A PHASE III, RANDOMIZED, MULTICENTRE, DOUBLE-BLIND, PLACEBO ANDCYCLOSPORINE CONTROLLED STUDY OF ISA247 IN PLAQUE PSORIASISPATIENTS (ISA05-25) - None available

Conditions: Patient has stable, moderate to severe, plaque psoriasis over the previous 6 months
i.e., psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.

Registration Number: EUCTR2006-001352-13-DE

Lead Sponsor: Isotechnika Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

Males and females aged =18 years;
Plaque psoriasis = 6 months;
Stable, moderate to severe, plaque psoriasis;
Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or not intolerated;
Plaque psoriasis involving =10% of the body surface area;
PASI score =3; BSA =10
Not pregnant or nursing;
Reliable form of birth control for both males and females;
Written Informed Consent.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Generalised erythrodermic, guttate or pustular psoriasis;
Other dermatoses that would interfere with the evaluation of psoriasis;
Current malignancy or history of malignancy within 5 years or a history of lymphoma at any time;
Current, uncontrolled bacterial, viral or fungal infection;
Known history of tuberculosis;
Evidence of HIV, HBV or HCV infection;
Uncontrolled hypertension;
Impaired liver or kidney function;
White blood cell count = 2.8 x 1, 000, 000, 000/L;
Use of an investigational drug or device within 30 days or 10 half lives (whichever is longer);
Previous use of ISA247;
Use of biological agents within 3 months;
History of clinically defined allergy to ciclosporin or any of the constituents of the
ISA247 formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol);
History of alcoholism or drug addiction;
Weighs < 45 kg.