NCT07449702From ClinicalTrials.govRecruiting

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

Plaque Psoriasis

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Oruka Therapeutics, Inc.
Enrolment target: 240
Started: 23 February 2026
Main results due: May 2030
Study sites: 34
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Signed informed consent by participants from previous trial choosing to transition into the OLE.
2. Participants who have successfully completed the preceding trial.
3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
4. 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

Exclusion Criteria:

1. 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
2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
3. 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.
4. 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.
5. Participant is pregnant or breastfeeding.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(34)

Oruka Therapeutics Investigative Site
Phoenix, Arizona, United States
Recruiting
Oruka Therapeutics Investigative Site
Fountain Valley, California, United States
Recruiting
Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Recruiting
Oruka Therapeutics Investigative Site
San Diego, California, United States
Recruiting
Oruka Therapeutics Investigative Site
Santa Ana, California, United States
Recruiting
Oruka Therapeutics Investigative Site
Santa Monica, California, United States
Recruiting
Oruka Therapeutics Investigative Site
Cromwell, Connecticut, United States
Recruiting
Oruka Therapeutics Investigative Site
Miami, Florida, United States
Recruiting
Oruka Therapeutics Investigative Site
Rolling Meadows, Illinois, United States
Recruiting
Oruka Therapeutics Investigative Site
Bowling Green, Kentucky, United States
Recruiting
Oruka Therapeutics Investigative Site
Rockville, Maryland, United States
Recruiting
Oruka Therapeutics Investigative Site
Boston, Massachusetts, United States
Recruiting
Oruka Therapeutics Investigative Site
Detroit, Michigan, United States
Recruiting
Oruka Therapeutics Investigative Site
New York, New York, United States
Recruiting
Oruka Therapeutics Investigative Site
New York, New York, United States
Recruiting
Oruka Therapeutics Investigative Site
Mason, Ohio, United States
Recruiting
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Recruiting
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Recruiting
Oruka Therapeutics Investigative Site
Frisco, Texas, United States
Recruiting
Oruka Therapeutics Investigative Site
Houston, Texas, United States
Recruiting
Oruka Therapeutics Investigative Site
Webster, Texas, United States
Recruiting
Oruka Therapeutics Investigative Site
Norfolk, Virginia, United States
Recruiting
Oruka Therapeutics Investigative Site
Edmonton, Alberta, Canada
Recruiting
Oruka Therapeutics Investigative Site
Edmonton, Alberta, Canada
Recruiting
Oruka Therapeutics Investigative Site
Surrey, British Columbia, Canada
Recruiting
Oruka Therapeutics Investigative Site
Surrey, British Columbia, Canada
Recruiting
Oruka Therapeutics Investigative Site
Ajax, Ontario, Canada
Recruiting
Oruka Therapeutics Investigative Site
London, Ontario, Canada
Recruiting
Oruka Therapeutics Investigative Site
Markham, Ontario, Canada
Recruiting
Oruka Therapeutics Investigative Site
Peterborough, Ontario, Canada
Recruiting
Oruka Therapeutics Investigative Site
Toronto, Ontario, Canada
Recruiting
Oruka Therapeutics Investigative Site
Waterloo, Ontario, Canada
Recruiting
Oruka Therapeutics Investigative Site
Montreal, Quebec, Canada
Recruiting
Oruka Therapeutics Investigative Site
Québec, Quebec, Canada
Recruiting

Showing 34 of 34 sites. 34 of the 34 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07449702. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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