Safety Study of GNbAC1 in Multiple Sclerosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GeNeuro Innovation SAS
ClinicalTrials.gov Identifier:
NCT01639300
First received: July 10, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Biological: GNbAC1
Biological: GNbAC1 placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GeNeuro Innovation SAS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 177 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the immunogenicity of GNbAC1. [ Time Frame: 177 days ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GNbAC1 Biological: GNbAC1
Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg
Placebo Comparator: GNbAC1 placebo Biological: GNbAC1 placebo
Single dose intravenous (IV) GNbAC1 placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639300

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Hopitaux Universitaires de Genève - HUG
Geneva, Switzerland, 1211
Sponsors and Collaborators
GeNeuro Innovation SAS
Investigators
Principal Investigator: Tobias Derfuss, MD University Hospital, Basel, Switzerland
Principal Investigator: Patrice Lalive, MD HUG
  More Information

Additional Information:
No publications provided

Responsible Party: GeNeuro Innovation SAS
ClinicalTrials.gov Identifier: NCT01639300     History of Changes
Other Study ID Numbers: GNC-002
Study First Received: July 10, 2012
Last Updated: April 17, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by GeNeuro Innovation SAS:
Relapsing Forms of Multiple Sclerosis
Progressive Forms of Multiple Sclerosis
GNbAC1
Monoclonal antibody
Multiple Sclerosis Associated Retrovirus (MSRV)

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014