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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-11-30

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.

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Detailed Description

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Conditions

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Chronic Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Cyclosporine A microemulsion

Intervention Type 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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Cyclosporine A microemulsion

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Neoral

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No