Multiple SclerosisPhase 2ProTEct-MSNCT04480307
Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 2 study testing temelimab 18 mg/kg, temelimab 36 mg/kg and temelimab 54 mg/kg in people with Multiple Sclerosis, run by GeNeuro Innovation SAS at 1 site in Sweden.
Trial summary
Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- temelimab 18 mg/kg, temelimab 36 mg/kg and temelimab 54 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jun 2020to 24 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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:
- Current diagnosis of RMS, based on McDonald 2017 criteria
- Having received treatment with rituximab, as per local clinical routine for at least 12 months prior to the Screening Visit
- Having received their last dose of rituximab not more than 8 weeks and not less than 4 weeks before Randomization (Study Day 1)
- Having expanded disability status scale (EDSS) 2.5 - 5.5 inclusive at Screening
- Present clinical worsening in one or more neurological domains as assessed by EDSS, ambulatory function as assessed by 6MWT or T25FW, cognitive functioning as assessed by SDMT or increased need of walking aids or pharmacological/procedures for bowel and bladder functions over the last year.
Main Exclusion Criteria:
- Current diagnosis of primary progressive MS (PPMS)
- Any disease other than MS (e.g. myelitis and /or bilateral optic neuritis) that could better explain the patient's signs and symptoms
- Usage of any of the following medications prior to the Screening visit:
- Any usage of interferon beta, glatiramer acetate, IV immunoglobulin (IVIG), dimethyl fumarate or teriflunomide within 12 months prior to Screening,
- Any history of exposure to mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation at any time,
- Any usage of natalizumab within 24 months prior to Screening,
- Any usage of highly potent immune modulating therapy, such as: ocrelizumab, ofatumumab, fingolimod, siponimod, ozanimod or anti-cytokine therapy, plasmapheresis or azathioprine within 12 months prior to Screening,
- Any usage of any experimental treatment if not washed out for ≥ 5 half-lives or ≥ 12 months (whichever is longer), except rituximab which is allowed before the study.
- CTCAE Grade 2 or greater lymphopenia
- Any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study
- History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4)
- Any history of cancer with the exceptions of basal cell carcinoma and/or carcinoma in situ of the cervix, and only if successfully treated by complete surgical resection, with documented clean margins and any medically unstable condition as determined by the investigator
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Neurology, Academic Specialist Center
Stockholm, 113 65
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)
Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg).
In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.
- Conditions
- Multiple Sclerosis
- Being tested
- temelimab 18 mg/kg, temelimab 36 mg/kg, temelimab 54 mg/kg, Placebo
- Keywords
- Relapsing Forms of Multiple Sclerosis, GNbAC1, Human Endogenous Retrovirus Type W, HERV-W, 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.
temelimab 18 mg/kgDrug
temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
temelimab 36 mg/kgDrug
temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
temelimab 54 mg/kgDrug
temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
PlaceboDrug
Placebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
| Study group | Role | What they receive |
|---|---|---|
| temelimab 18 mg/kg | Experimental | Monthly IV repeated dose Receives: Drug: temelimab 18 mg/kg |
| temelimab 36 mg/kg | Experimental | Monthly IV repeated dose Receives: Drug: temelimab 36 mg/kg |
| temelimab 54 mg/kg | Experimental | Monthly IV repeated dose Receives: Drug: temelimab 54 mg/kg |
| 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.
Safety and Tolerability
Analysis of Adverse Events (AEs) focused on Treatment Emergent AEs (TEAEs)
Measured: 48 weeks
Secondary outcomes (5)
Neuroimaging
Change in magnetization transfer saturation (MT Sat) in periventricular NAWM at Week 48 compared to Baseline. The MT Sat represents the fraction of free water, as transformed to per-unit scale, saturated by a single Magnetization transfer (MT) pulse during repetition time (TR).
Measured: 48 weeks
Neuroimaging
Change in magnetization transfer saturation (MT Sat) in cortex at Week 48 compared to Baseline. The MT Sat represents the fraction of free water, as transformed to per-unit scale, saturated by a single Magnetization transfer pulse during repetition time.
Measured: 48 weeks
Neuroimaging
Change in T1 and T2 lesion volume at Week 48 compared to Baseline
Measured: 48 weeks
Neuroimaging
Change in brain parenchymal volume fraction at Week 48 compared to Baseline. The brain parenchymal fraction is defined as the ratio of brain parenchymal volume to the total volume within the brain surface contour.
Measured: 48 weeks
Neuroimaging
Change in thalamic volume fraction at Week 48 compared to Baseline. The thalamic volume fraction is the ratio of the legitimate (i.e. thalamic) brain tissue volume to the total volume within the brain surface contour.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start17 Jun 2020
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro Innovation SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Leppert, MD, Study director, GeNeuro Innovation SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480307
- Sponsor's protocol ID
- GNC-401
- Other IDs
- 2019-004822-15, 2019
- Acronym
- ProTEct-MS
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2020
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)
- ClinicalTrials.gov ID
- NCT04480307
- Acronym / sponsor ID
- ProTEct-MS / GNC-401
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing Forms of Multiple Sclerosis, GNbAC1, Human Endogenous Retrovirus Type W, HERV-W, Temelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- GeNeuro Innovation SASIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg).
In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.
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 |
|---|---|---|
| temelimab 18 mg/kg | Experimental | Drug: temelimab 18 mg/kgMonthly IV repeated dose |
| temelimab 36 mg/kg | Experimental | Drug: temelimab 36 mg/kgMonthly IV repeated dose |
| temelimab 54 mg/kg | Experimental | Drug: temelimab 54 mg/kgMonthly 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 |
|---|---|---|
| temelimab 18 mg/kgtemelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total). | Drug | temelimab 18 mg/kg |
| temelimab 36 mg/kgtemelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total). | Drug | temelimab 36 mg/kg |
| temelimab 54 mg/kgtemelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total). | Drug | temelimab 54 mg/kg |
| PlaceboPlacebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total). | Drug | Placebo |
Primary outcome
Safety and Tolerability
Time frame: 48 weeks
Analysis of Adverse Events (AEs) focused on Treatment Emergent AEs (TEAEs)
5 secondary outcomes
Neuroimaging
Time frame: 48 weeks
Neuroimaging
Time frame: 48 weeks
Neuroimaging
Time frame: 48 weeks
Neuroimaging
Time frame: 48 weeks
Neuroimaging
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Leppert, MD study director
GeNeuro Innovation SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temelimab 18 mg/kg, temelimab 36 mg/kg and temelimab 54 mg/kg in people with Multiple Sclerosis, run by GeNeuro Innovation SAS at 1 site in Sweden.
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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.