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
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-sclerosis
Started Jul 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFebruary 8, 2021
February 1, 2021
1.8 years
July 10, 2012
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.
177 days
Secondary Outcomes (3)
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
Study Arms (2)
GNbAC1
EXPERIMENTALGNbAC1 placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Basel
Basel, 4031, Switzerland
Hopitaux Universitaires de Genève - HUG
Geneva, 1211, Switzerland
Related Publications (1)
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.
PMID: 25392325DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Derfuss, MD
University Hospital, Basel, Switzerland
- PRINCIPAL INVESTIGATOR
Patrice Lalive, MD
HUG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 12, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
February 8, 2021
Record last verified: 2021-02