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

NCT01433250 | Completed Phase 2 Results

• 2 other identifiers: CAIN457B2201E12011-001629-25
• Study Type: interventional
• Target: 39
• Locations: 3 countries
• Sites: 14

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis,; demyelinating autoimmune diseases,; interleukin-17,; monoclonal human antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)

  week 97

• Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI

  weeks 13,25,37,53,73 and 97

• Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI

  weeks 13,25,37,53,73 and 97

• Change in Brain Volume at End of Study.

  week 97

• Measure of Disability: Expanded Disability Status Scale (EDSS).

  Baseline to week 97

Study Arms (2)

AIN 457 Core

EXPERIMENTAL

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

Drug: AIN457

AIN457 Placebo Core

EXPERIMENTAL

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

Drug: AIN457

Interventions

AIN457 DRUG

(10mg/kg i.v.).

Also known as: AIN457 core/ AIN extension

AIN 457 Core

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).
• 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.
• Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
• A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome.
• Current severe depression.
• Pregnant or nursing (lactating) women.
• Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
• A new diagnosis of diabetes
• Positive testing for tuberculosis (QuantiFeron or chest X-ray).
• Subjects with clinically significant cardiac abnormalities
• Unable or unwilling to undergo multiple venipunctures
• Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

Novartis Investigative Site

Hradec Králové, Czech Republic, 500 05, Czechia

Location

Novartis Investigative Site

Ostrava, Czechia

Location

Novartis Investigative Site

Ostrava-Moravska Ostrava, Czechia

Location

Novartis Investigative Site

Prague, 128 08, Czechia

Location

Novartis Investigative Site

Teplice, 415 29, Czechia

Location

Novartis Investigative Site

Kazan', 420021, Russia

Location

Novartis Investigative Site

Moscow, 129128, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603155, Russia

Location

Novartis Investigative Site

Smolensk, 214019, Russia

Location

Novartis Investigative Site

Kharkiv, 61068, Ukraine

Location

Novartis Investigative Site

Kharkiv, Ukraine

Location

Novartis Investigative Site

Kiev, Ukraine

Location

Novartis Investigative Site

Odesa, 65025, Ukraine

Location

Novartis Investigative Site

Vinnitsya, 21005, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Further development of secukinumab in MS is not being pursued and the extension study , CAIN457B2201E1, further enrollment stopped . Not completing enrollment of this study was not related to the safety or tolerability concerns observed in the study.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: September 13, 2011
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

UA (5); RU (4); CZ (5)