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

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: AIN457

• Registration Number: NCT01874340
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-28
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-04-13
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-14
• Last Update Submitted: 2015-05-14
• Results First Posted: 2015-06-01
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).
AIN457 high dose	AIN457	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.
AIN457 middle dose	AIN457	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
AIN457 low dose	AIN457	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.

Primary Outcome Measures

Name	Time	Method
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions	Months 3, 4, 5, 6	Due to early termination this trial was not powered for efficacy no statistical analysis was performed

Secondary Outcome Measures

Name	Time	Method
Annualized Relapse Rate	6 Months	Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Combined Unique Active Lesions (CUAL)	Months 3, 4, 5, 6	Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Change in Total Volume of T2-weighted Lesions	Baseline, Month 6	Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability	6 months	Number of particpants with Adverse events as a measure of safety and tolerability

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Atakum / Samsun, Turkey