Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis

Phase 1

Conditions: relapsing-remitting multiple sclerosis
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-002324-16-CZ

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 96

Inclusion Criteria

-Male and female patients 18 to 55 years of age.
-Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman, et. al. 2011).
-A relapsing-remitting course of disease with:
at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization as per criterion 6), or a positive Gd-enhancing lesion on brain MRI scan at screening.
-An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.
-No evidence of a relapse within 30 days prior to randomization.

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 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-A manifestation of another type of MS other than RRMS.
-Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS.
-History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome.
-Unable to undergo MRI scans due to inter-alia, claustrophobia, incompatible cardiac pacemakers, ferromagnetic intracranial, Aneurysm clips, certain cochlear implants, and certain other ferromagnetic foreign bodies (e.g. tattoos containing metal) or electronic devices, or metallic implants incompatible with MRI.
-Unable to receive gadolinium-based MRI contrast agents due to a history of hypersensitivity to gadolinium-based contrast agents, renal insufficiency or impairment.
-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the course of the study and for 4 months following completion of the study.
-Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, or other immunosuppressive treatments with effects lasting longer than 6 months (wash-out times for other registered or putative immunomodulators or immunosupressants apply)
- Patient may stop their current treatment only if considered not effective, not safe, or not tolerated by HCP and/or patient (for Czech Republic only)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if a monoclonal antibody VAY736 can reduce disease activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo.;Secondary Objective: To evaluate the safety and tolerability of VAY736 in patients with RRMS.<br>To evaluate the effect of VAY736 on additional parameters observed on brain MRI scans including:<br>- Number of all T1-weighted Gd-enhancing lesions<br>- Number of new or enlarging T2-weighted lesions<br>- T2 burden of disease (total volume of T2-weighted lesions)<br>- Proportion of subjects without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions)<br>To evaluate the effect of VAY736 on the number of relapses<br>;Primary end point(s): Cumulative number of new Gd-enhancing lesions.;Timepoint(s) of evaluation of this end point: 8, 12, 16 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 4, 8, 12, 16 weeks;Secondary end point(s): -Number of new and cumulative number of new T1-weighted Gd-enhancing lesions. <br>-Number of all T1-weighted Gd-enhancing lesions.<br>-Cumulative number of new or enlarging T2-weighted Gd-enhancing lesions. <br>-T2 burden of disease<br>-Proportion of subjects without any new MRI disease activity.<br>-The number of confirmed relapses at week 16<br>-Proportion of relapse-free patients over the 16 weeks of the treatment period<br>-Number of patients with adverse events

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