Patient has stable, moderate to severe, plaque psoriasis over the previous 6 months
Conditions
Interventions
Product Name: ISA247
Product Code: ISA247
Pharmaceutical Form: Capsule, soft
Current Sponsor code: ISA247
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharma
Sponsors
Isotechnika Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess superiority in the proportion of subjects achieving a score of “clear” or ”almost clear” in the Static Physician’s Global Assessment (SPGA) score at 12 weeks ISA247 compared with placebo.;Secondary Objective: 1) To show non-inferiority of ISA247 compared with ciclosporin in the proportion of subjects achieving a score of “clear” or ”almost clear” in the Static Physician’s Global Assessment (SPGA) score at 12 weeks. 2) Superiority in de novo hypertriglyceridaemia at 24 weeks of ISA247 compared with ciclosporin. 3) Superiority in de novo hypertension at 24 weeks of ISA247 compared with ciclosporin. 4) Superiority of renal function, hypertension or hyperlipidaemia compared with ciclosporin at 12 and 24 weeks. 5) To determine the proportion of subjects achieving a score of “clear” or ”almost clear” in the SPGA score at 12 and 24 weeks compared with ciclosporin. 6) Proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI-75) at 12 weeks compared with placebo. ;Primary end point(s): To assess superiority in the proportion of subjects achieving a score of “clear” or ”almost clear” in the Static Physician’s Global Assessment (SPGA) score at 12 weeks ISA247 compared with placebo. | — |
Countries
Germany
Outcome results
None listed