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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT06602193

Run by

Denali Therapeutics Inc.

People needed

50

Starts

2024-10-24

Expected to finish

2028-02-28

Last updated by the study team

2026-05-27

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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/Exclusion criteria may apply

Where it is running

• Cedars-Sinai Department of Neurology — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• Parkinson's Disease and Movement Disorders Center — Boca Raton, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center — New York, New York, United States
• Evergreen Health Laboratory — Kirkland, Washington, United States
• Inland Northwest Research — Spokane, Washington, United States
• Technische Universität Dresden — Dresden, Germany
• University of Lübeck — Lübeck, Germany
• University Hospital Tübingen — Tübingen, Germany
• Rabin Medical Center — Petah Tikva, Israel
• Movement Disorders Institute, Sheba Medical Center — Ramat Gan, Israel
• Tel Aviv Medical Center — Tel Aviv, Israel
• Hospital Clinic de Barcelona — Barcelona, Spain
• Hospital Universitari General de Catalunya — Barcelona, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Donostia — Donostia / San Sebastian, Spain
• Universitary Hospital La Princesa — Madrid, Spain
• IDIVAL/University Hospital Marques de Valdecilla — Santander, Spain
• Hospital Universitario Virgen del Rocio — Seville, Spain

Full record on ClinicalTrials.gov

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