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

Novartis

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433250

2011-001629-25 (EudraCT Number)

CAIN457B2201E1

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

AIN 457 Core

Experimental group

Description:

(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension

Treatment:

Drug: AIN457

Drug: AIN457

AIN457 Placebo Core

Experimental group

Description:

(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension

Treatment:

Drug: AIN457

Drug: AIN457