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The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine A | Active Comparator | Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations |
|
| Placebo | Placebo Comparator | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine A microemulsion | Drug | Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score | PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score >75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was >= 75%. In all the other cases the patient was considered as success (no relapse). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Clinical Relapse | Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) >75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment. | 24 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bari | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine A | Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations. |
| FG001 | Placebo | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine A | Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Baseline measures are based on intention to treat (ITT) population. |
| 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 | Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score | PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score >75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was >= 75%. In all the other cases the patient was considered as success (no relapse). | Intent to treat population. | Posted | Number | Participants | 24 weeks |
|
24 weeks
Safety Population
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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 | Cyclosporine A | Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast mass | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Placebo | Drug | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations |
|
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. |
| baseline and week 24 |
| Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis | BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( [Height(in) x Weight(lbs) ]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed | Baseline and week 24 |
| Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus | Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis). | Baseline and week 24 |
| Safety / Tolerability Assessed by Adverse Events | 24weeks |
| Other |
|
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
| BG002 | Total | Total of all reporting groups |
| Number |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations. |
|
|
| Secondary | Proportion of Participants With Clinical Relapse | Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) >75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment. | Intent to treat population. | Posted | Number | proportion of participants | 24 weeks |
|
|
|
| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. | Intention to treat (ITT) population. Patients with a value of PASI at baseline and 24 weeks were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and week 24 |
|
|
|
| Secondary | Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis | BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( [Height(in) x Weight(lbs) ]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed | Intent to Treat (ITT) population. Patients with a value of BSA at baseline and 24 weeks were included in this analysis. | Posted | Mean | Standard Deviation | BSA (m^2) | Baseline and week 24 |
|
|
|
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus | Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis). | Intent to treat (ITT) population. Patients with a value of VAS at baseline and 24 weeks were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and week 24 |
|
|
|
| Secondary | Safety / Tolerability Assessed by Adverse Events | Not Posted | Number | patient | 24weeks |
| 1 |
| 160 |
| 19 |
| 160 |
| EG001 | Placebo | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations. | 0 | 79 | 1 | 79 |
| Hypertriglyceridaemia | Metabolism and nutrition 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.
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |