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This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at baseline and subjects will be observed for up to 26 weeks following the infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 | Experimental | AIN457A 3mg/kg was administered intravenously as a single dose. |
|
| Placebo | Placebo Comparator | Placebo was administered intravenously as a single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Biological | single infusion of 3 mg/kg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score | The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement. | Baseline, Week 4 |
| Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score | The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. |
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Inclusion Criteria:
Males or females, aged 18-69 at time of consent.
Post menopausal or surgically sterile female patients are allowed. Male patients must be willing to use contraception method at least for 3 months following the completion of the study. Women of child-bearing potential will not be allowed to participate.
Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet both of the following criterion:
Stable plaque psoriasis at screening and randomization.
PASI score of 12 or greater at randomization.
Able to communicate well with the investigator, and to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Patients must have normal laboratory values for screening laboratory test results of hematological (hemoglobin, WBCs, neutrophils, platelets) and renal (serum creatinine) assessments. For the transaminases, aspartate aminotransferase and alanine aminotransferase, levels 1.5 times the upper limit of normal will be accepted. For the additional hepatic laboratory results (alkaline phosphatase, gamma-glutamyltransferase, bilirubin), patients must have non-clinically significant values.
Exclusion Criteria:
Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
Men who are planning to initiate a pregnancy while enrolled in the study or for 3 months following completion of the study.
Women of child-bearing potential are not allowed in the study.
Used any investigational drug within the previous 4 weeks.
Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20926833 | Derived | Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, Antoni C, Draelos Z, Gold MH; Psoriasis Study Group; Durez P, Tak PP, Gomez-Reino JJ; Rheumatoid Arthritis Study Group; Foster CS, Kim RY, Samson CM, Falk NS, Chu DS, Callanan D, Nguyen QD; Uveitis Study Group; Rose K, Haider A, Di Padova F. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010 Oct 6;2(52):52ra72. doi: 10.1126/scitranslmed.3001107. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 | AIN457A 3mg/kg was administered intravenously as a single dose. |
| FG001 | Placebo | Placebo was administered intravenously as a single dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 | AIN457A 3mg/kg was administered intravenously as a single dose. |
| BG001 | Placebo | Placebo was administered intravenously as a single dose. |
| 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 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score | The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement. | All participants | Posted | Number | Percentage change in PASI mean score | Baseline, Week 4 |
|
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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 | AIN457A | AIN457A 3mg/kg was administered intravenously as a single dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal degeneration | Eye disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Drug |
single infusion of placebo |
|
| Day 182 |
| Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | Day 182 |
| Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | Day 182 |
| Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | Day 182 |
| Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | Day 182 |
| Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | Day 182 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
AIN457A 3mg/kg was administered intravenously as a single dose.
| OG001 | Placebo | Placebo was administered intravenously as a single dose. |
|
|
| Secondary | Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | The population included all AIN457 treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz. | Posted | Median | Full Range | days | Day 182 |
|
|
|
| Secondary | Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz. | Posted | Mean | Standard Deviation | ug/mL | Day 182 |
|
|
|
| Secondary | Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | All AIN457A treatment group participants | Posted | Mean | Standard Deviation | day*ug/mL | Day 182 |
|
|
|
| Secondary | Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz. | Posted | Mean | Standard Error | Liters | Day 182 |
|
|
|
| Secondary | Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz. | Posted | Mean | Standard Deviation | Liters/day | Day 182 |
|
|
|
| Primary | Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score | The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement. | All participants | Posted | Number | Percentage of participants | Baseline, Week 4 |
|
|
|
| Secondary | Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2) | Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above. | All AIN457A treatment group participants | Posted | Mean | Standard Deviation | day | Day 182 |
|
|
|
| 1 |
| 18 |
| 9 |
| 18 |
| EG001 | Placebo | Placebo was administered intravenously as a single dose. | 0 | 18 | 8 | 18 |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Injection site infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood ketone body increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin maceration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
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.
| Change in IGA score = 1 |
|
| Change in IGA score = 2 |
|
| Change in IGA score = 3 |
|