Actively Recruiting
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Led by Denali Therapeutics Inc. · Updated on 2026-02-18
50
Participants Needed
20
Research Sites
174 weeks
Total Duration
On this page
Sponsors
D
Denali Therapeutics Inc.
Lead Sponsor
B
Biogen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For heterozygous pathogenic LRRK2 mutation carriers: 30 to 80 years old
- For homozygous pathogenic LRRK2 mutation carriers: 30 years or older
- Have screening genetic test results confirming a pathogenic LRRK2 variant
- Have a clinical diagnosis of Parkinson's Disease meeting Movement Disorder Society criteria
You will not qualify if you...
- History of significant neurological disorders other than Parkinson's Disease, including stroke or dementia, within 5 years before screening
- Clinical evidence of atypical parkinsonism or drug-induced parkinsonism
- Previous or current participation in the BIIB122 LUMA study (Study 283PD201)
- Previous or current participation in a gene therapy study for Parkinson's Disease
- History of brain surgery for Parkinson's Disease, such as deep-brain stimulation or pallidotomy
- Physical conditions that could interfere with motor assessments, such as severe arthritis or permanent disability from injuries
- Abnormal vital signs including blood pressure, heart rate, or body temperature
- Abnormal pulmonary function test results at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Cedars-Sinai Department of Neurology
Los Angeles, California, United States, 90048
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
3
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, United States, 33486
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York, New York, United States, 10003
Actively Recruiting
6
Evergreen Health Laboratory
Kirkland, Washington, United States, 98034
Actively Recruiting
7
Inland Northwest Research
Spokane, Washington, United States, 99202
Actively Recruiting
8
Technische Universität Dresden
Dresden, Germany
Actively Recruiting
9
University of Lübeck
Lübeck, Germany
Actively Recruiting
10
University Hospital Tübingen
Tübingen, Germany
Actively Recruiting
11
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
12
Movement Disorders Institute, Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
13
Tel Aviv Medical Center
Tel Aviv, Israel
Actively Recruiting
14
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
15
Hospital Universitari General de Catalunya
Barcelona, Spain
Actively Recruiting
16
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
17
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Actively Recruiting
18
Universitary Hospital La Princesa
Madrid, Spain
Actively Recruiting
19
IDIVAL/University Hospital Marques de Valdecilla
Santander, Spain
Actively Recruiting
20
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
Research Team
C
Clinical Trials at Denali Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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