NCT03658135

BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TES

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy Syndromes

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients with Four Different Primary Tauopathy Syndromes

Detailed description

This is a phase 1b randomized, double-blind, safety, and tolerability clinical trial of an investigational drug, called BIIB092 in patients with four different primary tauopathy syndromes: amyloid PET (-) corticobasal syndrome (CBS), nonfluent variant primary progressive aphasia (nfvPPA), symptomatic patients with autosomal dominant genetic forms of frontotemporal lobar degeneration (FTD) due to the presence of a mutation in the microtubule-associated protein tau gene (sMAPT), and traumatic encephalopathy syndromes (TES). Primary tauopathies are neurodegenerative brain disorders in which tau is the only protein that accumulates at autopsy. While Alzheimer's disease (AD) is the most common tauopathy, it is considered a secondary tauopathy, because tau protein accumulates along with another pathogenic protein, amyloid beta. Primary tauopathies are rare diseases for which there is no treatment or cure. The purpose of the this study is to characterize the safety and tolerability profile of intravenous BIIB092 in four primary tauopathies. A basket design will be used for a parallel evaluation of BIIB092 in four heterogenous clinicopathological syndromes that share a common molecular target (tau).

Conditions

• Primary Tauopathies
• Corticobasal Degeneration Syndrome
• Frontotemporal Lobar Degeneration With Tau Inclusions
• MAPT Mutation Carriers, Symptomatic
• Traumatic Encephalopathy Syndrome
• Nonfluent Aphasia, Progressive

Interventions

Type	Name	Description
DRUG	BIIB092	BIIB092 is an investigational monoclonal antibody directed at tau protein
OTHER	Placebo	Inactive ingredient

Timeline

• Start date: 2018-09-12
• Primary completion: 2019-12-13
• Completion: 2019-12-13
• First posted: 2018-09-05
• Last updated: 2019-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study