NCT07449702

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

• Status: 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

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.

Detailed description

This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.

Conditions

• Plaque Psoriasis

Interventions

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

Timeline

• Start date: 2026-02-23
• Primary completion: 2028-11-01
• Completion: 2029-01-01
• First posted: 2026-03-04
• Last updated: 2026-04-01

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study