Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis (NCT00244842) | Clinical Trial Compass
CompletedPhase 3
Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis
Canada451 participantsStarted 2004-12
Plain-language summary
The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Plaque psoriasis ≥ 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.
* Plaque psoriasis involving ≥10% of the body surface area (BSA) at screening and prior to randomization at the day 0 visit.
* PASI score ≥10 at screening and prior to randomization at the day 0 visit.
* Not pregnant or nursing or planning to become pregnant during the course of the study.
* 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 …
What they're measuring
1
Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin.