Safety Study of GNbAC1 in Multiple Sclerosis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Biological: GNbAC1 placebo; Biological: GNbAC1

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
  • Geneva, Switzerland, 1211
    • Hopitaux Universitaires de Geneve - HUG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.	177 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the pharmacokinetics (PK) characteristics following administration of single ascending doses, as well as of repeated administrations, of GNbAC1 in MS patients	177 days
To determine pharmacodynamic markers of MS disease activity in patients including measurement of MSRV-Env markers and magnetic resonance imaging (MRI)	177 days
To assess the immunogenicity of GNbAC1.	177 days

Collaborators and Investigators

• Sponsor: GeNeuro Innovation SAS
• Investigators: Principal Investigator: Tobias Derfuss, MD, University Hospital, Basel, Switzerland; Principal Investigator: Patrice Lalive, MD, HUG

Publications and helpful links

General Publications

• 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.

Helpful Links

• MedlinePlus related topics: Multiple Sclerosis
• MedlinePlus related topics: Multiple Sclerosis

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (ESTIMATE): July 12, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Relapsing Forms of Multiple Sclerosis; GNbAC1; Temelimab; Multiple Sclerosis Associated Retrovirus (MSRV); Progressive Forms of Multiple Sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: GNC-002