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

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

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.

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