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Completed

NCT Number: NCT00438360

Efficacy and Safety of Cyclosporine A Microemulsion 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.

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Key information

Conditions

Chronic Plaque Psoriasis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

Bari, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine A microemulsion

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

Other names: Neoral

Placebo

Drug

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

Primary outcomes

  1. Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score

    Time frame: 24 weeks

    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).

Secondary outcomes

  1. Proportion of Participants With Clinical Relapse

    Time frame: 24 weeks

    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.

  2. Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

    Time frame: baseline and week 24

    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.

  3. Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis

    Time frame: Baseline and week 24

    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

  4. Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus

    Time frame: Baseline and week 24

    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).

  5. Safety / Tolerability Assessed by Adverse Events

    Time frame: 24weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 22, 2007
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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