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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)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GNbAC1 Monoclonal Antibody
Sponsored by
GeNeuro SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis, Multiple Sclerosis Relapsing-Remitting, GNbAC1, MRI, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, MS, RRMS, HERV-W, Temelimab

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose 1 GNbAC1

Dose 2 GNbAC1

Dose 3 GNbAC1

Arm Description

Monthly IV

Monthly IV

Monthly IV

Outcomes

Primary Outcome Measures

Long term safety of GNbAC1
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

Long term efficacy of GNbAC1 in terms of MRI outcomes
Long term efficacy of GNbAC1 in terms of relapse rate
Long term efficacy of GNbAC1 in terms of disability
Long term efficacy of GNbAC1 in terms of disease progression

Full Information

First Posted
July 12, 2017
Last Updated
October 19, 2020
Sponsor
GeNeuro SA
Collaborators
Les Laboratoires Servier, Worldwide Clinical Trials, Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT03239860
Brief Title
Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
Acronym
ANGEL-MS
Official Title
A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Based on R&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
November 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeNeuro SA
Collaborators
Les Laboratoires Servier, Worldwide Clinical Trials, Institut de Recherches Internationales Servier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple Sclerosis, Multiple Sclerosis Relapsing-Remitting, GNbAC1, MRI, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, MS, RRMS, HERV-W, Temelimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1 GNbAC1
Arm Type
Experimental
Arm Description
Monthly IV
Arm Title
Dose 2 GNbAC1
Arm Type
Experimental
Arm Description
Monthly IV
Arm Title
Dose 3 GNbAC1
Arm Type
Experimental
Arm Description
Monthly IV
Intervention Type
Drug
Intervention Name(s)
GNbAC1 Monoclonal Antibody
Intervention Description
Monthly IV
Primary Outcome Measure Information:
Title
Long term safety of GNbAC1
Description
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
Time Frame
96 Weeks
Secondary Outcome Measure Information:
Title
Long term efficacy of GNbAC1 in terms of MRI outcomes
Time Frame
96 Weeks
Title
Long term efficacy of GNbAC1 in terms of relapse rate
Time Frame
96 Weeks
Title
Long term efficacy of GNbAC1 in terms of disability
Time Frame
96 Weeks
Title
Long term efficacy of GNbAC1 in terms of disease progression
Time Frame
96 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital
City
Sofia
Country
Bulgaria
Facility Name
Hospital
City
Zagreb
Country
Croatia
Facility Name
Hospital
City
Jihlava
Country
Czechia
Facility Name
Hospital
City
Tallinn
Country
Estonia
Facility Name
Hospital
City
Berlin
Country
Germany
Facility Name
Hospital
City
Budapest
Country
Hungary
Facility Name
Hospital
City
Rome
Country
Italy
Facility Name
Hospital
City
Warsaw
Country
Poland
Facility Name
Hospital
City
Moscow
Country
Russian Federation
Facility Name
Hospital
City
Belgrade
Country
Serbia
Facility Name
Hospital
City
Barcelona
Country
Spain
Facility Name
Hospital
City
Kharkiv
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34240656
Citation
Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9.
Results Reference
derived

Learn more about this trial

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

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