Clinical Trial: Extension Study of BMS-986168 in Patients With Progressive Supranuclear Palsy Who Participated in CN002003

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN0

Brief Summary: The purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BMS-986168 in patients with Progressive Supranuclear Palsy (PSP). The study will also assess the pharmacodynamic (PD) effects of BMS-986168 on cerebrospinal fluid (CSF) extracellular tau (eTau), pharmacokinetics (PK), and immunogenicity of BMS-986168 in patients with Progressive Supranuclear Palsy.

Detailed Summary:
Sponsor: Bristol-Myers Squibb

Current Primary Outcome: Safety and tolerability measured by incidence of adverse events (AEs) [ Time Frame: Day 1 through study completion, approximately 1.5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics of BMS-986168 in serum measured by Trough Serum Concentration (Ctrough) [ Time Frame: Day 1 through study completion, approximately 1.5 years ]
  • Pharmacokinetics of BMS-986168 in serum measured by End-of-Infusion Serum Concentration (Cinf) [ Time Frame: Day 1 through study completion, approximately 1.5 years ]
  • Pharmacodynamic (PD) effects of BMS-986168 on extracellular tau (eTau) in cerebrospinal fluid (CSF) measured by percent change in CSF concentrations of eTau [ Time Frame: Day 1 through study completion, approximately 1.5 years ]
  • Immunogenicity of BMS-986168 measured by presence or absence of anti-BMS-986168 antibodies in serum [ Time Frame: Day 1 through study completion, approximately 1.5 years ]


Original Secondary Outcome: Same as current

Information By: Bristol-Myers Squibb

Dates:
Date Received: January 13, 2016
Date Started: February 2016
Date Completion: May 2019
Last Updated: February 17, 2016
Last Verified: February 2016