Multiple Sclerosis
Conditions
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
Brief summary
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
Interventions
DRUGPlacebo
Placebo will be administered at predefined visits over the 6-month treatment phase.
DRUGAIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions | Months 3, 4, 5, 6 | Due to early termination this trial was not powered for efficacy no statistical analysis was performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Relapse Rate | 6 Months | Due to early termination this trial was not powered for efficacy no statistical analysis was performed |
| Combined Unique Active Lesions (CUAL) | Months 3, 4, 5, 6 | Due to early termination this trial was not powered for efficacy no statistical analysis was performed |
| Change in Total Volume of T2-weighted Lesions | Baseline, Month 6 | 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 | 6 months | Number of particpants with Adverse events as a measure of safety and tolerability |
Countries
Belgium, Czechia, France, Italy, Japan, Poland, Russia, Spain, Sweden, Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIN457 15 mg/kg AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. | 6 |
| AIN457 7 mg/kg AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. | 8 |
| AIN457 3 mg/kg AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. | 8 |
| Placebo Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. | 6 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Study terminated by Sponsor | 6 | 8 | 8 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | AIN457 15 mg/kg | AIN457 7 mg/kg | AIN457 3 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 28.8 Years STANDARD_DEVIATION 7.73 | 34.5 Years STANDARD_DEVIATION 8.64 | 35.5 Years STANDARD_DEVIATION 9.71 | 34.0 Years STANDARD_DEVIATION 9.3 | 33.5 Years STANDARD_DEVIATION 8.79 |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 6 | 3 / 8 | 3 / 8 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 1 / 8 | 0 / 8 | 0 / 6 |
Outcome results
Primary
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
Time frame: Months 3, 4, 5, 6
Population: 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.
Secondary
Annualized Relapse Rate
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time frame: 6 Months
Population: 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.
Secondary
Change in Total Volume of T2-weighted Lesions
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time frame: Baseline, Month 6
Population: 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.
Secondary
Combined Unique Active Lesions (CUAL)
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
Time frame: Months 3, 4, 5, 6
Population: 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.
Secondary
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
Time frame: 6 months
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 15 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Adverse Events (AE) | 1 Participants |
| AIN457 15 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Non-Fatal Seriuos Aderse Event (SAE) | 0 Participants |
| AIN457 15 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Death | 0 Participants |
| AIN457 7 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Adverse Events (AE) | 3 Participants |
| AIN457 7 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Non-Fatal Seriuos Aderse Event (SAE) | 1 Participants |
| AIN457 7 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Death | 0 Participants |
| AIN457 3 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Death | 0 Participants |
| AIN457 3 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Adverse Events (AE) | 3 Participants |
| AIN457 3 mg/kg | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Non-Fatal Seriuos Aderse Event (SAE) | 0 Participants |
| Placebo | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Adverse Events (AE) | 2 Participants |
| Placebo | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Non-Fatal Seriuos Aderse Event (SAE) | 0 Participants |
| Placebo | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Death | 0 Participants |