An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis

"In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54."

In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.

"In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54."