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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01874340
First received: May 28, 2013
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Placebo
Drug: AIN457
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Cumulative number of new Gadolinium [Gd]-enhancing T1-weighted lesions [ Time Frame: Months 3, 4, 5, 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Annualized relapse rate [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    All AE/SAE will be reported in safety section of record.


Estimated Enrollment: 380
Study Start Date: June 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874340

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 87 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01874340     History of Changes
Other Study ID Numbers: CAIN457B2203, 2012-004019-29
Study First Received: May 28, 2013
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: ANSM: National Agency for the Safety of Medicine
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Turkish Republic Ministry of Health, Turkish Pharmaceuticals and Medical Devices Agency
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Portugal: Instituto Nacional de Farmacia e do Medicamento (INFARMED)
Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
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:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014