Phase 3
Completed N=243
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT00438360 ↗Enrolled (actual)
243
Serious AEs
0.4%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score — 87; 36; 73; 43 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score |
87; 36; 73; 43 | — |
| SECONDARY Proportion of Participants With Clinical Relapse |
0.369; 0.456 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
5.70; 6.86 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis |
8.12; 10.45 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus |
17.32; 25.44 | — |
| SECONDARY Safety / Tolerability Assessed by Adverse Events |
— | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00438360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.