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

A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004019-29-BE

Enrollment

380

Registered

2012-10-23

Start date

2013-04-29

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing multiple sclerosis MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for infusion CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Other descriptive name: SECUKINUMAB Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 class of multiple sclerosis disease-modifying therapy - Patients who have been treated with: Interferon-beta or glatiramer acetate within 1 month prior to randomization; Natalizumab within 6 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

Design outcomes

Primary

Measure	Time frame
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 3 doses of AIN457;Primary end point(s): To define the efficacy of AIN457, relative to placebo, in reducing the cumulative number of new Gadolinium-enhancing T1-weighted lesions recorded on all available MRI scans;Timepoint(s) of evaluation of this end point: At months 3, 4, 5 and 6	—

Measure

Time frame

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 3 doses of AIN457;Primary end point(s): To define the efficacy of AIN457, relative to placebo, in reducing the cumulative number of new Gadolinium-enhancing T1-weighted lesions recorded on all available MRI scans;Timepoint(s) of evaluation of this end point: At months 3, 4, 5 and 6

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Secondary

Measure	Time frame
Secondary end point(s): - To evaluate the safety and tolerability of three 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	—

Measure

Time frame

Secondary end point(s): - To evaluate the safety and tolerability of three 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

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Countries

Argentina, Belgium, Canada, Colombia, Czech Republic, Finland, France, Germany, Italy, Japan, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, Turkey, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026