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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02782858
Other study ID # GNC-003
Secondary ID 2015-004059-29
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2016
Est. completion date December 2017

Study information

Verified date January 2018
Source GeNeuro SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date December 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GNbAC1
Monthly IV repeated dose
Placebo
Monthly IV repeated dose

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
GeNeuro SA Institut de Recherches Internationales Servier, Les Laboratoires Servier (LLS), Worldwide Clinical Trials

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Czechia,  Estonia,  Germany,  Hungary,  Italy,  Poland,  Russian Federation,  Serbia,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative number of Gd-enhancing T1 lesions in brain MRI Week 12 to 24
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