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Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease (SPARK)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03318523
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the dose-related safety of BIIB054, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, to assess the pharmacokinetic (PK) profile of BIIB054 and to evaluate the immunogenicity of BIIB054.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Placebo Drug: BIIB054 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo

Year 1: Participants will receive matching placebo to BIIB054 on Day 1 and then every 4 weeks.

Year 2: Participants who received placebo in year 1 will be randomized into one of the active treatment arms in year 2 and will receive BIIB054 intravenous (IV) infusion on Week 52 and then every 4 weeks.

Drug: Placebo
Administered as specified in the treatment arm
Experimental: BIIB054 250 mg
Participants will receive BIIB054 250 mg intravenous (IV) infusion on Day 1 and then every 4 weeks.
Drug: BIIB054
Administered as specified in the treatment arm.
Experimental: BIIB054 1250 mg
Participants will receive BIIB054 1250 mg IV infusion on Day 1 and then every 4 weeks.
Drug: BIIB054
Administered as specified in the treatment arm.
Experimental: BIIB054 3500 mg
Participants will receive BIIB054 3500 mg IV infusion on Day 1 and then every 4 weeks.
Drug: BIIB054
Administered as specified in the treatment arm.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs) [ Time Frame: Up to Week 52 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization, results in persistent or significant disability and/or results in a congenital anomaly.

  2. Change From Baseline in Clinical Laboratory Test Data [ Time Frame: Baseline, Week 52 ]
  3. Change From Baseline in Vital Sign Measurements [ Time Frame: Baseline, Week 52 ]
  4. Change From Baseline in Neurological and Physical Examination Findings [ Time Frame: Baseline, Week 52 ]
  5. Change From Baseline in Electrocardiograms (ECGs) [ Time Frame: Baseline, Week 52 ]
  6. Change From Baseline in Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures :
  1. Change in Striatal Binding Ratio (SBR) in Putamen, Striatum, and Caudate as Measured by Striatal-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter With Ioflupane I123 (DaTscan™) [ Time Frame: Baseline, Week 52 ]
  2. Concentration of BIIB054 in the Serum [ Time Frame: Baseline and at multiple time points (up to 2 years) ]
  3. Percentage of Participants With Anti-BIIB054 Antibodies in the Serum [ Time Frame: Baseline and at multiple time points (up to 2 years) ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria

  • Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
  • Score of ≤2.5 on the Modified Hoehn and Yahr Scale.
  • Has not received levodopa or any other treatment for PD (dopamine agonists, amantadine, anticholinergics, MAO-B inhibitors, or safinamide) for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days.
  • Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading).
  • All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.

Exclusion Criteria:

  • Presence of freezing of gait.
  • MOCA score <23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
  • History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
  • History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
  • Participation in any active immunotherapy study targeting alpha-synuclein.
  • Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
  • Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
  • Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).

NOTE : Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

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): NCT03318523


Contacts
Contact: US Biogen Medical Information 866-633-4636 clinicaltrials@biogen.com

Locations
United States, Florida
Research Site Recruiting
Boca Raton, Florida, United States, 33486
Research Site Recruiting
Orlando, Florida, United States, 32806
Research Site Recruiting
Tampa, Florida, United States, 33616
United States, Michigan
Research Site Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Washington
Research Site Recruiting
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03318523     History of Changes
Other Study ID Numbers: 228PD201
2016-0044610-95 ( Other Identifier: European Medicines Agency (EudraCT) )
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biogen:
BIIB054
Parkinson's Disease
Alpha-synuclein
Alpha synuclein

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