An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis (NCT07449702) | Clinical Trial Compass
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
United States, Canada240 participantsStarted 2026-02-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)