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

Recruiting now · Phase 2

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT07449702

Run by

Oruka Therapeutics, Inc.

People needed

240

Starts

2026-02-23

Expected to finish

2030-07-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent by participants from previous trial choosing to transition into the OLE.
• Participants who have successfully completed the preceding trial.
• For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
• For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception

You may not qualify if…

• 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.

Where it is running

• Oruka Therapeutics Investigative Site — Fountain Valley, California, United States (enrolling)
• Oruka Therapeutics Investigative Site — Los Angeles, California, United States (enrolling)
• Oruka Therapeutics Investigative Site — San Diego, California, United States (enrolling)
• Oruka Therapeutics Investigative Site — Santa Ana, California, United States (enrolling)
• Oruka Therapeutics Investigative Site — Santa Monica, California, United States (enrolling)
• Oruka Therapeutics Investigative Site — Cromwell, Connecticut, United States (enrolling)
• Oruka Therapeutics Investigative Site — Miami, Florida, United States (enrolling)
• Oruka Therapeutics Investigative Site — Rolling Meadows, Illinois, United States (enrolling)
• Oruka Therapeutics Investigative Site — Bowling Green, Kentucky, United States (enrolling)
• Oruka Therapeutics Investigative Site — Rockville, Maryland, United States (enrolling)
• Oruka Therapeutics Investigative Site — Boston, Massachusetts, United States (enrolling)
• Oruka Therapeutics Investigative Site — Detroit, Michigan, United States (enrolling)
• Oruka Therapeutics Investigative Site — New York, New York, United States (enrolling)
• Oruka Therapeutics Investigative Site — New York, New York, United States (enrolling)
• Oruka Therapeutics Investigative Site — Portland, Oregon, United States (enrolling)
• Oruka Therapeutics Investigative Site — Portland, Oregon, United States (enrolling)
• Oruka Therapeutics Investigative Site — Houston, Texas, United States (enrolling)
• Oruka Therapeutics Investigative Site — Norfolk, Virginia, United States (enrolling)
• Oruka Therapeutics Investigative Site — Edmonton, Alberta, Canada (enrolling)
• Oruka Therapeutics Investigative Site — Edmonton, Alberta, Canada (enrolling)
• Oruka Therapeutics Investigative Site — Surrey, British Columbia, Canada (enrolling)
• Oruka Therapeutics Investigative Site — London, Ontario, Canada (enrolling)
• Oruka Therapeutics Investigative Site — Markham, Ontario, Canada (enrolling)
• Oruka Therapeutics Investigative Site — Peterborough, Ontario, Canada (enrolling)
• Oruka Therapeutics Investigative Site — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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