Parkinson's Disease
Conditions
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of BIIB054, administered as intravenous (IV) infusion, in Japanese participants with Parkinson's disease (PD). The secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (PK) profile of BIIB054 after single and multiple dose administration.
Interventions
DRUGBIIB054
Administered as specified in the treatment arm.
DRUGPlacebo
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosed with PD within a maximum of 3 years prior to screening. * Has not received levodopa or any other treatment for PD, herein referred to as symptomatic PD medication (including but, not limited to, dopamine agonists, amantadine, anticholinergics, monoamine oxidase type B (MAO-B) inhibitors, or safinamide) for at least 12 weeks prior to Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. * Score of less than equal to (\<=) 2.5 on the Modified Hoehn and Yahr Scale. * Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reader). Key
Exclusion criteria
* Presence of freezing of gait. * History of or positive test result at Screening for human immunodeficiency virus (HIV) or hepatitis C virus antibody (anti-HCV). * Screening value for hemoglobin less than (\<)12 gram per deciliter (g/dL) for men or \<11 g/dL for women. * Montreal Cognitive Assessment (MoCA) score \<23 or other significant cognitive impairment or clinical dementia. * History of any brain surgery for PD. * Participation in any passive or active immunotherapy targeting alpha-synuclein or other PD-related protein. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 72 Weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event. |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054 | Up to 24 Weeks |
| Maximum Observed Serum Concentration (Cmax) of BIIB054 | Up to 24 Weeks |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054 | Up to 24 Weeks |
| Terminal Elimination Half-life (t1/2) of BIIB054 | Up to 24 Weeks |
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054 | Up to 24 Weeks |
| Volume of Distribution at Steady State (Vss) of BIIB054 | Up to 24 Weeks |
| Accumulation Ratio of BIIB054 | Up to 24 Weeks |
| Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054 | Up to 24 Weeks |
| Number of Participants With Anti-BIIB054 Antibodies in Serum | Up to 72 Weeks |
| Clearance (CL) of BIIB054 | Up to 24 Weeks |
Countries
Japan
Outcome results
None listed