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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2018-11-14

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.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1 GNbAC1

Monthly IV

Group Type EXPERIMENTAL

GNbAC1 Monoclonal Antibody

Intervention Type DRUG

Monthly IV

Dose 2 GNbAC1

Monthly IV

Group Type EXPERIMENTAL

GNbAC1 Monoclonal Antibody

Intervention Type DRUG

Monthly IV

Dose 3 GNbAC1

Monthly IV

Group Type EXPERIMENTAL

GNbAC1 Monoclonal Antibody

Intervention Type DRUG

Monthly IV

Interventions

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GNbAC1 Monoclonal Antibody

Monthly IV

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No