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

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ClinicalTrials.gov Identifier: NCT01874340
Recruitment Status : Terminated (Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients)
First Posted : June 11, 2013
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 28, 2013
First Posted Date  ICMJE June 11, 2013
Results First Submitted Date  ICMJE April 13, 2015
Results First Posted Date  ICMJE June 1, 2015
Last Update Posted Date June 1, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions [ Time Frame: Months 3, 4, 5, 6 ]
Primary endpoint is the cumulative number of new Gd-enhancing T1-weighted lesions seen on brain MRI scans obtained at Months 3, 4, 5 and 6.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • Annualized Relapse Rate [ Time Frame: 6 Months ]
    Due to early termination this trial was not powered for efficacy no statistical analysis was performed
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • Annualized Relapse Rate [ Time Frame: 6 Months ]
    Annualized relapse rate is total number of relapses divided by total number of days on study, multiplied by 365.25 to obtain the annual rate.
  • Combined Unique Active Lesions (CUAL) [ Time Frame: Months 3, 4, 5, 6 ]
    New Gd-enhancing T1-weighted lesions or new/enlarging T2-weighted lesions avoiding double counting.
  • Change in Total Volume of T2-weighted Lesions [ Time Frame: Baseline, Month 6 ]
    Mean change in total volume of T2-weighted lesions at Month 6.
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline to Month 6 ]
    All AE/SAE will be reported in safety section of record.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
Official Title  ICMJE 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
Brief Summary To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Placebo
    Placebo will be administered at predefined visits over the 6-month treatment phase.
  • Drug: AIN457
    AIN457 will be administered at predefined visits over the 6-month treatment phase.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: AIN457
  • 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).
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: AIN457
  • 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.
    Intervention: Drug: AIN457
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 1, 2014)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2013)
380
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   France,   Italy,   Japan,   Poland,   Russian Federation,   Spain,   Sweden,   Turkey
Removed Location Countries Canada,   Finland,   Germany,   Romania,   Switzerland,   United States
 
Administrative Information
NCT Number  ICMJE NCT01874340
Other Study ID Numbers  ICMJE CAIN457B2203
2012-004019-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP