NCT07290569

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

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Oruka Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	ORKA-001	ORKA-001 administered by subcutaneous (SC) injection
OTHER	Placebo	Placebo administered by subcutaneous (SC) injection

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-06-01
• Completion: 2028-12-01
• First posted: 2025-12-18
• Last updated: 2026-03-30

Locations

26 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study