Back to resultsEfficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
AIN457
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Relapsing Multiple Sclerosis, AIN457, Secukinumab, Magnetic Resonance Imaging, Relapsing Remitting Multiple Sclerosis, Autoimmune Diseases, Nervous System Diseases, Immune System Diseases, Demyelinating Diseases
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnant or nursing females
- Women of child-bearing potential must use reliable forms of contraception
- Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
AIN457 low dose
Placebo
AIN457 middle dose
AIN457 high dose
Arm Description
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.
Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Annualized Relapse Rate
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Combined Unique Active Lesions (CUAL)
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Change in Total Volume of T2-weighted Lesions
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01874340
Brief Title
Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIN457 low dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).
Arm Title
AIN457 middle dose
Arm Type
Experimental
Arm Description
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
Arm Title
AIN457 high dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered at predefined visits over the 6-month treatment phase.
Intervention Type
Drug
Intervention Name(s)
AIN457
Intervention Description
AIN457 will be administered at predefined visits over the 6-month treatment phase.
Primary Outcome Measure Information:
Title
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
Description
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame
Months 3, 4, 5, 6
Secondary Outcome Measure Information:
Title
Annualized Relapse Rate
Description
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame
6 Months
Title
Combined Unique Active Lesions (CUAL)
Description
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame
Months 3, 4, 5, 6
Title
Change in Total Volume of T2-weighted Lesions
Description
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame
Baseline, Month 6
Title
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Description
Number of particpants with Adverse events as a measure of safety and tolerability
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnant or nursing females
Women of child-bearing potential must use reliable forms of contraception
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Novartis Investigative Site
City
JIhlava
ZIP/Postal Code
586 33
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
St Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
556-0016
Country
Japan
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
93-121
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Novartis Investigative Site
City
Atakum / Samsun
ZIP/Postal Code
55139
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
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