Multiple Sclerosis (MS) MedDRA version: 19.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
GeNeuro SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of relapsing remitting multiple sclerosis according to Mc Donald criteria (2010) - Evidence of recent disease activity: 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; - Body weight > 40 kg and = 100 kg; - EDSS score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients suffering from secondary progressive MS (SPMS) or primary progressive MS (PPMS); - Any disease other than MS that could better explain signs and symptoms; - Complete transverse myelitis or bilateral optic neuritis; - Patients who have been treated with: oral or systemic corticosteroids, or adrenocorticotropic hormone (ACTH), within 30 days prior to selection ; interferon beta or glatiramer acetate, intravenous immunoglobulin (IVIG), natalizumab, dimethylfumarate, teriflunomide, laquinimod or fingolimod in the last 3 months prior to selection ; mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, cytotoxic or immunosuppressive therapy (excluding systemic steroid and ACTH), total lymphoid irradiation or bone marrow transplantation at any time ; any cytokine (other than interferon), B cell modulating therapy such as anti-CD 20 antibodies like ocrelizumab, ofatumumab or rituximab, or daclizumab (anti-CD 25 antibody) or anti-cytokine therapy, plasmapheresis or azathioprine in the last 6 months prior to selection ; ongoing treatment with an experimental drug; preceding treatment with another experimental drug if not washed out for = 5 halflives or = 3 months (whichever is longer); - CTCAE Grade 2 or greater lymphopenia following treatment with an immunosuppressor or immunomodulator; - Any major medical or psychiatric disorder - History or presence of serious or acute heart disease - Known inability to undergo an MRI scan - positive serology for hepatitis B/C , HIV - abnormal liver function tests (ASAT, ALAT, Total bilirubin >2ULN; AP >3 ULN) - Moderate to Severe Renal impairment - positive pregnancy test - other criteria as stated in the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of repeated doses of GNbAC1 in patients with MS based on the cumulative number of gadolinium (Gd)-enhancing T1 lesions on brain MRI vs. placebo.;Secondary Objective: - To evaluate the effect of GNbAC1 on other parameters of disease activity - To evaluate the safety and tolerability of repeated doses of GNbAC1 - To evaluate pharmacokinetics of repeated doses of GNbAC1;Primary end point(s): Cumulative number of Gd-enhancing T1 lesions measured using repeated MRI assessments from Week 12 to 24. ;Timepoint(s) of evaluation of this end point: From Week 12 to 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Cumulative T2 lesions and CUAL. - Change from baseline (SD1) in T1 and T2 lesion load (T1 and T2 burden of disease) - Relapse (time to first relapse; relapse rate; percentage of patients free of relapse) - Adverse events (AEs) and serious adverse events (SAEs) - Pharmacokinetics (PK) of repeated doses of GNbAC1;Timepoint(s) of evaluation of this end point: -MRI scan: SD1, Week 12, Week 16, Week 20, Week 24, Week 48 -Relapse: Week 24 and Week 48 -AEs, SAEs: entire study -PK: on Days 85, 169, 253 and 337 | — |
Countries
Bulgaria, Croatia, Czech Republic, Estonia, France, Germany, Hungary, Italy, Poland, Russian Federation, Serbia, Spain, Ukraine
Contacts
Public ContactProject Management
Worldwide Clinical Trials Ltd
Outcome results
None listed