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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03239860
Recruitment Status : Terminated (Based on R&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.)
First Posted : August 4, 2017
Last Update Posted : October 20, 2020
Sponsor:
Collaborators:
Les Laboratoires Servier
Worldwide Clinical Trials
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
GeNeuro SA

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: GNbAC1 Monoclonal Antibody Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : November 14, 2018
Actual Study Completion Date : November 14, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Long term efficacy of GNbAC1 in terms of MRI outcomes [ Time Frame: 96 Weeks ]
  2. Long term efficacy of GNbAC1 in terms of relapse rate [ Time Frame: 96 Weeks ]
  3. Long term efficacy of GNbAC1 in terms of disability [ Time Frame: 96 Weeks ]
  4. Long term efficacy of GNbAC1 in terms of disease progression [ Time Frame: 96 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239860


Locations
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Bulgaria
Hospital
Sofia, Bulgaria
Croatia
Hospital
Zagreb, Croatia
Czechia
Hospital
Jihlava, Czechia
Estonia
Hospital
Tallinn, Estonia
Germany
Hospital
Berlin, Germany
Hungary
Hospital
Budapest, Hungary
Italy
Hospital
Rome, Italy
Poland
Hospital
Warsaw, Poland
Russian Federation
Hospital
Moscow, Russian Federation
Serbia
Hospital
Belgrade, Serbia
Spain
Hospital
Barcelona, Spain
Ukraine
Hospital
Kharkiv, Ukraine
Sponsors and Collaborators
GeNeuro SA
Les Laboratoires Servier
Worldwide Clinical Trials
Institut de Recherches Internationales Servier
More Information
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Responsible Party: GeNeuro SA
ClinicalTrials.gov Identifier: NCT03239860    
Other Study ID Numbers: GNC-004
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GeNeuro SA:
Multiple Sclerosis
Multiple Sclerosis Relapsing-Remitting
GNbAC1
MRI
Monoclonal antibody
 Multiple Sclerosis associated retrovirus MSRV
MS
RRMS
HERV-W
Temelimab
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs