At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓Chronic plaque psoriasis in disease remission (PASI ≤75% of baseline PASI before cyclosporine)
- ✓Remission achieved with cyclosporine monotherapy (max 5 mg/kg/day) for >8 weeks and <16 weeks
- ✓PASI still <75% of baseline PASI at randomization (8±2 days after remission)
- ✕Abnormal renal function (creatinine ≥10% above upper limit of reference range)
- ✕Severe chronic degenerative diseases
- ✕Severe uncontrolled hypertension
- ✕Body weight >110 kg
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Cyclosporine A microemulsion and Placebo for Chronic Plaque Psoriasis. Completed, enrolled 243 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations