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

Phase 2

Terminated

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: GNbAC1 Monoclonal Antibody

• Registration Number: NCT03239860
• Lead Sponsor: GeNeuro SA

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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-06
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-04
• Primary Completion: 2018-11-14
• Study Completion: 2018-11-14
• Status Verified: 2018-12
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 GNbAC1	GNbAC1 Monoclonal Antibody	Monthly IV
Dose 2 GNbAC1	GNbAC1 Monoclonal Antibody	Monthly IV
Dose 3 GNbAC1	GNbAC1 Monoclonal Antibody	Monthly IV

Primary Outcome Measures

Name	Time	Method
Long term safety of GNbAC1	96 Weeks	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

Secondary Outcome Measures

Name	Time	Method
Long term efficacy of GNbAC1 in terms of disability	96 Weeks
Long term efficacy of GNbAC1 in terms of disease progression	96 Weeks
Long term efficacy of GNbAC1 in terms of MRI outcomes	96 Weeks
Long term efficacy of GNbAC1 in terms of relapse rate	96 Weeks

Trial Locations

Locations (1)

Hospital; 🇺🇦 Kharkiv, Ukraine