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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716570
Recruitment Status : Active, not recruiting
First Posted : October 23, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE October 22, 2018
First Posted Date  ICMJE October 23, 2018
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE March 12, 2019
Estimated Primary Completion Date July 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 72 Weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • 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 ]
  • Maximum Observed Serum Concentration (Cmax) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  • Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  • Terminal Elimination Half-life (t1/2) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  • Clearance (CL) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  • Volume of Distribution at Steady State (Vss) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  • Accumulation Ratio 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 ]
  • Number of Participants With Anti-BIIB054 Antibodies in Serum [ Time Frame: Up to 72 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: BIIB054
    Administered as specified in the treatment arm.
  • Drug: Placebo
    Administered as specified in the treatment arm.
Study Arms  ICMJE
  • Experimental: Cohort 1: BIIB054 Dose A
    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)
    Intervention: Drug: BIIB054
  • Experimental: Cohort 2: BIIB054 Dose B
    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)
    Intervention: Drug: BIIB054
  • Experimental: Cohort 3: BIIB054 Dose C
    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)
    Intervention: Drug: BIIB054
  • Placebo Comparator: Cohorts 1-3: Placebo
    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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 22, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 6, 2021
Estimated Primary Completion Date July 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03716570
Other Study ID Numbers  ICMJE 228PD103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: http://www.biogenclinicaldatarequest.com/
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP