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

GeNeuro SA270 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

270

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

GNbAC1DRUG

Monthly IV repeated dose

PlaceboDRUG

Monthly IV repeated dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (12)

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Zagreb, Croatia

Unnamed facility

Jihlava, Czechia

Unnamed facility

Tallinn, Estonia

Outcomes

Primary Outcomes

Cumulative number of Gd-enhancing T1 lesions in brain MRI

Time frame: Week 12 to 24

Data from ClinicalTrials.gov

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