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

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ClinicalTrials.gov Identifier: NCT03318523
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

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 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 : January 10, 2018
Estimated Primary Completion Date : March 4, 2021
Estimated Study Completion Date : April 6, 2022

Resource links provided by the National Library of Medicine


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.




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.


Secondary Outcome Measures :
  1. Change in Striatal Binding Ratio (SBR) in Putamen, Striatum, and Caudate [ Time Frame: Baseline, Week 52 ]
    SBR will be measured by Striatal-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter With Ioflupane I123 (DaTscan™)

  2. Concentration of BIIB054 in the Serum [ Time Frame: Baseline up to Week 108 ]
  3. Percentage of Participants With Anti-BIIB054 Antibodies in the Serum [ Time Frame: Baseline up to Week 108 ]


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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

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 any medication for the treatment of the motor symptoms of PD 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. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis.
  • 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


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 Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute Active, not recruiting
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute Active, not recruiting
Sun City, Arizona, United States, 85351
United States, California
University of California San Francisco Medical Center Active, not recruiting
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado Health Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Research Site Active, not recruiting
Boca Raton, Florida, United States, 33486
The Compass Clinic Active, not recruiting
Orlando, Florida, United States, 32806
USF Health Byrd Institute Active, not recruiting
Tampa, Florida, United States, 33616
United States, Illinois
Northwestern University PD and Movement Disorders Center Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Louisiana
Ochsner Health System Active, not recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
Research Site Recruiting
Boston, Massachusetts, United States, 02114
Research Site Active, not recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
Quest Research Institute Active, not recruiting
Farmington Hills, Michigan, United States, 48334
United States, North Carolina
Research Site Active, not recruiting
Durham, North Carolina, United States, 27705
Wake Forest Baptist Health Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Washington
Research Site Active, not recruiting
Kirkland, Washington, United States, 98034
Inland Northwest Research Active, not recruiting
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Additional 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: September 5, 2018
Last Verified: August 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
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