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

GeNeuro

Status and phase: Terminated; Phase 2

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: GNbAC1 Monoclonal Antibody

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03239860

GNC-004

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.

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 3 patient groups

Dose 1 GNbAC1

Experimental group

Description:

Monthly IV

Treatment:

Drug: GNbAC1 Monoclonal Antibody

Dose 2 GNbAC1

Experimental group

Description:

Monthly IV

Treatment:

Drug: GNbAC1 Monoclonal Antibody

Dose 3 GNbAC1

Experimental group

Description:

Monthly IV

Treatment:

Drug: GNbAC1 Monoclonal Antibody