Randomized Study of ORKA-001 Injections for Adults With Moderate-to-Severe Plaque Psoriasis to Determine Optimal Dose Compared to Placebo

What this Trial Is About

Researchers are evaluating the efficacy and safety of ORKA-001 in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled phase 2 study aims to identify the best induction dosing regimen of ORKA-001 by comparing three different dose levels with a placebo. The study includes approximately 160 adult participants who have had plaque psoriasis for more than six months and meet specific severity criteria. Participants will be assigned to receive one of three doses of ORKA-001 or a placebo during the induction period, which lasts up to 28 weeks. Following this, they may enter a maintenance period lasting up to about 72 weeks, where three maintenance regimens are evaluated based on participant response. ORKA-001 and placebo are given by subcutaneous injection. After treatment, participants can opt to join an open-label extension study or enter a follow-up period of 48 weeks if they withdraw or do not join the extension. During the study, participants will undergo multiple assessments including skin evaluations using PASI and IGA scores to measure psoriasis severity and improvement. Safety will be monitored throughout the study and during follow-up by tracking adverse events. The primary outcome focuses on the proportion of participants achieving complete clearance of psoriasis at week 16. Total participation may last up to nearly two years, including screening, treatment, maintenance, and follow-up phases.

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis