Multiple SclerosisPhase 2NCT01639300
Safety Study of GNbAC1 in Multiple Sclerosis Patients
A Phase 2 study testing GNbAC1 in people with Multiple Sclerosis, run by GeNeuro Innovation SAS at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- GNbAC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jul 2012to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel
Basel, 4031
Hopitaux Universitaires de Genève - HUG
Geneva, 1211
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- GNbAC1, GNbAC1 placebo
- Keywords
- Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis, GNbAC1, Monoclonal antibody, Multiple Sclerosis Associated Retrovirus (MSRV), Temelimab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNbAC1Biological
Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg
GNbAC1 placeboBiological
Single dose intravenous (IV) GNbAC1 placebo
| Study group | Role | What they receive |
|---|---|---|
| GNbAC1 | Experimental | Not described Receives: Biological: GNbAC1 |
| GNbAC1 placebo | Placebo comparator | Not described Receives: Biological: GNbAC1 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.
Measured: 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
Measured: 177 days
To determine pharmacodynamic markers of MS disease activity in patients including measurement of MSRV-Env markers and magnetic resonance imaging (MRI)
Measured: 177 days
To assess the immunogenicity of GNbAC1.
Measured: 177 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro Innovation SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Derfuss, MD, Principal investigator, University Hospital, Basel, SwitzerlandPatrice Lalive, MD, Principal investigator, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639300
- Sponsor's protocol ID
- GNC-002
- Status last verified
- Feb 2021
- First submitted
- 10 Jul 2012
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25392325
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01639300
- Acronym / sponsor ID
- GNC-002
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis, GNbAC1, Monoclonal antibody, Multiple Sclerosis Associated Retrovirus (MSRV), Temelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GeNeuro Innovation SASIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNbAC1 | Experimental | Biological: GNbAC1 |
| GNbAC1 placebo | Placebo comparator | Biological: GNbAC1 placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNbAC1Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg | Biological | GNbAC1 |
| GNbAC1 placeboSingle dose intravenous (IV) GNbAC1 placebo | Biological | GNbAC1 placebo |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Derived from this study: PubMed 25392325Derfuss 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.
- MedlinePlus related topics: Multiple SclerosisLink provided by the sponsor.
- MedlinePlus related topics: Multiple SclerosisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Derfuss, MD principal investigator
University Hospital, Basel, Switzerland
Patrice Lalive, MD principal investigator
HUG
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GNbAC1 in people with Multiple Sclerosis, run by GeNeuro Innovation SAS at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01639300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.