Safety Study of GNbAC1 in Multiple Sclerosis Patients

• ClinicalTrials.gov Identifier: NCT01639300
• Recruitment Status: Completed
• First Posted: July 12, 2012
• Last Update Posted: February 8, 2021
• Sponsor: GeNeuro Innovation SAS
• Information provided by (Responsible Party): GeNeuro SA ( GeNeuro Innovation SAS )

Tracking Information

• First Submitted Date: July 10, 2012
• First Posted Date: July 12, 2012
• Last Update Posted Date: February 8, 2021
• Study Start Date: July 2012
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 20, 2012): 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 ]
• Original Primary Outcome Measures (submitted: July 10, 2012): To assess the safety and tolerability of single ascending doses of GNbAC1 in MS patients. [ Time Frame: 64 days ]

Current Secondary Outcome Measures (submitted: December 28, 2012)

• 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 ]
• 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 ]
• To assess the immunogenicity of GNbAC1. [ Time Frame: 177 days ]

Original Secondary Outcome Measures (submitted: July 10, 2012)

• To determine pharmacodynamic markers of MS disease activity in patients including measurement of MSRV-Env markers and magnetic resonance imaging (MRI) [ Time Frame: 64 days ]
• To assess the immunogenicity of GNbAC1. [ Time Frame: 64 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

• Biological: GNbAC1
  Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg
• Biological: GNbAC1 placebo
  Single dose intravenous (IV) GNbAC1 placebo

Study Arms

• Experimental: GNbAC1
  Intervention: Biological: GNbAC1
• Placebo Comparator: GNbAC1 placebo
  Intervention: Biological: GNbAC1 placebo

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 10, 2012): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01639300
• Other Study ID Numbers: GNC-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: GeNeuro SA ( GeNeuro Innovation SAS )
• Original Responsible Party: Same as current
• Current Study Sponsor: GeNeuro Innovation SAS
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tobias Derfuss, MD; University Hospital, Basel, Switzerland
• Principal Investigator: Patrice Lalive, MD; HUG

• PRS Account: GeNeuro SA
• Verification Date: February 2021