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This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 0.3 mg/kg | Experimental | Participants received AIN457 0.3 mg/kg IV on Day 1. |
|
| AIN457 1.0 mg/kg | Experimental | Participants received AIN457 1.0 mg/kg IV on Day 1. |
|
| AIN457 3.0 mg/kg | Experimental | Participants received AIN457 3.0 mg/kg IV on Day 1. |
|
| Placebo | Placebo Comparator | Participants received placebo to AIN457A IV on day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PASI | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | baseline, weeks 12, 14, 16, 20, 24, 28 and 32 |
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Inclusion Criteria:
Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
Coverage of the body surface area (BSA) of 10% or more with plaques
A score of 3 or more on the IGA (Investigator Global Assessment) scale
A PASI score of at least 12 at baseline;
Exclusion Criteria:
Have forms of psoriasis other than the required "plaque psoriasis"
Women of childbearing potential
Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
Previous treatment with this investigational drug
Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities
Other protocol-defined inclusion/exclusion criteria may have applied.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Santa Monica | California | 90404 | United States | ||
| Novartis Investigative Site |
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A total of 80 participants were enrolled into the study. However, due to audit findings at one site, all 65 participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. The safety set included participants from all other sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 0.3 mg/kg | Participants received AIN457 0.3 mg/kg IV on Day 1. |
| FG001 | AIN457 1.0 mg/kg | Participants received AIN457 1.0 mg/kg IV on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Safety Set |
|
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| Biological |
|
| Investigator Global Assessment (IGA) Scores | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32 |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Novartis Investigative Site | High Point | North Carolina | 27262 | United States |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16634 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37215 | United States |
| FG002 | AIN457 3.0 mg/kg | Participants received AIN457 3.0 mg/kg IV on Day 1. |
| FG003 | Placebo | Participants received placebo to AIN457A IV on day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| Excluded Set |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 0.3 mg/kg | Participants received AIN457 0.3 mg/kg IV on Day 1. |
| BG001 | AIN457 1.0 mg/kg | Participants received AIN457 1.0 mg/kg IV on Day 1. |
| BG002 | AIN457 3.0 mg/kg | Participants received AIN457 3.0 mg/kg IV on Day 1. |
| BG003 | Placebo | Participants received placebo to AIN457A IV on day 1. |
| BG004 | 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 | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | Posted | baseline, week 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in PASI | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | Posted | baseline, weeks 12, 14, 16, 20, 24, 28 and 32 |
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| Secondary | Investigator Global Assessment (IGA) Scores | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | Posted | baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32 |
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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 0.3 mg/kg | AIN457 0.3 mg/kg | 1 | 20 | 3 | 20 | ||
| EG001 | AIN457 1 mg/kg | AIN457 1 mg/kg | 1 | 20 | 4 | 20 | ||
| EG002 | AIN457 3 mg/kg | AIN457 3 mg/kg | 0 | 20 | 5 | 20 | ||
| EG003 | Placebo | Placebo | 0 | 20 | 3 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEMORAL HERNIA, OBSTRUCTIVE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| NECROTISING COLITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| CYST | General disorders | MedDRA | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
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| GENITAL HERPES | Infections and infestations | MedDRA | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDRA | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| BACK INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
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| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| PERIRECTAL ABSCESS | Infections and infestations | MedDRA | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA | 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 | 862-778-8300 |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Withdrawal by Subject |
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| Male |
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| Participants |
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| Participants |
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