NCT07090330

ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

A Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (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, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

Detailed description

This is a proof-of-concept study evaluating ORKA-001 in patients with moderate-to-severe psoriasis with study drug administration divided into an Induction period followed by a Maintenance period. Following completion of the Maintenance period at Week 52, participants will have the option to enter into the open-label extension (OLE) study.

Conditions

• Plaque Psoriasis

Interventions

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

Timeline

• Start date: 2025-07-18
• Primary completion: 2026-04-01
• Completion: 2027-05-01
• First posted: 2025-07-29
• Last updated: 2026-03-17

Locations

26 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study