Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis

Phase 1

• Conditions: Multiple Sclerosis (MS); MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004059-29-IT
• Lead Sponsor: GENEURO SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-27
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

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 < 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
-Clinical stability for 30 days prior to selection
- Results of physical examination and laboratory tests must be available and free of any clinical significant abnormality likely to interfere with the study conduct or evaluation.

Are the trial subjects under 18? no
Number of subjects for this age range: 1
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

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, 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 such as 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
- patients with contraindications to the use of gadolinium-containing contrast agents or glucose 5% solution for infusion
- 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
- Treatment-naïve patients: patients who have never been treated with a disease modifying treatment
- other criteria as stated in the study protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified