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

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: AIN457

• Registration Number: NCT01433250
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-13
• Study Start: 2012-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-05-28
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Results First Posted: 2016-03-14
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIN 457 Core	AIN457	(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension
AIN457 Placebo Core	AIN457	(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)	week 97	Description: number of relapses based on neurological assessments and EDSS
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI	weeks 13,25,37,53,73 and 97	Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T1-weighted scans
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI	weeks 13,25,37,53,73 and 97	Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T2-weighted lesions
Change in Brain Volume at End of Study.	week 97	Change in volume from start to end of study
Measure of Disability: Expanded Disability Status Scale (EDSS).	Baseline to week 97	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇦 Vinnitsya, Ukraine