🏛️ Verified NIH Record • Updated 2026-08-03
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis (NCT07449702)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Oruka Therapeutics, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (6 items).
Location: Oruka Therapeutics Investigative Site — Fountain Valley, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001
- Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
- Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.
- Participant is pregnant or breastfeeding.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (26 Sites)
- Oruka Therapeutics Investigative Site — Fountain Valley, California
- Oruka Therapeutics Investigative Site — Los Angeles, California
- Oruka Therapeutics Investigative Site — San Diego, California
- Oruka Therapeutics Investigative Site — Santa Ana, California
- Oruka Therapeutics Investigative Site — Santa Monica, California
- Oruka Therapeutics Investigative Site — Cromwell, Connecticut
- Oruka Therapeutics Investigative Site — Miami, Florida
- Oruka Therapeutics Investigative Site — Rolling Meadows, Illinois
- Oruka Therapeutics Investigative Site — Bowling Green, Kentucky
- Oruka Therapeutics Investigative Site — Rockville, Maryland
- Oruka Therapeutics Investigative Site — Boston, Massachusetts
- Oruka Therapeutics Investigative Site — Detroit, Michigan
- Oruka Therapeutics Investigative Site — New York, New York
- Oruka Therapeutics Investigative Site — New York, New York
- Oruka Therapeutics Investigative Site — Portland, Oregon
- Oruka Therapeutics Investigative Site — Portland, Oregon
- Oruka Therapeutics Investigative Site — Houston, Texas
- Oruka Therapeutics Investigative Site — Norfolk, Virginia
- Oruka Therapeutics Investigative Site — Edmonton, Alberta
- Oruka Therapeutics Investigative Site — Edmonton, Alberta
- Oruka Therapeutics Investigative Site — Surrey, British Columbia
- Oruka Therapeutics Investigative Site — London, Ontario
- Oruka Therapeutics Investigative Site — Markham, Ontario
- Oruka Therapeutics Investigative Site — Peterborough, Ontario
- Oruka Therapeutics Investigative Site — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.