Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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. The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

Official Title
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A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: GNbAC1 Monoclonal Antibody


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form. Main Exclusion Criteria: Patients not having completed the study GNC-003 Pregnancy The emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 GNbAC1<br>Monthly IV | Drug: GNbAC1 Monoclonal Antibody<br>* Monthly IV<br>|
| Experimental: Dose 2 GNbAC1<br>Monthly IV | Drug: GNbAC1 Monoclonal Antibody<br>* Monthly IV<br>|
| Experimental: Dose 3 GNbAC1<br>Monthly IV | Drug: GNbAC1 Monoclonal Antibody<br>* Monthly IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety of GNbAC1 | The main parameters evaluated to assess the long term safety will be: AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale | 96 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term efficacy of GNbAC1 in terms of MRI outcomes |  | 96 Weeks | 
| Long term efficacy of GNbAC1 in terms of relapse rate |  | 96 Weeks | 
| Long term efficacy of GNbAC1 in terms of disability |  | 96 Weeks | 
| Long term efficacy of GNbAC1 in terms of disease progression |  | 96 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Multiple Sclerosis Relapsing-Remitting, GNbAC1, MRI, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, MS, RRMS, HERV-W, Temelimab