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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016807-42 |
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The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 1x25mg | Experimental |
| |
| AIN457 3x25mg | Experimental |
| |
| AIN457 3x75mg | Experimental |
| |
| AIN457 3x150mg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). | week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Response | IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline. | Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 |
| Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) |
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Inclusion Criteria:
Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
At randomization, moderate to severe psoriasis as defined by:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | San Diego | California | 92123 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Click here for more information about this study: | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 1x25mg | AIN457 25mg Subcutaneously as a single dose |
| FG001 | AIN457 3x25mg | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
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PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). |
| Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 |
| To Assess the Time to Relapse | Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups. | 37 weeks |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Novartis Investigative Site | Rochester | New York | 14623 | United States |
| Novartis Investigative Site | Lake Oswego | Oregon | 97035 | United States |
| Novartis Investigative Site | Portland | Oregon | 97210 | United States |
| Novartis Investigative Site | Halifax | Nova Scotia | B3H 1Z2 | Canada |
| Novartis Investigative Site | North Bay | Ontario | P1B 3Z7 | Canada |
| Novartis Investigative Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Novartis Investigative Site | Tallinn | Estonia | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Kopavogur | IS-201 | Iceland |
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371-8511 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-0063 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 330-0854 | Japan |
| Novartis Investigative Site | Riga | 1012 | Latvia |
| Novartis Investigative Site | Riga | LV-1001 | Latvia |
| Novartis Investigative Site | Riga | Latvia |
| FG002 | AIN457 3x75mg | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| FG003 | AIN457 3x150mg | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| FG004 | Placebo | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 1x25mg | AIN457 25mg Subcutaneously as a single dose |
| BG001 | AIN457 3x25mg | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| BG002 | AIN457 3x75mg | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| BG003 | AIN457 3x150mg | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| BG004 | Placebo | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). | The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. | Posted | Number | percentage of participants | week 13 |
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| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Response | IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline. | The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. | Posted | Number | percentage of participants | Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 |
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| Secondary | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). | The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. | Posted | Number | Percentage of Participants | Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 |
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| Secondary | To Assess the Time to Relapse | Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups. | The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. | Posted | Median | 95% Confidence Interval | days | 37 weeks |
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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 1x25mg | AIN457 25mg Subcutaneously as a single dose | 0 | 29 | 14 | 29 | ||
| EG001 | AIN457 3x25mg | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 2 | 26 | 11 | 26 | ||
| EG002 | AIN457 3x75mg | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 1 | 21 | 10 | 21 | ||
| EG003 | AIN457 3x150mg | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 0 | 27 | 16 | 27 | ||
| EG004 | Placebo | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 2 | 22 | 8 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does 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 trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Male |
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| Placebo |
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
|
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| OG003 | AIN457 3x150mg | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| OG004 | Placebo | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
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| Units | Counts |
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| Participants |
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