Multiple Sclerosis MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
GeNeuro Innovation SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has given written informed consent to participate in the study 2. Current diagnosis of RMS, based on the McDonald 2017 criteria 3. Having received treatment with rituximab, as per local clinical routine for at least 12 months prior to the Screening Visit 4. Having received their last dose of rituximab not more than 8 weeks and not less than 4 weeks before Randomization (Study Day 1) 5. Having B-cell count 9 T2 cerebral lesions (assessed within the last 24 months) 9. Stable clinical presentation of MS for 30 days prior to Screening e.g. no relapse, no acute neurological exacerbation. 10. Age range from 18 to 55 years (both inclusive) 11. Body weight between 40 – 100 kg (both ranges are inclusive) 12. No disease modifying therapies (DMTs) other than rituximab, within 12 months of Screening 13. No contraindication to Biomarker assessments: brain Magnetic resonance imaging (MRI), blood/serum collection and cerebrospinal fluid (CSF) collection 14. Agreeing to undergo two lumbar puncture 15. Be willing and able to follow all study procedures and assessments according to the study protocol 16. Female patients of childbearing potential (FPCBP) or procreative male patients (PMP), willing to use highly effective contraceptive methods throughout the study duration and at least until 5 months after the last study treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of primary progressive MS (PPMS) 2. Any disease other than MS (e.g. myelitis and /or bilateral optic neuritis) that could better explain the patient’s signs and symptoms 3. Usage of any of the following medications prior to the Screening visit: a) Any usage of interferon beta, glatiramer acetate, IV immunoglobulin (IVIG), dimethyl fumarate or teriflunomide within 12 months prior to Screening, b) Any history of exposure to mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation at any time, c) Any usage of natalizumab within 24 months prior to Screening, d) 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, e) 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. 4. CTCAE Grade 2 or greater lymphopenia 5. Any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study, including: a) Diagnosis or history of schizophrenia b) Current diagnosis of moderate to severe bipolar disorder, major depressive disorder, major depressive episode, history of suicide attempt, or current suicidal ideation c) Current or past (within the last 2 years) alcohol or drug abuse 6. 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) 7. Known inability to undergo an MRI scan 8. Contraindications to the use of glucose 5% infusion 9. Inability to follow study instructions, or complete study assessments, as defined by the protocol 10. 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 11. Legal incapacity or limited legal capacity 12. Pregnant or breastfeeding women 13. History of, or positive serology for viral hepatitis B not explained by vaccination 14. History of, or positive serology for viral hepatitis C or human immunodeficiency virus (HIV) at any time 15. Abnormal liver function tests: AST or ALT > 2 times upper limit of normal range (ULN), or conjugated bilirubin > 2 times ULN, or AP or GGT > 3 times ULN 16. Positive pregnancy test at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of temelimab following intravenous (IV) administration of 18 mg/kg, 36 mg/kg or 54 mg/kg, in patients with RMS who have been treated with rituximab for at least 1 year;Secondary Objective: To determine the pharmacodynamic effects of temelimab on neuroprotection and remyelination based on neuroimaging .;Primary end point(s): • Overall Summary of Adverse Events • AEs by Primary SOC and PT • SAE by Primary SOC and PT • Physical Examination: Shift from Baseline to worst post-dose result by Body System • ECG Interpretation: Change from Baseline to Week 48 and Summary Statistics for change from Baseline to Week 48 • Vital Signs: Summary Statistics For Change From Baseline By Follow-Up Visit • Concomitant Medications by WHO ATC Level Class 1 and WHO ATC Level Class 2 • Hematology: Normal Range Shifts from Baseline by Follow-Up visit • Clinical Chemistry (including C-reactive protein): Normal Range Shifts from Baseline by Follow-Up Visit -Safety Set • Coagulation: Normal Range Shifts from Baseline by Follow-Up Visit -Safety Set • Urinalysis: Normal Range Shifts from Baseline by Follow-Up Visit;Timepoint(s) of evaluation of this end point: Over 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in magnetization transfer (MTR) in periventricular normal-appearing white matter (NAWM) at week 48 compared to baseline • Change in magnetization transfer (MTR) in cerebral cortex at week 48 compared to baseline • Change in T1 lesion volume at week 48 compared to baseline • Change in T2 lesion volume at week 48 compared to baseline • Change in brain parenchymal volume fraction at week 48 compared to baseline • Change in thalamic volume fraction at week 48 compared to baseline ;Timepoint(s) of evaluation of this end point: at week 48 | — |
Countries
Sweden
Contacts
Public ContactClinical Trials Information
GeNeuro Innovation SAS
Outcome results
None listed