Conditions: Psoriasis
Keywords: Randomized Controlled Trials Immunosuppression Adult Chronic Disease Dermatologic Agents Female Humans Male Middle Aged Severity of Illness Index Treatment Outcome Quality of Life Double-Blind Method
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 451
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.

Detailed description:
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.

Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.

Arms:
arm 1: Placebo arm 2: Voclosporin 0.2 mg/kg po BID arm 3: Voclosporin 0.3 mg/kg po BID arm 4: Voclosporin 0.4 mg/kg po BID

Interventions: intervention 1: voclosporin intervention 2: Placebo
Intervention descriptions: intervention 1: voclosporin 0.2, 0.3, or 0.4 mg/kg po BID intervention 2: Placebo

Protocol document: