Trial Outcomes & Findings for Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis (NCT NCT01874340)
NCT ID: NCT01874340
Last Updated: 2015-06-01
Results Overview
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Months 3, 4, 5, 6
Results posted on
2015-06-01
Participant Flow
Participant milestones
| Measure |
AIN457 15 mg/kg
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 7 mg/kg
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 3 mg/kg
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
Placebo
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
8
|
5
|
Reasons for withdrawal
| Measure |
AIN457 15 mg/kg
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 7 mg/kg
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 3 mg/kg
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
Placebo
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
|---|---|---|---|---|
|
Overall Study
Study terminated by Sponsor
|
6
|
8
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
AIN457 15 mg/kg
n=6 Participants
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 7 mg/kg
n=8 Participants
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 3 mg/kg
n=8 Participants
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
Placebo
n=6 Participants
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.8 Years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
34.5 Years
STANDARD_DEVIATION 8.64 • n=7 Participants
|
35.5 Years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
34.0 Years
STANDARD_DEVIATION 9.30 • n=4 Participants
|
33.5 Years
STANDARD_DEVIATION 8.79 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Months 3, 4, 5, 6Population: 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.
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsPopulation: 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.
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Months 3, 4, 5, 6Population: 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.
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Number of particpants with Adverse events as a measure of safety and tolerability
Outcome measures
| Measure |
AIN457 15 mg/kg
n=6 Participants
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 7 mg/kg
n=8 Participants
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 3 mg/kg
n=8 Participants
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
Placebo
n=6 Participants
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
|---|---|---|---|---|
|
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Adverse Events (AE)
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Non-Fatal Seriuos Aderse Event (SAE)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
AIN457 15 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AIN457 7 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
AIN457 3 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 15 mg/kg
n=6 participants at risk
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 7 mg/kg
n=8 participants at risk
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 3 mg/kg
n=8 participants at risk
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
Placebo
n=6 participants at risk
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
Other adverse events
| Measure |
AIN457 15 mg/kg
n=6 participants at risk
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 7 mg/kg
n=8 participants at risk
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
AIN457 3 mg/kg
n=8 participants at risk
AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
Placebo
n=6 participants at risk
Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
16.7%
1/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Investigations
White blood cell count increased
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
12.5%
1/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
16.7%
1/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
0.00%
0/8
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
16.7%
1/6
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER