EUCTR2006-001352-13-DEActive, not recruitingNot Applicable
A PHASE III, RANDOMIZED, MULTICENTRE, DOUBLE-BLIND, PLACEBO ANDCYCLOSPORINE CONTROLLED STUDY OF ISA247 IN PLAQUE PSORIASISPATIENTS (ISA05-25) - None available
Isotechnika Inc0 sites900 target enrollmentStarted: July 31, 2006Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 900
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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