Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

• Status: Terminated
• Trial end date: 2018-11-14
• 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.

The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

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

Details

• Lead Sponsor: GeNeuro SA
• Collaborators: Institut de Recherches Internationales Servier; Les Laboratoires Servier; Worldwide Clinical Trials
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Main Inclusion Criteria:

• Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study

• Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control

• Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form.

Main Exclusion Criteria:

• Patients not having completed the study GNC-003

• Pregnancy

• The emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms