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

• ClinicalTrials.gov Identifier: NCT00438360
• Recruitment Status: Completed
• First Posted: February 22, 2007
• Results First Posted: August 9, 2011
• Last Update Posted: August 9, 2011
• Sponsor: Novartis Pharmaceuticals
• Information provided by: Novartis

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Plaque Psoriasis	Drug: Cyclosporine A microemulsion; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 243 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: May 2006
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: November 2007

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	Drug: 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; Other Name: Neoral
Placebo Comparator: Placebo; Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations	Drug: Placebo; Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

Italy

Novartis Investigative Site

Bari, Italy

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis; Novartis

More Information

• Responsible Party: External Affairs, Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00438360
• Other Study ID Numbers: COLO400CIT04
• First Posted: February 22, 2007
• Results First Posted: August 9, 2011
• Last Update Posted: August 9, 2011
• Last Verified: July 2011

Keywords provided by Novartis:

Cyclosporine, chronic plaque psoriasis, intermittent therapy

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Cyclosporine; Cyclosporins; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors