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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

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: BIIB054 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : July 6, 2021
Estimated Study Completion Date : July 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: BIIB054
Administered as specified in the treatment arm.

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)
Drug: BIIB054
Administered as specified in the treatment arm.

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)
Drug: BIIB054
Administered as specified in the treatment arm.

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)
Drug: Placebo
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  2. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  3. Maximum Observed Serum Concentration (Cmax) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  4. Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  5. Terminal Elimination Half-life (t1/2) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  6. Clearance (CL) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  7. Volume of Distribution at Steady State (Vss) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  8. Accumulation Ratio of BIIB054 [ Time Frame: Up to 24 Weeks ]
  9. Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054 [ Time Frame: Up to 24 Weeks ]
  10. Number of Participants With Anti-BIIB054 Antibodies in Serum [ Time Frame: Up to 72 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716570


Locations
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Japan
Research Site
Toon-shi, Ehime-Ken, Japan, 791-0295
Research Site
Asahikawa-shi, Hokkaido, Japan, 070-8644
Research Site
Kyoto-shi, Kyoto-Fu, Japan, 606-8507
Research Site
Kyoto-shi, Kyoto-Fu, Japan, 616-8255
Research Site
Sendai-shi, Miyagi-Ken, Japan, 980-8574
Research Site
Sendai-shi, Miyagi-Ken, Japan, 982-8555
Research Site
Suita-shi, Osaka-Fu, Japan, 565-0871
Research Site
Bunkyo-ku, Tokyo-To, Japan, 113-8431
Research Site
Kodaira-shi, Tokyo-To, Japan, 187-8551
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
Additional Information:
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03716570    
Other Study ID Numbers: 228PD103
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (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: http://www.biogenclinicaldatarequest.com/

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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
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases