Study to Find the Best Dose of ORKA-002 for Adults With Moderate-to-Severe Plaque Psoriasis Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

What this Trial Is About

Researchers are evaluating the efficacy and safety of ORKA-002 in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled study aims to find the best induction dosing regimen of ORKA-002. Approximately 160 adult participants with this skin condition will take part in the Phase 2 trial. Participants will be randomly assigned to receive one of three different induction dosing regimens of ORKA-002 or a placebo. Both ORKA-002 and placebo are given by subcutaneous injection. The study includes three periods Screening, Induction, and Post-treatment Follow-up. During the study, participants will undergo assessments including evaluations of skin severity using PASI and IGA scores. Researchers will monitor treatment-emergent adverse events through Week 48. The primary outcome is the proportion of participants achieving complete clearance of psoriasis at Week 16. The total participation time includes screening, treatment, and follow-up periods to assess safety and treatment response.

Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis