Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

Conditions: Relapsing multiple sclerosis
MedDRA version: 14.1Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressiveSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-004019-29-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 470

Inclusion Criteria

- Diagnosis of multiple sclerosis according to published criteria - Evidence of recent disease activity - Disease duration of no more than 10 years - EDSS score of 0 to 5.0
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 470
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with an active chronic disease of the immune system other than multiple sclerosis or with a known immunodeficiency syndrome - History of malignancy - Patients with active infections - Patients who have been previously treated with more than one multiple sclerosis disease-modifying therapy - Patients who have been treated with: Interferon-beta or glatiramer acetate within 1 month prior to randomization; Natalizumab within 3 months prior to randomization; Fingolimod within 3 months prior to randomization; Immunosuppressive medications within 6 months prior to randomization; Rituximab within 2 years prior to randomization; Cyclophosphamide, mitoxantrone, or alemtuzumab at any time; Total white blood cells (WBC) count <2,500/microL, or lymphocytes <800/microL, or neutrophils <1,500/microL; Patients unable to undergo MRI scans, including claustrophobia; Pregnant or breast-feeding females

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of multiple doses of AIN457 in reducing the number of new Gadolinium-enhancing lesions on MRI compared to placebo;Secondary Objective: To evaluate the safety and tolerability of multiple doses of AIN457;Primary end point(s): To define the dose-response efficacy relationship of AIN457, relative to placebo, in reducing the cumulative number of new Gadoliniumenhancing T1-weighted lesions recorded on all available MRI scans;Timepoint(s) of evaluation of this end point: At months 3, 4, 5 and 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - To evaluate the safety and tolerability of multiple doses of AIN457, relative to placebo, in patients with relapsing multiple sclerosis - To evaluate the effect of AIN457, over a range of doses, on other parameters of disease activity as evaluated by MRI - To evaluate the effect of AIN457, over a range of doses, on clinical disease activity as evaluated by annualized relapse rate;Timepoint(s) of evaluation of this end point: At months 0 to 6