Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
NCT ID: NCT03318523
Last Updated: 2022-02-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
357 participants
INTERVENTIONAL
2018-01-10
2021-04-29
Brief Summary
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The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Placebo
Administered as specified in the treatment arm
BIIB054 250 mg
Participants will receive BIIB054 250 milligrams (mg) intravenous (IV) infusion on Day 1 and then every 4 weeks.
BIIB054
Administered as specified in the treatment arm.
BIIB054 1250 mg
Participants will receive BIIB054 1250 mg IV infusion on Day 1 and then every 4 weeks.
BIIB054
Administered as specified in the treatment arm.
BIIB054 3500 mg
Participants will receive BIIB054 3500 mg IV infusion on Day 1 and then every 4 weeks.
BIIB054
Administered as specified in the treatment arm.
Interventions
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Placebo
Administered as specified in the treatment arm
BIIB054
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* 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
* Montreal cognitive assessment (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).
40 Years
80 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute
Phoenix, Arizona, United States
Research Site
La Jolla, California, United States
Cedars Sinai
Los Angeles, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Research Site
Stanford, California, United States
University of Colorado Health
Aurora, Colorado, United States
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, United States
Parkinson's Disease and Movement Disorders Centerf
Boca Raton, Florida, United States
Mayo Clinic Hospital
Jacksonville, Florida, United States
Bioclinica Research
Orlando, Florida, United States
USF Health Byrd Institute
Tampa, Florida, United States
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, United States
Research Site
Chicago, Illinois, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Ochsner Health System
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
NYU Langone Health Center
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Research Site
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Booth Gardner Parkinson's Care Center at Evergreen Health
Kirkland, Washington, United States
Inland Northwest Research
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Research Site
Innsbruck, , Austria
University Health Network
Toronto, Ontario, Canada
Montreal Neurological Institute Clinical Research Unit
Montreal, Quebec, Canada
Research Name
Toulouse, Haute Garonne, France
CHU Nantes - Hopital Nord Laënnec
Nantes, Loire Atlantique, France
Hopital Roger Salengro - CHU Lille
Lille, Nord, France
Hôpital Henri Mondor
Créteil, Val De Marne, France
Research Site
Paris, , France
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany
Paracelsus-Elena-Klinik
Kassel, Hesse, Germany
Universitaetsklinikum Aachen AOeR
Aachen, North Rhine-Westphalia, Germany
Research Site
Bochum, North Rhine-Westphalia, Germany
Research Site
Haifa, , Israel
Research Site
Tel Aviv, , Israel
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Pozzilli, Isernia, Italy
Ospedale Bellaria
Bologna, , Italy
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, , Italy
Research Site
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Research Site
Milan, , Italy
Seconda Università degli Studi di Napoli
Napoli, , Italy
Research Site
Pisa, , Italy
IRCCS San Raffaele
Roma, , Italy
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, , Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, , Italy
Hospital General de Catalunya
Sant Cugat Del Vallés, Barcelona, Spain
Research Site
Móstoles, Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Biocruces Health Research Institute
Barakaldo, Vizcaya, Spain
Hospital Clinic De Barcalona
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Seville, , Spain
Research Site
Cambridge, Cambridgeshire, United Kingdom
Salford Royal
Salford, Greater Manchester, United Kingdom
Research Site
Oxford, Oxfordshire, United Kingdom
Clinical Ageing Research Unit
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Royal Hallamshire Hospital
Sheffield, West Midlands, United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Hutchison RM, Fraser K, Yang M, Fox T, Hirschhorn E, Njingti E, Scott D, Bedell BJ, Kistner KM, Cedarbaum JM, Evans KC, Graham D, Martarello L, Mollenhauer B, Lang AE, Dam T, Beaver J. Cinpanemab in Early Parkinson Disease: Evaluation of Biomarker Results From the Phase 2 SPARK Clinical Trial. Neurology. 2024 Mar 12;102(5):e209137. doi: 10.1212/WNL.0000000000209137. Epub 2024 Feb 5.
Lang AE, Siderowf AD, Macklin EA, Poewe W, Brooks DJ, Fernandez HH, Rascol O, Giladi N, Stocchi F, Tanner CM, Postuma RB, Simon DK, Tolosa E, Mollenhauer B, Cedarbaum JM, Fraser K, Xiao J, Evans KC, Graham DL, Sapir I, Inra J, Hutchison RM, Yang M, Fox T, Budd Haeberlein S, Dam T; SPARK Investigators. Trial of Cinpanemab in Early Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):408-420. doi: 10.1056/NEJMoa2203395.
Hutchison RM, Evans KC, Fox T, Yang M, Barakos J, Bedell BJ, Cedarbaum JM, Brys M, Siderowf A, Lang AE. Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial. BMC Neurol. 2021 Nov 23;21(1):459. doi: 10.1186/s12883-021-02470-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Fox Trial Finder
Other Identifiers
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2016-004610-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
228PD201
Identifier Type: -
Identifier Source: org_study_id
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