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CompletedNCT04480307ProTEct-MSUpdated Nov 7, 2024Results posted

Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis

A Phase 2 interventional study of temelimab 18 mg/kg and temelimab 36 mg/kg in Multiple Sclerosis, sponsored by GeNeuro Innovation SAS. Completed at 1 site in Sweden. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by GeNeuro Innovation SAS · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Relapsing Forms of Multiple Sclerosis
  • GNbAC1
  • Human Endogenous Retrovirus Type W
  • HERV-W
  • Temelimab
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 41 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

GeNeuro Innovation SAS is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    temelimab 18 mg/kg

    Monthly IV repeated dose

    Drug: temelimab 18 mg/kg

  • Experimental
    temelimab 36 mg/kg

    Monthly IV repeated dose

    Drug: temelimab 36 mg/kg

  • Experimental
    temelimab 54 mg/kg

    Monthly IV repeated dose

    Drug: temelimab 54 mg/kg

  • Placebo comparator
    Placebo

    Monthly IV repeated dose

    Drug: Placebo

Interventions

  • Drugtemelimab 18 mg/kg

    temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).

  • Drugtemelimab 36 mg/kg

    temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).

  • Drugtemelimab 54 mg/kg

    temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).

  • DrugPlacebo

    Placebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability

    Analysis of Adverse Events (AEs) focused on Treatment Emergent AEs (TEAEs)

    Time frame: 48 weeks

Secondary outcomes

  1. 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).

    Time frame: 48 weeks

  2. 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.

    Time frame: 48 weeks

  3. Neuroimaging

    Change in T1 and T2 lesion volume at Week 48 compared to Baseline

    Time frame: 48 weeks

  4. 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.

    Time frame: 48 weeks

  5. 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.

    Time frame: 48 weeks

07

Results

Posted Nov 7, 2024

Participant flow

Participant flow — Overall Study
MilestoneTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Started11101010
Completed119109
Not completed0101
Withdrew: Withdrawal by subject0100
Withdrew: Adverse event0001

Outcome measures

PrimarySafety and Tolerability

Analysis of Adverse Events (AEs) focused on Treatment Emergent AEs (TEAEs)

Time frame:
48 weeks
Reported as:
Number · Participants with at least one TEAE
Safety and Tolerability
Participants with at least one TEAETemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Safety and Tolerability109109
SecondaryNeuroimaging

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).

Time frame:
48 weeks
Reported as:
Mean · per unit
Neuroimaging
per unitTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Neuroimaging-0.011 ± 0.097-0.060 ± 0.081-0.016 ± 0.1940.008 ± 0.113
Statistical analysis
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · ANCOVA · p = 0.5084 · Ls mean difference: -0.031 · 95% CI -0.124 to 0.063
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · Bayesian · Difference of change from baseline: -0.021 · 95% CI -0.121 to 0.057Difference of change from baseline a posteriori
SecondaryNeuroimaging

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.

Time frame:
48 weeks
Reported as:
Mean · per unit
Neuroimaging
per unitTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Neuroimaging0.037 ± 0.0580.044 ± 0.044-0.013 ± 0.0770.018 ± 0.040
Statistical analysis
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · ANCOVA · p = 0.9472 · Ls mean difference: -0.002 · 95% CI -0.052 to 0.049
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · Bayesian · Difference of change from baseline: 0.012 · 95% CI -0.036 to 0.059Difference of change from Baseline a posteriori.
SecondaryNeuroimaging

Change in T1 and T2 lesion volume at Week 48 compared to Baseline

Time frame:
48 weeks
Reported as:
Mean · mL
Neuroimaging
mLTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Change in T1 lesion volume-0.055 ± 0.315-0.032 ± 0.6860.227 ± 0.405-0.044 ± 0.185
Change in T2 lesion volume0.028 ± 0.0850.029 ± 0.0880.023 ± 0.0610.027 ± 0.075
Statistical analysis
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · ANCOVA · p = 0.4027 · Ls mean difference: 0.154 · 95% CI -0.216 to 0.524
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · ANCOVA · p = 0.7428 · Ls mean difference: 0.01 · 95% CI -0.051 to 0.071
SecondaryNeuroimaging

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.

