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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004019-29 | EudraCT Number |
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Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients
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To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo will be administered at predefined visits over the 6-month treatment phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Months 3, 4, 5, 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate | Due to early termination this trial was not powered for efficacy no statistical analysis was performed | 6 Months |
| Combined Unique Active Lesions (CUAL) | Due to early termination this trial was not powered for efficacy no statistical analysis was performed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bruges | 8000 | Belgium | |||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 15 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| FG001 | AIN457 7 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| FG002 | AIN457 3 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| FG003 | Placebo | Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 15 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| BG001 | AIN457 7 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Months 3, 4, 5, 6 |
|
Not provided
The safety set consists of all subjects who received at least one dose of study medication. Subjects were analyzed according to the treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIN457 15 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
Due to early termination this trial was not powered for efficacy no statistical analysis was performed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D001327 | Autoimmune Diseases |
| D009422 | Nervous System Diseases |
| D007154 | Immune System Diseases |
| D003711 | Demyelinating Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| AIN457 | Drug | AIN457 will be administered at predefined visits over the 6-month treatment phase. |
|
| 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 | 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 | 6 months |
| Jihlava |
| 586 33 |
| Czechia |
| Novartis Investigative Site | Saint-Herblain | 44800 | France |
| Novartis Investigative Site | Roma | RM | 00133 | Italy |
| Novartis Investigative Site | Osaka | Osaka | 556-0016 | Japan |
| Novartis Investigative Site | Lodz | 93-121 | Poland |
| Novartis Investigative Site | Poznan | 60-355 | Poland |
| Novartis Investigative Site | Moscow | 127018 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194044 | Russia |
| Novartis Investigative Site | Bilbao | Basque Country | 48013 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Stockholm | 17176 | Sweden |
| Novartis Investigative Site | Atakum / Samsun | 55139 | Turkey (Türkiye) |
| Withdrawal by Subject |
|
| BG002 | AIN457 3 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| BG003 | Placebo | Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | AIN457 3 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
| OG003 | Placebo | Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. |
|
| Secondary | Annualized Relapse Rate | Due to early termination this trial was not powered for efficacy no statistical analysis was performed | 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. | Posted | 6 Months |
|
|
| Secondary | Combined Unique Active Lesions (CUAL) | Due to early termination this trial was not powered for efficacy no statistical analysis was performed | 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. | Posted | Months 3, 4, 5, 6 |
|
|
| 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 | 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. | Posted | Baseline, Month 6 |
|
|
| 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 | 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. | Posted | Number | Participants | 6 months |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | AIN457 7 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. | 1 | 8 | 3 | 8 |
| EG002 | AIN457 3 mg/kg | AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. | 0 | 8 | 3 | 8 |
| EG003 | Placebo | Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter. | 0 | 6 | 2 | 6 |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Hyperphagia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
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.
| Death |
|
| Non-Fatal Seriuos Aderse Event (SAE) |
|