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

Phase 2TerminatedNCT01874340

Novartis Pharmaceuticals28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

PlaceboDRUG

Placebo will be administered at predefined visits over the 6-month treatment phase.

AIN457DRUG

AIN457 will be administered at predefined visits over the 6-month treatment phase.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (13)

Novartis Investigative Site

Bruges, Belgium

Novartis Investigative Site

Jihlava, Czechia

Novartis Investigative Site

Saint-Herblain, France

Outcomes

Primary Outcomes

Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions

Due to early termination this trial was not powered for efficacy no statistical analysis was performed

Time frame: Months 3, 4, 5, 6

Secondary Outcomes

Annualized Relapse Rate

Due to early termination this trial was not powered for efficacy no statistical analysis was performed

Time frame: 6 Months

Combined Unique Active Lesions (CUAL)

Due to early termination this trial was not powered for efficacy no statistical analysis was performed

Time frame: Months 3, 4, 5, 6

Change in Total Volume of T2-weighted Lesions

Due to early termination this trial was not powered for efficacy no statistical analysis was performed

Time frame: Baseline, Month 6

Number of Particpants With Adverse Events as a Measure of Safety and Tolerability

Number of particpants with Adverse events as a measure of safety and tolerability

Time frame: 6 months

Data from ClinicalTrials.gov

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