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

Summary

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

Detailed Description

This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 in approximately 160 adult participants with moderate-to-severe plaque psoriasis. The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-001 compared to placebo and will include 3 maintenance regimens. The study will consist of 4 periods: * Screening Period of up to 6 weeks * Induction Period of up to 28 weeks (Day 1 \[Baseline\] to Week 28) * Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100) * Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.

Eligibility Criteria

Interventions