Clinical trial NCT03716570: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease
Official title: A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 72 Weeks
Secondary outcomes:
measure: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054
timeFrame: Up to 24 Weeks
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054
timeFrame: Up to 24 Weeks
measure: Maximum Observed Serum Concentration (Cmax) of BIIB054
timeFrame: Up to 24 Weeks
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054
timeFrame: Up to 24 Weeks
measure: Terminal Elimination Half-life (t1/2) of BIIB054
timeFrame: Up to 24 Weeks
measure: Clearance (CL) of BIIB054
timeFrame: Up to 24 Weeks
measure: Volume of Distribution at Steady State (Vss) of BIIB054
timeFrame: Up to 24 Weeks
measure: Accumulation Ratio of BIIB054
timeFrame: Up to 24 Weeks
measure: Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054
timeFrame: Up to 24 Weeks
measure: Number of Participants With Anti-BIIB054 Antibodies in Serum
timeFrame: Up to 72 Weeks
Other outcomes:
Locations:
city: Toon-shi
country: Japan
facility: Research Site
state: Ehime-Ken
city: Asahikawa-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto-Fu
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto-Fu
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi-Ken
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi-Ken
city: Suita-shi
country: Japan
facility: Research Site
state: Osaka-Fu
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo-To
city: Kodaira-shi
country: Japan
facility: Research Site
state: Tokyo-To
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: