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

• ClinicalTrials.gov Identifier: NCT03716570
• Recruitment Status: Terminated
• First Posted: October 23, 2018
• Last Update Posted: May 25, 2021
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

Tracking Information

• First Submitted Date: October 22, 2018
• First Posted Date: October 23, 2018
• Last Update Posted Date: May 25, 2021
• Actual Study Start Date: March 12, 2019
• Actual Primary Completion Date: April 23, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Parkinson's Disease

Intervention

• Drug: BIIB054
  Administered as specified in the treatment arm.
• Drug: Placebo
  Administered as specified in the treatment arm.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 22, 2018): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 23, 2021
• Actual Primary Completion Date: April 23, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT03716570
• Other Study ID Numbers: 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

• 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: https://vivli.org/

• Current Responsible Party: Biogen
• Original Responsible Party: Same as current
• Current Study Sponsor: Biogen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Biogen

• PRS Account: Biogen
• Verification Date: May 2021