RecruitingPhase 2NCT07449702

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

Sponsor

Oruka Therapeutics, Inc.

Enrollment

80 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Plaque Psoriasis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria5

Participants who experienced any adverse events with ORKA-001 in the preceding trial that, 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.

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