Trials / Completed
CompletedNCT02782858
Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 270 (actual)
- Sponsor
- GeNeuro SA · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GNbAC1 | Monthly IV repeated dose |
| DRUG | Placebo | Monthly IV repeated dose |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2017-08-01
- Completion
- 2017-12-01
- First posted
- 2016-05-25
- Last updated
- 2020-10-20
Locations
12 sites across 12 countries: Bulgaria, Croatia, Czechia, Estonia, Germany, Hungary, Italy, Poland, Russia, Serbia, Spain, Ukraine
Source: ClinicalTrials.gov record NCT02782858. Inclusion in this directory is not an endorsement.