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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

Sponsor: Oruka Therapeutics, Inc. · Participants: 240 · Started: Feb 23, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07449702

Locations in the U.S.

ArizonaOruka Therapeutics Investigative Site, Phoenix
CaliforniaOruka Therapeutics Investigative Site, Fountain Valley
Oruka Therapeutics Investigative Site, Los Angeles
Oruka Therapeutics Investigative Site, San Diego
Oruka Therapeutics Investigative Site, Santa Ana
Oruka Therapeutics Investigative Site, Santa Monica
ConnecticutOruka Therapeutics Investigative Site, Cromwell
FloridaOruka Therapeutics Investigative Site, Miami
IllinoisOruka Therapeutics Investigative Site, Rolling Meadows
KentuckyOruka Therapeutics Investigative Site, Bowling Green
MarylandOruka Therapeutics Investigative Site, Rockville
MassachusettsOruka Therapeutics Investigative Site, Boston
MichiganOruka Therapeutics Investigative Site, Detroit
New YorkOruka Therapeutics Investigative Site, New York
Oruka Therapeutics Investigative Site, New York
OhioOruka Therapeutics Investigative Site, Mason
OregonOruka Therapeutics Investigative Site, Portland
Oruka Therapeutics Investigative Site, Portland
TexasOruka Therapeutics Investigative Site, Frisco
Oruka Therapeutics Investigative Site, Houston
Oruka Therapeutics Investigative Site, Webster
VirginiaOruka Therapeutics Investigative Site, Norfolk

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.