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

Sponsor

GeNeuro SA (Industry)

Overall Status

Completed

CT.gov ID

NCT02782858

Collaborator

Les Laboratoires Servier (LLS) (Other), Institut de Recherches Internationales Servier (Other), Worldwide Clinical Trials (Other)

270

Enrollment

Locations

Arms

Duration (Months)

22.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: GNbAC1 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 GNbAC1 Monthly IV repeated dose	Drug: GNbAC1 Monthly IV repeated dose
Experimental: Dose 2 GNbAC1 Monthly IV repeated dose	Drug: GNbAC1 Monthly IV repeated dose
Experimental: Dose 3 GNbAC1 Monthly IV repeated dose	Drug: GNbAC1 Monthly IV repeated dose
Placebo Comparator: Placebo Monthly IV repeated dose	Drug: Placebo Monthly IV repeated dose

Outcome Measures

Primary Outcome Measures

Cumulative number of Gd-enhancing T1 lesions in brain MRI [Week 12 to 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	Country
1	Sofia	Bulgaria
2	Zagreb	Croatia
3	Jihlava	Czechia
4	Tallinn	Estonia
5	Berlin	Germany
6	Budapest	Hungary
7	Roma	Italy
8	Warsaw	Poland
9	Moscow	Russian Federation
10	Belgrade	Serbia
11	Barcelona	Spain
12	Kharkiv	Ukraine