Evaluating the safety and effects of BIIB122 in patients with LRRK2-related Parkinson's Disease
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)
This study is testing a new drug called BIIB122 to see if it is safe and helpful for people with Parkinson's Disease caused by a specific genetic change.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Denali Therapeutics Inc. Industry-sponsored |
| Locations | 20 sites (Los Angeles, California and 19 other locations) |
| Trial ID | NCT06602193 on ClinicalTrials.gov |
What this trial studies
This Phase 2a clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants diagnosed with LRRK2-associated Parkinson's Disease. The study will involve a 12-week treatment period followed by an open-label extension phase. Participants must be carriers of a pathogenic LRRK2 variant and meet specific diagnostic criteria for Parkinson's Disease. The trial aims to gather data on how the drug affects patients with this genetic form of the disease.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 80 who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant and have a clinical diagnosis of Parkinson's Disease.
Not a fit: Patients with atypical parkinsonism or significant neurological disorders other than Parkinson's Disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option specifically targeting the genetic causes of Parkinson's Disease.
How similar studies have performed: Other studies targeting genetic forms of Parkinson's Disease have shown promise, but this specific approach with BIIB122 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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/Exclusion criteria may apply
Where this trial is running
Los Angeles, California and 19 other locations
- Cedars-Sinai Department of Neurology — Los Angeles, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Parkinson's Disease and Movement Disorders Center — Boca Raton, Florida, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center — New York, New York, United States (Recruiting)
- Evergreen Health Laboratory — Kirkland, Washington, United States (Recruiting)
- Inland Northwest Research — Spokane, Washington, United States (Recruiting)
- Technische Universität Dresden — Dresden, Germany (Recruiting)
- University of Lübeck — Lübeck, Germany (Recruiting)
- University Hospital Tübingen — Tübingen, Germany (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Movement Disorders Institute, Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Tel Aviv Medical Center — Tel Aviv, Israel (Recruiting)
- Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitari General de Catalunya — Barcelona, Spain (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitario Donostia — Donostia / San Sebastian, Spain (Recruiting)
- Universitary Hospital La Princesa — Madrid, Spain (Recruiting)
- IDIVAL/University Hospital Marques de Valdecilla — Santander, Spain (Recruiting)
- Hospital Universitario Virgen del Rocio — Seville, Spain (Recruiting)
Study contacts
- Study coordinator: Clinical Trials at Denali Therapeutics
- Email: clinical-trials@dnli.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.