Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biogen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB122 225 mg | Experimental | Oral 225 mg dose, once daily (QD) |
|
| BIIB122 Matching Placebo | Placebo Comparator | Oral BIIB122 matching placebo, once daily (QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB122 225 mg | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs and SAEs during the OLE period | 2.5 years |
Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Danna Jennings, MD | Denali Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Department of Neurology | Los Angeles | California | 90048 | United States | ||
| University of California San Francisco |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BIIB122-Matching Placebo | Other | Administered as specified in the treatment arm |
|
| San Francisco |
| California |
| 94158 |
| United States |
| Parkinson's Disease and Movement Disorders Center | Boca Raton | Florida | 33486 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center | New York | New York | 10003 | United States |
| Evergreen Health Laboratory | Kirkland | Washington | 98034 | United States |
| Inland Northwest Research | Spokane | Washington | 99202 | 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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000730636 | DNL151 |
Not provided
Not provided
Not provided