Multiple SclerosisPhase 2NCT01433250

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

A Phase 2 study testing AIN457 in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: AIN457
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 14 sitesin 3 countries
Study dates: Feb 2012to Jun 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

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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.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

Czechia5 sites

Novartis Investigative Site
Hradec Králové, Czech Republic, 500 05
Novartis Investigative Site
Ostrava
Novartis Investigative Site
Ostrava-Moravska Ostrava
Novartis Investigative Site
Prague, 128 08
Novartis Investigative Site
Teplice, 415 29

Other trials in Czechia

Ukraine5 sites

Novartis Investigative Site
Kharkiv, 61068
Novartis Investigative Site
Kharkiv
Novartis Investigative Site
Kiev
Novartis Investigative Site
Odesa, 65025
Novartis Investigative Site
Vinnitsya, 21005

Other trials in Ukraine

Russia4 sites

Novartis Investigative Site
Kazan', 420021
Novartis Investigative Site
Moscow, 129128
Novartis Investigative Site
Nizhny Novgorod, 603155
Novartis Investigative Site
Smolensk, 214019

Other trials in Russia

About this study

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

Conditions: Multiple Sclerosis
Being tested: AIN457
Keywords: Multiple Sclerosis,, demyelinating autoimmune diseases,, interleukin-17,, monoclonal human antibody
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AIN457Drug
Also called AIN457 core/ AIN extension
(10mg/kg i.v.).
AIN457Drug
Also called AIN Placebo / AIN Extension
(10mg/kg i.v.).

Study groups in NCT01433250
Study group	Role	What they receive
AIN 457 Core	Experimental	(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension Receives: Drug: AIN457
AIN457 Placebo Core	Experimental	(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension Receives: Drug: AIN457

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 97 weeks

Secondary outcomes (5)

Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
Description: number of relapses based on neurological assessments and EDSS
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline to week 97

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2014

First posted13 Sep 2011 (estimated)
Study startFeb 2012
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01433250
Sponsor's protocol ID: CAIN457B2201E1
Other IDs: 2011-001629-25
Status last verified: Feb 2016
First submitted: 26 Aug 2011
Last updated: 14 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
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RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
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RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT01433250
Acronym / sponsor ID: CAIN457B2201E1
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis,, demyelinating autoimmune diseases,, interleukin-17,, monoclonal human antibody
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 13 Sep 2011 (estimated)
Results: Posted 14 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AIN 457 Core	Experimental	Drug: AIN457(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension
AIN457 Placebo Core	Experimental	Drug: AIN457(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (15 listed)

Have been treated with:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AIN457Also: AIN457 core/ AIN extension(10mg/kg i.v.).	Drug	AIN 457 Core
AIN457Also: AIN Placebo / AIN Extension(10mg/kg i.v.).	Drug	AIN457 Placebo Core

Primary outcome

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

5 secondary outcomes

Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
Time frame: week 97
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
Time frame: weeks 13,25,37,53,73 and 97
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
Time frame: weeks 13,25,37,53,73 and 97
Change in Brain Volume at End of Study.
Time frame: week 97
Measure of Disability: Expanded Disability Status Scale (EDSS).
Time frame: Baseline to week 97

Results and safety

Results posted to the registry on 14 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIN457 Core / AIN457 Extension	22	19
AIN Placebo/ AIN457 Extension	17	14

Primary outcome: Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments

Time frame: 97 weeks. Number. Unit: participants

Measure	AIN/AIN n = 22	PBO/AIN n = 17
Value	12	8

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo(Core)/AIN457(Extension)	0 of 17 (0%)	8 of 17 (47.1%)	Not reported
AIN457(Core)/AIN457(Extension)	2 of 22 (9.1%)	7 of 22 (31.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Multiple Sclerosis

Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AIN457 in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Czechia, Ukraine, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments (time frame: 97 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01433250.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.