A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: AIN457

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czech Republic
  • Hradec Kralove, Czech Republic, 500 05
    • Novartis Investigative Site
  • Ostrava, Czech Republic
    • Novartis Investigative Site
  • Ostrava-Moravska Ostrava, Czech Republic
    • Novartis Investigative Site
  • Praha 2, Czech Republic, 128 08
    • Novartis Investigative Site
  • Teplice, Czech Republic, 415 29
    • Novartis Investigative Site
• Russian Federation
  • Kazan, Russian Federation, 420021
    • Novartis Investigative Site
  • Moscow, Russian Federation, 129128
    • Novartis Investigative Site
  • Nizhny Novgorod, Russian Federation, 603155
    • Novartis Investigative Site
  • Smolensk, Russian Federation, 214019
    • Novartis Investigative Site
• Ukraine
  • Kharkiv, Ukraine, 61068
    • Novartis Investigative Site
  • Kharkiv, Ukraine
    • Novartis Investigative Site
  • Kiev, Ukraine
    • Novartis Investigative Site
  • Odessa, Ukraine, 65025
    • Novartis Investigative Site
  • Vinnitsya, Ukraine, 21005
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201 study, up to at and including Visit 10 (week 24).

Exclusion Criteria:

1. Have been treated with:

   • immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal.
   • immunoglobulins and/or monoclonal antibodies (with the exception of AIN457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of B cell depletion after rituximab treatment).
2. Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects.
3. Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
4. A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome.
5. Current severe depression.
6. Pregnant or nursing (lactating) women.
7. Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
8. A new diagnosis of diabetes
9. Positive testing for tuberculosis (QuantiFeron or chest X-ray).
10. Subjects with clinically significant cardiac abnormalities
11. Unable or unwilling to undergo multiple venipunctures
12. Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIN 457 Core; (10mg/kg i.v.). AIN 457 core study /AIN 457 Extension	Drug: AIN457; (10mg/kg i.v.).; Other Names: AIN Placebo / AIN Extension
Experimental: AIN457 Placebo Core; (10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension	Drug: AIN457; (10mg/kg i.v.).; Other Names: AIN Placebo / AIN Extension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments	Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome	97 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)	Description: number of relapses based on neurological assessments and EDSS	week 97
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI	Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans	weeks 13,25,37,53,73 and 97
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI	Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions	weeks 13,25,37,53,73 and 97
Change in Brain Volume at End of Study.	Change in volume from start to end of study	week 97
Measure of Disability: Expanded Disability Status Scale (EDSS).	The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.	Baseline to week 97

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: September 9, 2011
• First Posted (Estimate): September 13, 2011

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Multiple Sclerosis,; demyelinating autoimmune diseases,; interleukin-17,; monoclonal human antibody
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CAIN457B2201E1; 2011-001629-25 (EudraCT Number)