Time frame:
48 weeks
Reported as:
Median · Ratio
Neuroimaging
RatioTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Neuroimaging-0.013 ± 0.011-0.021 ± 0.032-0.011 ± 0.013-0.019 ± 0.017
Statistical analysis
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · ANCOVA · p = 0.7314 · Ls mean difference: 0.003 · 95% CI -0.013 to 0.018
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · Bayesian · Difference of change from baseline: 0.005 · 95% CI -0.010 to 0.023Difference of change from Baseline a posteriori
SecondaryNeuroimaging

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.

Time frame:
48 weeks
Reported as:
Mean · Ratio
Neuroimaging
RatioTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Neuroimaging-0.000 ± 0.000-0.000 ± 0.000-0.000 ± 0.000-0.000 ± 0.000
Statistical analysis
  • Temelimab 18 mg/kg vs Temelimab 36 mg/kg vs Temelimab 54 mg/kg · ANCOVA · p = 0.7662 · Ls mean difference: 0 · 95% CI 0 to 0

Adverse events

Collected over The collection of Adverse Events (AEs) was from the time the patient signed the informed consent onwards up to Week 48.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Temelimab 18 mg/kg0/11 (0%)1/11 (9.1%)10/11 (90.9%)
Temelimab 36 mg/kg0/10 (0%)0/10 (0%)9/10 (90%)
Temelimab 54 mg/kg0/10 (0%)0/10 (0%)10/10 (100%)
Placebo0/10 (0%)1/10 (10%)9/10 (90%)
Most frequent serious events
Most frequent serious events
EventTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
Urinary tract infectionInfections and infestations0/110/100/101/10
COVID-19Infections and infestations1/110/100/100/10
Most frequent other events
Showing 10 of 56
Most frequent other events
EventTemelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlacebo
NasopharyngitisInfections and infestations5/114/105/103/10
Urinary tract infectionInfections and infestations2/114/100/104/10
PyrexiaGeneral disorders3/111/101/102/10
ArthralgiaMusculoskeletal and connective tissue disorders3/112/101/101/10
COVID-19Infections and infestations3/110/101/102/10
FatigueGeneral disorders1/110/102/100/10
Post lumbar puncture syndromeInjury, poisoning and procedural complications1/110/102/101/10
DizzinessNervous system disorders0/112/101/100/10
VertigoEar and labyrinth disorders0/111/100/102/10
StomatitisGastrointestinal disorders0/112/100/100/10

Baseline characteristics

Randomised set (RS): All patients to whom a therapeutic treatment was randomly assigned using an interactive response system. Patients were analysed in their randomisation group whatever the treatment they received

Age, Categorical
Age, Categorical(Participants)Temelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlaceboTotal
<=18 years00000
Between 18 and 65 years1110101041
>=65 years00000
Age, Continuous
Age, Continuous(years)Temelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlaceboTotal
Mean43.2 ± 7.347.9 ± 6.345.2 ± 10.245.6 ± 9.445.4 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)Temelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlaceboTotal
Female753621
Male457420
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Temelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlaceboTotal
Hispanic or Latino00000
Not Hispanic or Latino101091039
Unknown or Not Reported10102
Region of Enrollment
Region of Enrollment(participants)Temelimab 18 mg/kgTemelimab 36 mg/kgTemelimab 54 mg/kgPlaceboTotal
Sweden1110101041
08

Study locations

1 site
  • Center for Neurology, Academic Specialist Center
    Stockholm, 113 65, Sweden
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 1, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04480307
Lead sponsor
GeNeuro Innovation SAS
Responsible party
Sponsor
First posted
Jul 21, 2020
Start date
Jun 17, 2020
Primary completion
Jan 24, 2022
Completion
Jan 24, 2022
Results posted
Nov 7, 2024
Last update
Nov 7, 2024

Study contacts

David Leppert, MD
study director · GeNeuro Innovation SAS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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