Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS).

This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeNeuro SA
• Collaborators: Institut de Recherches Internationales Servier; Les Laboratoires Servier (LLS); Worldwide Clinical Trials

Criteria

Main Inclusion Criteria:

• For male or female with reproductive potential, use of reliable means of contraception;

• RRMS according to the 2010 revised McDonald criteria;

• Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;

• EDSS score < 6.0.

Main Exclusion Criteria:

• Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;

• Pregnant and nursing women.