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

Phase 3

Completed

• Conditions: Chronic Plaque Psoriasis
• Interventions: Drug: Cyclosporine A microemulsion; Drug: Placebo

• Registration Number: NCT00438360
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-02-21
• Study First Submitted QC: 2007-02-21
• Study First Posted: 2007-02-22
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2010-12-15
• Status Verified: 2011-07
• Results First Submitted QC: 2011-07-13
• Last Update Submitted: 2011-07-13
• Results First Posted: 2011-08-09
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine A	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
Placebo	Placebo	Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Primary Outcome Measures

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

Name	Time	Method
Proportion of Participants With Clinical Relapse	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.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	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.
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis	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
Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus	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).
Safety / Tolerability Assessed by Adverse Events	24weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Bari, Italy