Multiple Sclerosis, Relapsing-RemittingPhase 2CHANGE-MSNCT02782858
Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
A Phase 2 study testing GNbAC1 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 (MS). 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Apr 2016to Dec 2017
- 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:
- For male or female with reproductive potential, use of reliable means of contraception;
- RRMS according to the 2010 revised McDonald criteria;
- Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
- EDSS score < 6.0.
Main Exclusion Criteria:
- Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
- Pregnant and nursing women.
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
Official title: An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of 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 (MS).
This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- GNbAC1, Placebo
- 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.
GNbAC1Drug
Monthly IV repeated dose
PlaceboDrug
Monthly IV repeated dose
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 GNbAC1 | Experimental | Monthly IV repeated dose Receives: Drug: GNbAC1 |
| Dose 2 GNbAC1 | Experimental | Monthly IV repeated dose Receives: Drug: GNbAC1 |
| Dose 3 GNbAC1 | Experimental | Monthly IV repeated dose Receives: Drug: GNbAC1 |
| Placebo | Placebo comparator | Monthly IV repeated dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of Gd-enhancing T1 lesions in brain MRI
Measured: Week 12 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionDec 2017
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
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Les Laboratoires Servier (LLS), Institut de Recherches Internationales Servier, Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782858
- Sponsor's protocol ID
- GNC-003
- Other IDs
- 2015-004059-29, 2015
- Acronym
- CHANGE-MS
- Status last verified
- Jan 2018
- First submitted
- 23 May 2016
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
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
- An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02782858
- Acronym / sponsor ID
- CHANGE-MS / GNC-003
- 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
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- GeNeuro SAIndustry (pharma, biotech, devices)
- Collaborators
- Les Laboratoires Servier (LLS), Institut de Recherches Internationales Servier, Worldwide Clinical Trials
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 May 2016 (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 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 (MS).
This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 GNbAC1 | Experimental | Drug: GNbAC1Monthly IV repeated dose |
| Dose 2 GNbAC1 | Experimental | Drug: GNbAC1Monthly IV repeated dose |
| Dose 3 GNbAC1 | Experimental | Drug: GNbAC1Monthly IV repeated dose |
| Placebo | Placebo comparator | Drug: PlaceboMonthly IV repeated dose |
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 |
|---|---|---|
| GNbAC1Monthly IV repeated dose | Drug | Dose 1 GNbAC1, Dose 2 GNbAC1, Dose 3 GNbAC1 |
| PlaceboMonthly IV repeated dose | Drug | Placebo |
Primary outcome
Cumulative number of Gd-enhancing T1 lesions in brain MRI
Time frame: Week 12 to 24
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 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 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: finished, 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. 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?
Cumulative number of Gd-enhancing T1 lesions in brain MRI (time frame: Week 12 to 24). 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 NCT02782858, 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.