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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 June 2021
• Main ID: NCT03716570
• Date of registration: 22/10/2018
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease
• Scientific 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
• Date of first enrolment: March 12, 2019
• Target sample size: 24
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03716570
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: BIIB054

Drug: Placebo

Primary Outcome(s)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to 72 Weeks]

Secondary Outcome(s)

Accumulation Ratio of BIIB054 [Time Frame: Up to 24 Weeks]

Number of Participants With Anti-BIIB054 Antibodies in Serum [Time Frame: Up to 72 Weeks]

Volume of Distribution at Steady State (Vss) of BIIB054 [Time Frame: Up to 24 Weeks]

Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054 [Time Frame: Up to 24 Weeks]

Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054 [Time Frame: Up to 24 Weeks]

Clearance (CL) of BIIB054 [Time Frame: Up to 24 Weeks]

Maximum Observed Serum Concentration (Cmax) of BIIB054 [Time Frame: Up to 24 Weeks]

Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054 [Time Frame: Up to 24 Weeks]

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054 [Time Frame: Up to 24 Weeks]

Terminal Elimination Half-life (t1/2) of BIIB054 [Time Frame: Up to 24 Weeks]

Secondary ID(s)

228PD103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors