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

NCT03716570 | Terminated Phase 1 FDA Drug

• 1 other identifier: 228PD103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 9

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054

  Up to 24 Weeks

• 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

Study Arms (4)

Cohort 1: BIIB054 Dose A

EXPERIMENTAL

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)

Drug: BIIB054

Cohort 2: BIIB054 Dose B

EXPERIMENTAL

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)

Drug: BIIB054

Cohort 3: BIIB054 Dose C

EXPERIMENTAL

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)

Drug: BIIB054

Cohorts 1-3: Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

BIIB054 DRUG

Administered as specified in the treatment arm.

Cohort 1: BIIB054 Dose A; Cohort 2: BIIB054 Dose B; Cohort 3: BIIB054 Dose C

Placebo DRUG

Administered as specified in the treatment arm.

Cohorts 1-3: Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (9)

Research Site

Toon-shi, Ehime, 791-0295, Japan

Location

Research Site

Asahikawa-shi, Hokkaido, 070-8644, Japan

Location

Research Site

Kyoto, Kyoto, 606-8507, Japan

Location

Research Site

Kyoto, Kyoto, 616-8255, Japan

Location

Research Site

Sendai, Miyagi, 980-8574, Japan

Location

Research Site

Sendai, Miyagi, 982-8555, Japan

Location

Research Site

Suita-shi, Osaka, 565-0871, Japan

Location

Research Site

Bunkyō City, Tokyo-To, 113-8431, Japan

Location

Research Site

Kodaira-shi, Tokyo-To, 187-8551, Japan

Location

Related Links

• Fox Trial Finder

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 23, 2018
• Study Start: March 12, 2019
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (9)