Actively Recruiting
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
Led by Oruka Therapeutics, Inc. · Updated on 2026-06-02
240
Participants Needed
22
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety and effectiveness of ORKA-001 in adults with moderate-to-severe plaque psoriasis who have previously participated in an Oruka Therapeutics sponsored study. The study is an open-label extension, focusing on adults who have completed a prior trial and seeks to monitor ongoing effects and safety over an extended period. Participants will receive ORKA-001 through subcutaneous injection following one of several dosing schedules once yearly at a high or low dose, twice yearly, or no drug until a specific response criterion is met. The treatment period can last up to approximately 96 weeks, followed by a post-treatment follow-up of about 48 weeks to observe longer-term outcomes. During the study, participants will be closely monitored for adverse events and treatment responses using measures like the Psoriasis Area and Severity Index PASI and Investigators Global Assessment IGA. Safety evaluations include tracking any serious or special interest adverse events throughout the study period. Participants will have regular visits for assessments, and the total involvement may span over three years, including treatment and follow-up.
CONDITIONS
Brief Title
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
Research Team
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Oruka Clinical Trials Information
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