NCT02460094

Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 41 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Supranuclear Palsy

Interventions

Type	Name	Description
DRUG	BIIB092	See Arm Descriptions for dosing information.
DRUG	Placebo	See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)

Timeline

• Start date: 2015-10-02
• Primary completion: 2016-10-19
• Completion: 2016-10-19
• First posted: 2015-06-02
• Last updated: 2018-09-04

Locations

13 sites across 1 country: United States