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Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01874340
Recruitment Status : Terminated (Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients)
First Posted : June 11, 2013
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Placebo
Drug: AIN457
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Period Title: Overall Study
Started 6 8 8 6
Completed 0 0 0 1
Not Completed 6 8 8 5
Reason Not Completed
Study terminated by Sponsor             6             8             8             4
Withdrawal by Subject             0             0             0             1
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo Total
Hide Arm/Group Description AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. Total of all reporting groups
Overall Number of Baseline Participants 6 8 8 6 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 8 participants 6 participants 28 participants
28.8  (7.73) 34.5  (8.64) 35.5  (9.71) 34.0  (9.30) 33.5  (8.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 8 participants 6 participants 28 participants
Female
4
  66.7%
4
  50.0%
6
  75.0%
4
  66.7%
18
  64.3%
Male
2
  33.3%
4
  50.0%
2
  25.0%
2
  33.3%
10
  35.7%
1.Primary Outcome
Title Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
Hide Description Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame Months 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description:
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Annualized Relapse Rate
Hide Description Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description:
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Combined Unique Active Lesions (CUAL)
Hide Description Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame Months 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description:
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Total Volume of T2-weighted Lesions
Hide Description Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description:
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Hide Description Number of particpants with Adverse events as a measure of safety and tolerability
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set consists of all subjects who received at least one dose of study medication. Subjects will be analyzed according to the treatment received.
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description:
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
Overall Number of Participants Analyzed 6 8 8 6
Measure Type: Number
Unit of Measure: Participants
Adverse Events (AE) 1 3 3 2
Death 0 0 0 0
Non-Fatal Seriuos Aderse Event (SAE) 0 1 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
 
Arm/Group Title AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
All-Cause Mortality
AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/8 (12.50%)   0/8 (0.00%)   0/6 (0.00%) 
Gastrointestinal disorders         
Gastritis  1  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   3/8 (37.50%)   3/8 (37.50%)   2/6 (33.33%) 
Gastrointestinal disorders         
Nausea  1  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/6 (16.67%) 
General disorders         
Pyrexia  1  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/6 (16.67%) 
Infections and infestations         
Nasopharyngitis  1  1/6 (16.67%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Bronchitis  1  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Pharyngitis  1  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/6 (16.67%) 
Tinea versicolour  1  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Vaginal infection  1  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Investigations         
C-reactive protein increased  1  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
White blood cell count increased  1  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Hyperphagia  1  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Back pain  1  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis doesn not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (i.e. data from all sites) in the clinical trial or disclosure of the trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01874340    
Other Study ID Numbers: CAIN457B2203
2012-004019-29 ( EudraCT Number )
First Submitted: May 28, 2013
First Posted: June 11, 2013
Results First Submitted: April 13, 2015
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015