The purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BIIB092 in participants with Progressive Supranuclear Palsy (PSP). The study will also assess the pharmacodynamic (PD) effects of BIIB092 on cerebrospinal fluid (CSF) N-terminal tau, pharmacokinetics (PK), and immunogenicity of BIIB092 in participants with PSP.
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Same dose as corresponding CN002003 study panel.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Diego
La Jolla, California, United States
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths
Time frame: Day 1 through study completion (approximately 1.5 years or later)
Percentage of Participants with Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements, ECGs, and Physical and Neurological Examinations
Time frame: Day 1 through study completion (approximately 1.5 years or later)
Serum Trough Concentration (C-trough) of BIIB092
Time frame: Up to study completion (approximately 1.5 years or later)
End-of-Infusion Serum Concentration of BIIB092
Time frame: Day 1 through study completion (approximately 1.5 years or later)
Number of Participants with drug antibodies (anti-BIIB092) in Serum
Time frame: Up to study completion (approximately 1.5 years or later)
Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48
Time frame: Baseline, Week 48
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
Boca Raton, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
...and 3 more locations