A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of ISA247 in patients with chronic plaque psoriasis

Background Use of current oral calcineurin inhibitors for the treatment of psoriasis is limited by toxicity. Objective Evaluate the safety and efficacy of ISA247, a new oral calcineurin inhibitor, in plaque psoriasis patients. Methods This 12-week, randomized, double-blind, placebo-controlled, parallel-group study included 201 plaque psoriasis patients with ≥ 10% body surface area involvement. Patients were randomized to placebo, ISA247 0.5 mg/kg/d, and ISA247 1.5 mg/kg/d groups. End points included a 2-point reduction in the Static Global Assessment score and a 75% reduction in the Psoriasis Area and Severity Index. Results A 2-point SGA reduction was achieved in 0% (placebo), 15.6% (0.5 mg/kg/d), and 45.1% (1.5 mg/kg/d) ( P P Limitations Longer-term studies are needed to evaluate the effect of ISA247 on renal function. Conclusion ISA247 appears safe and effective for treating moderate to severe psoriasis.