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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: Cyclosporine A microemulsion; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00438360

COLO400CIT04

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 2 patient groups, including a placebo group

Cyclosporine A

Active Comparator group

Description:

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

Treatment:

Drug: Cyclosporine A microemulsion

Placebo

Placebo Comparator group

Description:

Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Treatment:

Drug: Placebo