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

October 19, 2020 updated by: GeNeuro SA

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose 1 GNbAC1
Monthly IV
Drug: GNbAC1 Monoclonal Antibody
Monthly IV
EXPERIMENTAL: Dose 2 GNbAC1
Monthly IV
Drug: GNbAC1 Monoclonal Antibody
Monthly IV
EXPERIMENTAL: Dose 3 GNbAC1
Monthly IV
Drug: GNbAC1 Monoclonal Antibody
Monthly IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term safety of GNbAC1
Time Frame: 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
96 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GeNeuro SA

Collaborators

Worldwide Clinical Trials
Institut de Recherches Internationales Servier
Les Laboratoires Servier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2017

Primary Completion (ACTUAL)

November 14, 2018

Study Completion (ACTUAL)

November 14, 2018

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (ACTUAL)

August 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNC-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis, Relapsing-Remitting

Clinical Trials on GNbAC1 Monoclonal Antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe