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Safety Study of GNbAC1 in Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
GNbAC1
GNbAC1 placebo
Sponsored by
GeNeuro Innovation SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis, GNbAC1, Monoclonal antibody, Multiple Sclerosis Associated Retrovirus (MSRV), Temelimab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients (if female, neither pregnant nor breast-feeding, should be post-menopausal or surgically sterile, or should use two highly effective method of contraception such as oral contraception plus mechanical barrier); Male subjects with partners of childbearing potential have to use adequate contraception during the study. Contraception methods should be followed during the study and up to 3 months after the last study drug administration. Female subjects who are women of childbearing potential (WOCBP) will have to be tested negative with a pregnancy test (serum or urine) at screening and Day 1 and before each repeated administrations of GNbAC1.
  • Between 18 and 65 years of age;
  • Patients with Primary Progressive MS (PPMS) according to the Revised McDonald criteria 2010 or patients with Secondary Progressive MS (SPMS) or patients with Relapsing-Remitting MS(RRMS)according to the Revised McDonald criteria 2010 who cannot be treated with available treatments for MS due to intolerance, non response or refusal of treatment;
  • Score ≤ 6.5 on the Expanded Disability Status Scale (EDSS);
  • Body weight between 40 and 100kg.

Exclusion Criteria:

  • Positive serology for viral hepatitis and HIV;
  • Disease other than MS that could better explain his/her signs and symptoms;
  • Previously treated with cladribine, lymphoid irradiation or depleting antibodies;
  • Usage in the last 3 months of interferon beta or glatiramer acetate;
  • Any usage in the last 6 months of mitoxantrone, cytotoxic immunosuppressive therapy, natalizumab, fingolimod or immunoglobulin;
  • Usage within 30 days prior to baseline of oral or systemic corticosteroids or ACTH;
  • Inadequate liver function;
  • Severe renal impairment;
  • Severe psychiatric disorder;
  • Known inability to undergo an MRI scan;
  • Having participated in another clinical study within 6 months prior to study baseline except for patients who have participated or who are currently participating in an interventional study without any study drug intake.
  • Pregnancy or breastfeeding
  • Female subjects considering becoming pregnant during the study

Sites / Locations

  • University Hospital Basel
  • Hopitaux Universitaires de Genève - HUG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GNbAC1

GNbAC1 placebo

Arm Description

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.

Secondary Outcome Measures

To determine the pharmacokinetics (PK) characteristics following administration of single ascending doses, as well as of repeated administrations, of GNbAC1 in MS patients
To determine pharmacodynamic markers of MS disease activity in patients including measurement of MSRV-Env markers and magnetic resonance imaging (MRI)
To assess the immunogenicity of GNbAC1.

Full Information

First Posted
July 10, 2012
Last Updated
February 5, 2021
Sponsor
GeNeuro Innovation SAS
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1. Study Identification

Unique Protocol Identification Number
NCT01639300
Brief Title
Safety Study of GNbAC1 in Multiple Sclerosis Patients
Official Title
Randomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeNeuro Innovation SAS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients. Scientific research has shown that the expression of genes of a virus which is integrated in the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a critical role in the causation of multiple sclerosis. GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV that might contribute to the development or deterioration of multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis, GNbAC1, Monoclonal antibody, Multiple Sclerosis Associated Retrovirus (MSRV), Temelimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GNbAC1
Arm Type
Experimental
Arm Title
GNbAC1 placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
GNbAC1
Intervention Description
Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg
Intervention Type
Biological
Intervention Name(s)
GNbAC1 placebo
Intervention Description
Single dose intravenous (IV) GNbAC1 placebo
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.
Time Frame
177 days
Secondary Outcome Measure Information:
Title
To determine the pharmacokinetics (PK) characteristics following administration of single ascending doses, as well as of repeated administrations, of GNbAC1 in MS patients
Time Frame
177 days
Title
To determine pharmacodynamic markers of MS disease activity in patients including measurement of MSRV-Env markers and magnetic resonance imaging (MRI)
Time Frame
177 days
Title
To assess the immunogenicity of GNbAC1.
Time Frame
177 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients (if female, neither pregnant nor breast-feeding, should be post-menopausal or surgically sterile, or should use two highly effective method of contraception such as oral contraception plus mechanical barrier); Male subjects with partners of childbearing potential have to use adequate contraception during the study. Contraception methods should be followed during the study and up to 3 months after the last study drug administration. Female subjects who are women of childbearing potential (WOCBP) will have to be tested negative with a pregnancy test (serum or urine) at screening and Day 1 and before each repeated administrations of GNbAC1. Between 18 and 65 years of age; Patients with Primary Progressive MS (PPMS) according to the Revised McDonald criteria 2010 or patients with Secondary Progressive MS (SPMS) or patients with Relapsing-Remitting MS(RRMS)according to the Revised McDonald criteria 2010 who cannot be treated with available treatments for MS due to intolerance, non response or refusal of treatment; Score ≤ 6.5 on the Expanded Disability Status Scale (EDSS); Body weight between 40 and 100kg. Exclusion Criteria: Positive serology for viral hepatitis and HIV; Disease other than MS that could better explain his/her signs and symptoms; Previously treated with cladribine, lymphoid irradiation or depleting antibodies; Usage in the last 3 months of interferon beta or glatiramer acetate; Any usage in the last 6 months of mitoxantrone, cytotoxic immunosuppressive therapy, natalizumab, fingolimod or immunoglobulin; Usage within 30 days prior to baseline of oral or systemic corticosteroids or ACTH; Inadequate liver function; Severe renal impairment; Severe psychiatric disorder; Known inability to undergo an MRI scan; Having participated in another clinical study within 6 months prior to study baseline except for patients who have participated or who are currently participating in an interventional study without any study drug intake. Pregnancy or breastfeeding Female subjects considering becoming pregnant during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Derfuss, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrice Lalive, MD
Organizational Affiliation
HUG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Hopitaux Universitaires de Genève - HUG
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25392325
Citation
Derfuss T, Curtin F, Guebelin C, Bridel C, Rasenack M, Matthey A, Du Pasquier R, Schluep M, Desmeules J, Lang AB, Perron H, Faucard R, Porchet H, Hartung HP, Kappos L, Lalive PH. A phase IIa randomised clinical study of GNbAC1, a humanised monoclonal antibody against the envelope protein of multiple sclerosis-associated endogenous retrovirus in multiple sclerosis patients. Mult Scler. 2015 Jun;21(7):885-93. doi: 10.1177/1352458514554052. Epub 2014 Nov 12.
Results Reference
derived
Links:
URL
http://www.nlm.nih.gov/medlineplus/multiplesclerosis.html
Description
MedlinePlus related topics: Multiple Sclerosis
URL
https://www.ncbi.nlm.nih.gov/pubmed/26198921
Description
MedlinePlus related topics: Multiple Sclerosis

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Safety Study of GNbAC1 in Multiple Sclerosis Patients

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