Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy
- Registration Number
- NCT02460094
- Lead Sponsor
- Biogen
- Brief Summary
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.
- Detailed Description
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel 2: BIIB092/ Placebo BIIB092 BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. Panel 1: BIIB092/ Placebo Placebo BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. Panel 3: BIIB092/ Placebo Placebo BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. Panel 2: BIIB092/ Placebo Placebo BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. Panel 4: BIIB092/ Placebo Placebo BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. Panel 4: BIIB092/ Placebo BIIB092 BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. Panel 1: BIIB092/ Placebo BIIB092 BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. Panel 3: BIIB092/ Placebo BIIB092 BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
- Primary Outcome Measures
Name Time Method Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 - Day 169
- Secondary Outcome Measures
Name Time Method Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum Day 1 - Day 169 Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid Day 1 - Day 85 Maximum Serum Concentration (Cmax) of BIIB092 Day 1 - Day 196 Serum Concentration at 4 Weeks After Dosing of BIIB092 Day 1 - Day 196 Time of Maximum Serum Concentration (Tmax) Day 1 - Day 196 Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU)) Day 1 - Day 196 Trough Serum Concentration (Ctrough) of BIIB092 Day 1 - Day 196
Trial Locations
- Locations (13)
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, 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 Minnesota Medical School
🇺🇸Minneapolis, Minnesota, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The University of Chicago Department of Neurology
🇺🇸Chicago, Illinois, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of South Florida
🇺🇸Tampa, Florida, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States