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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— CHANGE-MS  

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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