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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01874340

CAIN457B2203

2012-004019-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 4 patient groups, including a placebo group

AIN457 low dose

Experimental group

Description:

AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.

Treatment:

Drug: AIN457

Placebo

Placebo Comparator group

Description:

Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).

Treatment:

Drug: Placebo

AIN457 middle dose

Experimental group

Description:

AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis

Treatment:

Drug: AIN457

AIN457 high dose

Experimental group

Description:

AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.

Treatment:

Drug: AIN457