FindTrial
Sign In

A 24-weeks , national, multicenter, double blind controlled vs placebo trial to evaluate the efficacy of Neoral ciclosporine 5mg/kg/day , twice a week administered in reduction of the rate of relapse in pz with chronic plaque psoriasis on remission. PREWENT Study - PREWENT Study

A 24-weeks , national, multicenter, double blind controlled vs placebo trial to evaluate the efficacy of Neoral ciclosporine 5mg/kg/day , twice a week administered in reduction of the rate of relapse in pz with chronic plaque psoriasis on remission. PREWENT Study - PREWENT Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000207-42-IT
Enrollment
264
Registered
2006-04-21
Start date
2006-03-01
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic plaque psoriasis on remission MedDRA version: 6.1 Level: PT Classification code 10037153

Interventions

Trade Name: SANDIMMUN NEORAL 25 50 CPS Pharmaceutical Form: Capsule, soft INN or Proposed INN: Ciclosporin CAS Number: 59865-59-5 Concentration unit: mg milligram(s) Concentration type: equal Concent

Sponsors

NOVARTIS FARMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: XXXX18 Age 65 years; Patients with chronic plaque psoriasis on remission PASI 8804;75 of PASI before Neoral treatment course after a treatment course with Neoral given continuously for 8 but 16 weeks; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients on remission after a treatment course with other drugs than Neoral Body weight 110 kg; Patients with abnormal renal function creatinine 10 UNL Patients with severe chronic degenerative diseases Severe uncontrolled hypertension Severe uncontrolled hyperlipidemia Bilirubin or liver enzymes 2 the UNL; Platelets count 75,000 mm3 with neutrophils 1,500 mm3 and/or leucopenia 2,500 mm3 , or anaemia emoglobine 6g/dl at basal Clinically significant uncontrolled bacterial, viral or fungal infection

Design outcomes

Primary

MeasureTime frame
Main Objective: Relapse rate during the 24-weeks treatment with Neoral ciclosporine 5mg/kg/day twice a week;Secondary Objective: 1. time to relapse 2.change from baseline in PASI score 3.change from baseline in BSA score 4.change from baseline in VAS score for pruritus 5.Safety and tolerability;Primary end point(s): relapse rate—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026