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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins

Criteria

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