Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis
- Conditions
- Multiple Sclerosis (MS)MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004059-29-HR
- Lead Sponsor
- GeNeuro SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
- 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 < 6.0
- Patient (male or female with reproductive potential) who agree to use a highly effective method of birth control.
-Other criteria as stated in study protocol
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 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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-DC 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>- To evaluate GNbAC1 effect on remyelination in new gadolinium enhancing and T2 lesions <br>- To evaluate the safety and tolerability of repeated doses of GNbAC1<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - Cumulative T2 lesions and CUAL. <br>- Change from baseline (SD1) in T1 and T2 lesion load (T1 and T2 burden of disease) <br>- Relapse (time to first relapse; relapse rate; percentage of patients free of relapse)<br>- Adverse events (AEs) and serious adverse events (SAEs) <br>- 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<br>-Relapse: Week 24 and Week 48<br>-AEs, SAEs: entire study <br>-PK: on Days 85, 169, 253 and 337