A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy
Overview
- Phase
- Phase 1
- Intervention
- BIIB092
- Conditions
- Progressive Supranuclear Palsy
- Sponsor
- Biogen
- Enrollment
- 48
- Locations
- 13
- Primary Endpoint
- Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Panel 1: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: BIIB092
Panel 1: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: Placebo
Panel 2: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: BIIB092
Panel 2: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: Placebo
Panel 3: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: BIIB092
Panel 3: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: Placebo
Panel 4: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: BIIB092
Panel 4: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 - Day 169
Secondary Outcomes
- Time of Maximum Serum Concentration (Tmax)(Day 1 - Day 196)
- 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)
- 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)