTACTClinical Trials at Denali Therapeutics

clinical-trials@dnli.com

STUDY_DIRECTORDanna Jennings, MD

Denali Therapeutics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026