MedTrace Logo

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

NCT00438360 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2011-08-09

Study results available
· View outcomes & findings →

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.

Conditions

  • Chronic Plaque Psoriasis

Interventions

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00438360 on ClinicalTrials.gov