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-CZ
• Lead Sponsor: GeNeuro SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-09
• Last Update Posted: 19 February 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
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

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

Study & Design

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