Trial Purpose

The purpose of this Phase 2 study was to evaluate the safety, tolerability, PK, and efficacy with respect to HD cognitive assessments and Clinical Global Impression of Change of pepinemab (VX15/2503) in participants with late prodromal and early manifest Huntington’s disease.

There are currently no approved disease modifying treatments that impact disease progression in HD.

Vaccinex’s approach is to potentially reprogram the underlying disease pathology that is driven by neuroinflammation with concomitant loss of normal important support functions of glial cells, such as astrocytes and microglia.

About the Trial

This study is now complete. All patients who enrolled in the SIGNAL trial were randomized 1:1 to receive pepinemab or placebo once each month by intravenous infusion. Throughout the study, participants were assessed for clinical features of Huntington’s disease, as well as brain imaging and PK/PD assessments.

Trial Details

Phase

Phase 2

Dates

Actual Study Start Date
July 2015

Completion Date
August 2020

Estimated Publication Date
2022

Sponsor

Vaccinex, Inc.

Products

pepinemab
placebo

Age(s)

21 and older

Condition(s)

Early Manifest and Late Prodromal Huntington’s Disease

Gender(s)

All

Trial Design

 

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