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

May 14, 2015 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Novartis Investigative Site
  • Czech Republic
      • JIhlava, Czech Republic, 586 33
        • Novartis Investigative Site
  • France
      • St Herblain, France, 44800
        • Novartis Investigative Site
  • Italy
    • RM
      • Roma, RM, Italy, 00133
        • Novartis Investigative Site
  • Japan
    • Osaka
      • Osaka-city, Osaka, Japan, 556-0016
        • Novartis Investigative Site
  • Poland
      • Lodz, Poland, 93-121
        • Novartis Investigative Site
      • Poznan, Poland, 60-355
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 127018
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 194044
        • Novartis Investigative Site
  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48013
        • Novartis Investigative Site
  • Sweden
      • Stockholm, Sweden, 17176
        • Novartis Investigative Site
  • Turkey
      • Atakum / Samsun, Turkey, 55139
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIN457 low dose
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.
Drug: AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.
Placebo Comparator: Placebo
Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).
Drug: Placebo
Placebo will be administered at predefined visits over the 6-month treatment phase.
Experimental: AIN457 middle dose
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
Drug: AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.
Experimental: AIN457 high dose
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.
Drug: AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457B2203
  • 2012-004019-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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