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The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Experimental | Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab (AIN457) | Drug | Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75) | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). PASI 75 was defined as participants achieving >= 75% improvement from baseline. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in PASI Score | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). A negative change from baseline indicates improvement. |
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Inclusion criteria:
Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Novartis Investigative Site |
The overall treatment period consisted of a 4 week induction period (Day 1 and weeks 1, 2, 3 and 4) and a 12 week maintenance period (weeks 8 and 12). All participants entered and completed both periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab (AIN457) 300 mg | Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Week 4 |
| Percentage of Participants Achieving PASI 50 or PASI 75 | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively. | Week 4 |
| Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. | Week 16 |
| Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement. | Week 16 |
| Percentage of Participants Achieving DLQI 0 or 1 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | Week 16 |
| Fukuoka |
| Fukuoka |
| 814-0180 |
| Japan |
| Novartis Investigative Site | Isehara | Kanagawa | 259-1193 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 550-0012 | Japan |
| Novartis Investigative Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Chiyoda-ku | Tokyo | 102-8798 | Japan |
| Novartis Investigative Site | Itabashi-ku | Tokyo | 173-8606 | Japan |
| Novartis Investigative Site | Itabashi-ku | Tokyo | 173-8610 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-8471 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 141 8625 | Japan |
| Novartis Investigative Site | Shinjuku-Ku | Tokyo | 169-0073 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab (AIN457) 300 mg | Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12. |
| 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 |
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| 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 Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75) | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). PASI 75 was defined as participants achieving >= 75% improvement from baseline. | The full analysis set, which included all participants who received at least one dose of study drug, was analyzed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Mean Percent Change From Baseline in PASI Score | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). A negative change from baseline indicates improvement. | The full analysis set, which included all participants who received at least one dose of study drug, was analyzed. | Posted | Mean | Standard Deviation | Percent change | Week 4 |
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| Secondary | Percentage of Participants Achieving PASI 50 or PASI 75 | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively. | The full analysis set, which included all participants who received at least one dose of study drug, was analyzed. | Posted | Number | Percentage of participants | Week 4 |
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| Secondary | Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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). PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. | The full analysis set, which included all participants who received at least one dose of study drug, was analyzed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement. | The full analysis set was considered for the analysis. Only participants who had both baseline and week 16 values were included in the analysis. The full analysis set included all participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Percent change | Week 16 |
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| Secondary | Percentage of Participants Achieving DLQI 0 or 1 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | The full analysis set, which included all participants who received at least one dose of study drug, was analyzed. | Posted | Number | Percentage of participants | Week 16 |
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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 | Entire Period - Secukinumab (AIN457) | Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12. | 0 | 34 | 24 | 34 | ||
| EG001 | Induction Period - Secukinumab (AIN457) | During the induction period, participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, and 4. | 0 | 34 | 10 | 34 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Gastric polyps | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Angular cheilitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Tinea versicolour | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (18.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.1) | 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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