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

Biogen

Status and phase: Terminated; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: BIIB054

Study type: Interventional

Funder types: Industry

Identifiers

NCT03716570

228PD103

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

Cohort 1: BIIB054 Dose A

Experimental group

Description:

Participants will receive IV infusion of BIIB054 Dose A (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)

Treatment:

Drug: BIIB054

Cohort 2: BIIB054 Dose B

Experimental group

Description:

Participants will receive IV infusion of BIIB054 Dose B (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)

Treatment:

Drug: BIIB054

Cohort 3: BIIB054 Dose C

Experimental group

Description:

Participants will receive IV infusion of BIIB054 Dose C (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)

Treatment:

Drug: BIIB054

Cohorts 1-3: Placebo

Placebo Comparator group

Description:

Participants will receive a single IV infusion of BIIB054 matching placebo (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)

Treatment:

Drug: Placebo