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Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
NCT06602193 · Denali Therapeutics Inc.
In plain English
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Official title
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)
About this study
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.
Eligibility 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
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-10-24
Estimated completion: 2028-02-28
Last updated: 2026-02-18
Interventions
Drug: BIIB122 225 mgOther: BIIB122-Matching Placebo
Primary outcomes
- • 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)
Sponsor
Denali Therapeutics Inc. · industry
With: Biogen
Contacts & investigators
ContactClinical Trials at Denali Therapeutics · contact · clinical-trials@dnli.com
InvestigatorDanna Jennings, MD · study_director, Denali Therapeutics
All locations (20)
Cedars-Sinai Department of NeurologyRecruiting
Los Angeles, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
Parkinson's Disease and Movement Disorders CenterRecruiting
Boca Raton, Florida, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder CenterRecruiting
New York, New York, United States
Evergreen Health LaboratoryRecruiting
Kirkland, Washington, United States
Inland Northwest ResearchRecruiting
Spokane, Washington, United States
Technische Universität DresdenRecruiting
Dresden, Germany
University of LübeckRecruiting
Lübeck, Germany
University Hospital TübingenRecruiting
Tübingen, Germany
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Movement Disorders Institute, Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Medical CenterRecruiting
Tel Aviv, Israel
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital Universitari General de CatalunyaRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Universitario DonostiaRecruiting
Donostia / San Sebastian, Spain
Universitary Hospital La PrincesaRecruiting
Madrid, Spain
IDIVAL/University Hospital Marques de ValdecillaRecruiting
Santander, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Spain