drugset / Trial / NCT01639300

Safety Study of GNbAC1 in Multiple Sclerosis Patients

NCT01639300 ↗

Phase 2 Completed 10 enrolled GeNeuro Innovation SAS
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients. Scientific research has shown that the expression of genes of a virus which is integrated in the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a critical role in the causation of multiple sclerosis. GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV that might contribute to the development or deterioration of multiple sclerosis.

Timeline

Start
2012-07
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Temelimab Monoclonal antibody 2 mg/kg Intravenous
Subject Temelimab Monoclonal antibody 6 mg/kg Intravenous

Indications