The purpose of this study is to evaluate the safety and tolerability of multiple ascending intravenous infusions of BMS-986168 and to assess the pharmacokinetics and immunogenicity of BIIB092, and pharmacodynamics of BIIB092 on cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in participants with Progressive Supranuclear Palsy.
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
The University of Alabama at Birmingham
Birmingham, Alabama, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California San Diego
Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 - Day 169
Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid
Time frame: Day 1 - Day 85
Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum
Time frame: Day 1 - Day 169
Maximum Serum Concentration (Cmax) of BIIB092
Time frame: Day 1 - Day 196
Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU))
Time frame: Day 1 - Day 196
Trough Serum Concentration (Ctrough) of BIIB092
Time frame: Day 1 - Day 196
Serum Concentration at 4 Weeks After Dosing of BIIB092
Time frame: Day 1 - Day 196
Time of Maximum Serum Concentration (Tmax)
Time frame: Day 1 - Day 196
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San Diego, California, United States
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, United States
Parkinsons Disease and Movement Disorders Center of Boca Raton
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 Department of Neurology
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