The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.
Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
309
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
To investigate long-term safety and tolerability of voclosporin
Time frame: Sixty weeks of continuous treatment
To determine the proportion of subjects achieving and/or maintaining a PASI-75
Time frame: Sixty weeks of continuous treatment
To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA
Time frame: Sixty weeks of continuous treatment
To evaluate the effect of voclosporin on subject quality of life
Time frame: Sixty weeks of continuous treatment
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