NCT07474792

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

A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Oruka Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 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-002 in adult participants with moderate-to-severe plaque psoriasis.

Detailed description

This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 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-002 compared to placebo. The study will consist of 3 periods: * Screening Period * Induction Period * Post-treatment Follow-up Period

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	ORKA-002	ORKA-002 administered by subcutaneous (SC) injection
OTHER	Placebo	Placebo administered by subcutaneous (SC) injection

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-10-01
• Completion: 2029-04-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Regulatory

• FDA-regulated drug study