Multiple Sclerosis, Relapsing-RemittingPhase 2ANGEL-MSNCT03239860
Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
A Phase 2 study testing GNbAC1 Monoclonal Antibody in people with Multiple Sclerosis, Relapsing-Remitting, run by GeNeuro SA at 12 sites in 12 countries.
Trial summary
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- GNbAC1 Monoclonal Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 12 sitesin 12 countries
- Study dates
- 6 Jun 2017to 14 Nov 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study
- Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control
- Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form.
Main Exclusion Criteria:
- Patients not having completed the study GNC-003
- Pregnancy
- The emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
Official title: A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis.
The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- GNbAC1 Monoclonal Antibody
- Keywords
- Multiple Sclerosis, Multiple Sclerosis Relapsing-Remitting, GNbAC1, MRI, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, MS, RRMS, HERV-W, Temelimab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNbAC1 Monoclonal AntibodyDrug
Monthly IV
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 GNbAC1 | Experimental | Monthly IV Receives: Drug: GNbAC1 Monoclonal Antibody |
| Dose 2 GNbAC1 | Experimental | Monthly IV Receives: Drug: GNbAC1 Monoclonal Antibody |
| Dose 3 GNbAC1 | Experimental | Monthly IV Receives: Drug: GNbAC1 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety of GNbAC1
The main parameters evaluated to assess the long term safety will be:
AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale
Measured: 96 Weeks
Secondary outcomes (4)
Long term efficacy of GNbAC1 in terms of MRI outcomes
Measured: 96 Weeks
Long term efficacy of GNbAC1 in terms of relapse rate
Measured: 96 Weeks
Long term efficacy of GNbAC1 in terms of disability
Measured: 96 Weeks
Long term efficacy of GNbAC1 in terms of disease progression
Measured: 96 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start6 Jun 2017
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Why it stopped: Based on R\&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.
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 Sclerosis, Relapsing-RemittingStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Les Laboratoires Servier, Worldwide Clinical Trials, Institut de Recherches Internationales Servier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239860
- Sponsor's protocol ID
- GNC-004
- Acronym
- ANGEL-MS
- Status last verified
- Dec 2018
- First submitted
- 12 Jul 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9.
PubMed 34240656
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03239860
- Acronym / sponsor ID
- ANGEL-MS / GNC-004
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Multiple Sclerosis Relapsing-Remitting, GNbAC1, MRI, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, MS, RRMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on R\&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.
- Enrolment
- 220 participants (actual)
- Lead sponsor
- GeNeuro SAIndustry (pharma, biotech, devices)
- Collaborators
- Les Laboratoires Servier, Worldwide Clinical Trials, Institut de Recherches Internationales Servier
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 4 Aug 2017 (actual)
- 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 humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis.
The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 GNbAC1 | Experimental | Drug: GNbAC1 Monoclonal AntibodyMonthly IV |
| Dose 2 GNbAC1 | Experimental | Drug: GNbAC1 Monoclonal AntibodyMonthly IV |
| Dose 3 GNbAC1 | Experimental | Drug: GNbAC1 Monoclonal AntibodyMonthly IV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| GNbAC1 Monoclonal AntibodyMonthly IV | Drug | Dose 1 GNbAC1, Dose 2 GNbAC1, Dose 3 GNbAC1 |
Primary outcome
Long term safety of GNbAC1
Time frame: 96 Weeks
The main parameters evaluated to assess the long term safety will be: AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale
4 secondary outcomes
Long term efficacy of GNbAC1 in terms of MRI outcomes
Time frame: 96 Weeks
Long term efficacy of GNbAC1 in terms of relapse rate
Time frame: 96 Weeks
Long term efficacy of GNbAC1 in terms of disability
Time frame: 96 Weeks
Long term efficacy of GNbAC1 in terms of disease progression
Time frame: 96 Weeks
Results and safety
The study was stopped early (reason given: Based on R\&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Derived from this study: PubMed 34240656Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GNbAC1 Monoclonal Antibody in people with Multiple Sclerosis, Relapsing-Remitting, run by GeNeuro SA at 12 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Bulgaria, Croatia, Czechia, Estonia, Germany and 7 more countries. 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. 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 was stopped early (reason given: Based on R\&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.). Results are not available in the source record.
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?
Long term safety of GNbAC1 (time frame: 96 Weeks). 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 NCT03239860, 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 20 Oct 2020.