Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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A 24-week, Double-blind, Randomized, Placebo-controlled, Multicenter Study, to Evaluate the Effectiveness of Cyclosporine 2,5 mg/kg/Day Bid Twice a Week on Reducing Relapse Rate, in Maintenance Patients With Chronic Plaque Psoriasis

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: Cyclosporine A microemulsion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Outpatients 18 years of age and older (max 65 years) Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for >8 weeks and <16 weeks PASI still <75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission) Exclusion criteria: Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range) Severe chronic degenerative diseases Severe uncontrolled hypertension Body weigh >110 kg Abnormal liver function Hyperkalemia or hyperuricemia Clinically significant impairment of hematopoietic and cardiovascular function Concomitant therapy with nephrotoxic medications Patients with malignancy or a history of malignancy Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception Clinically significant uncontrolled bacterial, viral or fungal infection Evidence of drug and/or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclosporine A<br>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 | Drug: Cyclosporine A microemulsion<br>* 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<br>* Other names: Neoral;|
| Placebo Comparator: Placebo<br>Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations | Drug: Placebo<br>* Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclosporine, chronic plaque psoriasis, intermittent therapy