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

GeNeuro

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Placebo; Drug: GNbAC1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02782858

GNC-003

2015-004059-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 4 patient groups, including a placebo group

Dose 1 GNbAC1

Experimental group

Description:

Monthly IV repeated dose

Treatment:

Drug: GNbAC1

Dose 2 GNbAC1

Experimental group

Description:

Monthly IV repeated dose

Treatment:

Drug: GNbAC1

Dose 3 GNbAC1

Experimental group

Description:

Monthly IV repeated dose

Treatment:

Drug: GNbAC1

Placebo

Placebo Comparator group

Description:

Monthly IV repeated dose

Treatment:

Drug: Placebo