Clinical trial NCT00408187 (phase 3, status: completed)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: voclosporin, ciclosporin, placebo
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Eligibility criteria:

        Inclusion Criteria:

          -  Aged greater than or equal to 18 years of age inclusive at time of screening.

          -  Diagnosed with plaque psoriasis greater than or equal to 6 months prior to screening.

          -  Diagnosis of stable, plaque psoriasis; i.e. psoriasis must not be spontaneously
             improving or worsening in the 4 weeks prior to the screening visit.

          -  Psoriasis failing at least one systemic treatment regimen or where other systemic
             therapies are contraindicated or where tolerability is an issue.

          -  Plaque psoriasis involving greater than or equal to 10% of the body surface area and a
             SPGA score greater than or equal to 3 at screening and prior to randomization at the
             day 0 visit.

          -  Not pregnant or nursing.

          -  Sexually active women of childbearing potential or less than 1 year post-menopausal
             and sexually active men who are not surgically sterile must use a reliable form of
             birth control during study treatment and for at least 3 months after the last dose of
             study drug. Surgically sterile females are not considered to be of childbearing
             potential. Reliable forms of birth control include oral or depot contraceptives, and
             double-barrier methods.

          -  Written informed consent prior to washout and screening procedures.

          -  Able to keep study appointments and cooperate with all study requirements, in the
             opinion of the Investigator.

        Exclusion Criteria:

          -  Has generalized erythrodermic, guttate, or pustular psoriasis.

          -  Have other dermatoses that would interfere with the evaluation of psoriasis, at the
             discretion of the Investigator.

          -  A current malignancy or history of malignancy within 5 years or a history of lymphoma
             at any time. Subjects can be enrolled with a history of squamous or basal cell
             carcinoma that has been surgically excised or removed with curettage and
             electrodesiccation.

          -  Has a current, uncontrolled bacterial, viral, or fungal infection that requires
             intravenous antibiotics or antifungals or has had such infections within 60 days prior
             to screening.

          -  A known history of tuberculosis.

          -  Serologic evidence or known latent HIV, HBV or HCV virus.

          -  Uncontrolled hypertension of systolic blood pressure greater than or equal to 160 mmHg
             or diastolic blood pressure greater than or equal to 90 mmHg.

          -  MDRD GFR < 60 mL/min.

          -  Variation between the screening and Visit 1 SCr greater than or equal to 30%.

          -  ALT, AST, GGT greater than or equal to 2x upper limit of normal (ULN).

          -  White blood cell count less than or equal to 2.8 x 10 to the ninth power/L.

          -  Requires the following prohibited medications or treatments during the washout or
             treatment period: drugs potentiating the nephrotoxicity of voclosporin, drugs
             interfering with its pharmacokinetics, drugs considered to contribute to psoriasis
             flare; or, systemic and topical psoriasis medication that may interfere with
             assessment of study drug efficacy.

          -  Has used any investigational drug or device within 30 days or 10 half lives (whichever
             is longer) prior to the screening visit.

          -  Current participation in another clinical trial of any drug or biological agent.

          -  Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3
             months of randomization. Biological agents include any virus, live vaccine,
             therapeutic serum, toxin, antitoxin, monoclonal antibodies or analogous product
             applicable to the prevention, treatment, or cure of diseases or injuries of man.

          -  Previous exposure to voclosporin.

          -  A history of clinically defined allergy to ciclosporin, constituents of Neoral or any
             of the constituents of the ISA247 formulation.

          -  A history of alcoholism or drug addiction.

          -  Weighs < 45kg (99 lbs).

          -  A history of disease, including mental/emotional disorder that would interfere with
             the subject's participation in the study, in the evaluation of his/her response or
             that might cause the administration of voclosporin to pose a significant risk to the
             subject, in the opinion of the Investigator.