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

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BIIB054
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1: BIIB054 Dose A

Cohort 2: BIIB054 Dose B

Cohort 3: BIIB054 Dose C

Cohorts 1-3: Placebo

Arm 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)

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)

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054
Maximum Observed Serum Concentration (Cmax) of BIIB054
Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054
Terminal Elimination Half-life (t1/2) of BIIB054
Clearance (CL) of BIIB054
Volume of Distribution at Steady State (Vss) of BIIB054
Accumulation Ratio of BIIB054
Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054
Number of Participants With Anti-BIIB054 Antibodies in Serum

Full Information

First Posted
October 22, 2018
Last Updated
May 21, 2021
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT03716570
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Affiliated study NCT03318523 did not meet its primary outcome measure of change from baseline measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and did not demonstrate efficacy on secondary outcome measures
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: BIIB054 Dose A
Arm Type
Experimental
Arm 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)
Arm Title
Cohort 2: BIIB054 Dose B
Arm Type
Experimental
Arm 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)
Arm Title
Cohort 3: BIIB054 Dose C
Arm Type
Experimental
Arm 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)
Arm Title
Cohorts 1-3: Placebo
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
BIIB054
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 72 Weeks
Secondary Outcome Measure Information:
Title
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054
Time Frame
Up to 24 Weeks
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054
Time Frame
Up to 24 Weeks
Title
Maximum Observed Serum Concentration (Cmax) of BIIB054
Time Frame
Up to 24 Weeks
Title
Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054
Time Frame
Up to 24 Weeks
Title
Terminal Elimination Half-life (t1/2) of BIIB054
Time Frame
Up to 24 Weeks
Title
Clearance (CL) of BIIB054
Time Frame
Up to 24 Weeks
Title
Volume of Distribution at Steady State (Vss) of BIIB054
Time Frame
Up to 24 Weeks
Title
Accumulation Ratio of BIIB054
Time Frame
Up to 24 Weeks
Title
Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054
Time Frame
Up to 24 Weeks
Title
Number of Participants With Anti-BIIB054 Antibodies in Serum
Time Frame
Up to 72 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Toon-shi
State/Province
Ehime-Ken
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Research Site
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto-Fu
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto-Fu
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi-Ken
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi-Ken
ZIP/Postal Code
982-8555
Country
Japan
Facility Name
Research Site
City
Suita-shi
State/Province
Osaka-Fu
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo-To
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Research Site
City
Kodaira-shi
State/Province
Tokyo-To
ZIP/Postal Code
187-8551
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
IPD Sharing URL
https://vivli.org/
Links:
URL
https://foxtrialfinder.michaeljfox.org/trial/6140
Description
Fox Trial Finder

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

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