A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03716570
• Other study ID #: 228PD103
• Status: Terminated
• Phase: Phase 1
• Start date: March 12, 2019
• Est. completion date: April 23, 2021

Study information

• Verified date: May 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• BIIB054
Administered as specified in the treatment arm.
• Placebo
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Japan	Research Site	Asahikawa-shi	Hokkaido
Japan	Research Site	Bunkyo-ku	Tokyo-To
Japan	Research Site	Kodaira-shi	Tokyo-To
Japan	Research Site	Kyoto-shi	Kyoto-Fu
Japan	Research Site	Kyoto-shi	Kyoto-Fu
Japan	Research Site	Sendai-shi	Miyagi-Ken
Japan	Research Site	Sendai-shi	Miyagi-Ken
Japan	Research Site	Suita-shi	Osaka-Fu
Japan	Research Site	Toon-shi	Ehime-Ken

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Up to 72 Weeks
Secondary	Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054		Up to 24 Weeks
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054		Up to 24 Weeks
Secondary	Maximum Observed Serum Concentration (Cmax) of BIIB054		Up to 24 Weeks
Secondary	Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054		Up to 24 Weeks
Secondary	Terminal Elimination Half-life (t1/2) of BIIB054		Up to 24 Weeks
Secondary	Clearance (CL) of BIIB054		Up to 24 Weeks
Secondary	Volume of Distribution at Steady State (Vss) of BIIB054		Up to 24 Weeks
Secondary	Accumulation Ratio of BIIB054		Up to 24 Weeks
Secondary	Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054		Up to 24 Weeks
Secondary	Number of Participants With Anti-BIIB054 Antibodies in Serum		Up to 72 Weeks

External Links

•   Fox Trial Finder