Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
Phase 2
Completed
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: GNbAC1Drug: Placebo
- Registration Number
- NCT02782858
- Lead Sponsor
- GeNeuro SA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
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
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Exclusion Criteria
- Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
- Pregnant and nursing women.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 1 GNbAC1 GNbAC1 Monthly IV repeated dose Dose 2 GNbAC1 GNbAC1 Monthly IV repeated dose Dose 3 GNbAC1 GNbAC1 Monthly IV repeated dose Placebo Placebo Monthly IV repeated dose
- Primary Outcome Measures
Name Time Method Cumulative number of Gd-enhancing T1 lesions in brain MRI Week 12 to 24
- Secondary Outcome Measures
Name Time Method