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

Status:	Completed
Conditions:	Neurology, Multiple Sclerosis
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	18 - 55
Updated:	5/5/2014
Start Date:	June 2013
End Date:	October 2015
Contact:	Novartis Pharmaceuticals
Phone:	1-888-669-6682

A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

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

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.

We found this trial at

sites

Novartis

Portland, Oregon 97228