Multiple SclerosisPhase 2NCT01874340
Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
A Phase 2 study testing AIN457 in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 13 sites in 10 countries.
Trial summary
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis. 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?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 13 sitesin 10 countries
- Study dates
- Jun 2013to Apr 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
- Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria
- Disease duration of 10 years or less
- At least one relapse in the last year
- EDSS score 0 to 5.0 at entry
Who cannot join
- Active chronic disease of the immune system other than multiple sclerosis
- History of malignancy within the past 5 years
- Active systemic bacterial, viral or fungal infections
- Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)
- Any medically unstable condition
- Unable to undergo MRI scans or repeated blood tests
Show all 9Show fewer
- Pregnant or nursing females
- Women of child-bearing potential must use reliable forms of contraception
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
13 sites in 10 countries.
13 sites in 10 countries
Poland2 sites
Novartis Investigative Site
Lodz, 93-121
Novartis Investigative Site
Poznan, 60-355
Russia2 sites
Novartis Investigative Site
Moscow, 127018
Novartis Investigative Site
Saint Petersburg, 194044
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Bilbao, Basque Country, 48013
Turkey (Türkiye)1 site
Novartis Investigative Site
Atakum / Samsun, 55139
About this study
Official title: A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Placebo, AIN457
- Keywords
- Multiple Sclerosis, Relapsing Multiple Sclerosis, AIN457, Secukinumab, Magnetic Resonance Imaging, Relapsing Remitting Multiple Sclerosis, Autoimmune Diseases, Nervous System Diseases, Immune System Diseases, Demyelinating Diseases
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Autoimmune Diseases, Nervous System Diseases, Immune System Diseases, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be administered at predefined visits over the 6-month treatment phase.
AIN457Drug
AIN457 will be administered at predefined visits over the 6-month treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| AIN457 low dose | Experimental | AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. Receives: Drug: AIN457 |
| Placebo | Placebo comparator | Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2). Receives: Drug: Placebo |
| AIN457 middle dose | Experimental | AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis Receives: Drug: AIN457 |
| AIN457 high dose | Experimental | AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. Receives: Drug: AIN457 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Measured: Months 3, 4, 5, 6
Secondary outcomes (4)
Annualized Relapse Rate
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Measured: 6 Months
Combined Unique Active Lesions (CUAL)
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Measured: Months 3, 4, 5, 6
Change in Total Volume of T2-weighted Lesions
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Measured: Baseline, Month 6
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Number of particpants with Adverse events as a measure of safety and tolerability
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874340
- Sponsor's protocol ID
- CAIN457B2203
- Other IDs
- 2012-004019-29
- Status last verified
- May 2015
- First submitted
- 28 May 2013
- Last updated
- 1 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01874340
- Acronym / sponsor ID
- CAIN457B2203
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Relapsing Multiple Sclerosis, AIN457, Secukinumab, Magnetic Resonance Imaging, Relapsing Remitting Multiple Sclerosis, Autoimmune Diseases, Nervous System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AIN457 low dose | Experimental | Drug: AIN457AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2). |
| AIN457 middle dose | Experimental | Drug: AIN457AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis |
| AIN457 high dose | Experimental | Drug: AIN457AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria
- Disease duration of 10 years or less
- At least one relapse in the last year
- EDSS score 0 to 5.0 at entry
Key exclusion criteria (9 listed)
- Active chronic disease of the immune system other than multiple sclerosis
- History of malignancy within the past 5 years
- Active systemic bacterial, viral or fungal infections
- Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)
- Any medically unstable condition
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 |
|---|---|---|
| PlaceboPlacebo will be administered at predefined visits over the 6-month treatment phase. | Drug | Placebo |
| AIN457AIN457 will be administered at predefined visits over the 6-month treatment phase. | Drug | AIN457 high dose, AIN457 low dose, AIN457 middle dose |
Primary outcome
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
Time frame: Months 3, 4, 5, 6
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
4 secondary outcomes
Annualized Relapse Rate
Time frame: 6 Months
Combined Unique Active Lesions (CUAL)
Time frame: Months 3, 4, 5, 6
Change in Total Volume of T2-weighted Lesions
Time frame: Baseline, Month 6
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
13 sites in 10 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 13 sites in 10 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland, Russia, Spain, Belgium, Czechia and 5 more countries. 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. Some participants in this study may receive a placebo. 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 1 Jun 2015). 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?
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions (time frame: Months 3, 4, 5, 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2015.