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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Study Description
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Brief Summary:
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Placebo Drug: AIN457 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Annualized Relapse Rate [ Time Frame: 6 Months ]
    Due to early termination this trial was not powered for efficacy no statistical analysis was performed

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874340


Locations
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Belgium
Novartis Investigative Site
Brugge, Belgium, 8000
Czech Republic
Novartis Investigative Site
JIhlava, Czech Republic, 586 33
France
Novartis Investigative Site
St Herblain, France, 44800
Italy
Novartis Investigative Site
Roma, RM, Italy, 00133
Japan
Novartis Investigative Site
Osaka-city, Osaka, Japan, 556-0016
Poland
Novartis Investigative Site
Lodz, Poland, 93-121
Novartis Investigative Site
Poznan, Poland, 60-355
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 127018
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 194044
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Bilbao, Pais Vasco, Spain, 48013
Sweden
Novartis Investigative Site
Stockholm, Sweden, 17176
Turkey
Novartis Investigative Site
Atakum / Samsun, Turkey, 55139
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01874340    
Other Study ID Numbers: CAIN457B2203
2012-004019-29 ( EudraCT Number )
First Posted: June 11, 2013    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Sclerosis
Relapsing Multiple Sclerosis
AIN457
Secukinumab
Magnetic Resonance Imaging
 Relapsing Remitting Multiple Sclerosis
Autoimmune Diseases
Nervous System Diseases
Immune System Diseases
Demyelinating Diseases
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases