Clinical Trial: Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy

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 pharmacodynamics of BMS-986168 on cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in patients with Progressive Supranuclear Palsy.

Detailed Summary:
Sponsor: Bristol-Myers Squibb

Current Primary Outcome: Safety and tolerability. [ Time Frame: Day 1 - Day 169 ]

Original Primary Outcome: Safety and tolerability, as measured by incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical and neurological examinations. [ Time Frame: Day 1 - Day 169 ]

To evaluate the safety and tolerability of intravenous (IV) infusions of BMS-986168 in Patients With Progressive Supranuclear Palsy.


Current Secondary Outcome:

  • Pharmacokinetics of BMS-986168 in serum. [ Time Frame: Day 1 - Day 169 ]
  • Pharmacodynamic (PD) effects of BMS-986168 on extracellular tau (eTau) in cerebrospinal fluid. [ Time Frame: Day 1 - Day 169 ]
  • Immunogenicity of BMS-986168 measured by presence or absence of anti-BMS-986168 antibodies in serum. [ Time Frame: Day 1 - Day 169 ]


Original Secondary Outcome:

  • Maximum observed serum concentration (Cmax) of BMS-986168. [ Time Frame: Day 1 - Day 169 ]
  • Trough serum concentration (Ctrough) of BMS-986168. [ Time Frame: Day 1 - Day 169 ]
  • Serum concentration at four weeks after dosing (C4W) of BMS-986168. [ Time Frame: Day 1 - Day 169 ]
  • Area under the concentration-time curve in dosing interval (AUC(TAU) of BMS-986168. [ Time Frame: Day 1 - Day 169 ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986168. [ Time Frame: Day 1 - Day 169 ]
  • Pharmacodynamics (PD) of BMS-986168, measured by CSF for assessment of free eTau and corresponding percent change from baseline. [ Time Frame: Day 1 - Day 169 ]
  • Assess immunogenicity of BMS-986168 for the presence or absence of specific drug antibodies (anti-BMS-986168) in serum. [ Time Frame: Day 1 - Day 169 ]


Information By: Bristol-Myers Squibb

Dates:
Date Received: May 20, 2015
Date Started: September 2015
Date Completion: August 2017
Last Updated: September 6, 2016
Last Verified: September 2016