Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria

• Disease duration of 10 years or less

• At least one relapse in the last year

• EDSS score 0 to 5.0 at entry

Exclusion Criteria:

• Active chronic disease of the immune system other than multiple sclerosis

• History of malignancy within the past 5 years

• Active systemic bacterial, viral or fungal infections

• Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)

• Any medically unstable condition

• Unable to undergo MRI scans or repeated blood tests

• Pregnant or nursing females

• Women of child-bearing potential must use reliable forms of contraception

• Other protocol-defined inclusion/exclusion criteria may apply.