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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Signed willing to sign a consent form 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 Who Should NOT Join This Trial: 1. 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 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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, 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.

Treatments Being Tested

DRUG

ORKA-001

ORKA-001 administered by subcutaneous (SC) injection

Locations (10)

Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Oruka Therapeutics Investigative Site
San Diego, California, United States
Oruka Therapeutics Investigative Site
Santa Ana, California, United States
Oruka Therapeutics Investigative Site
Coral Gables, Florida, United States
Oruka Therapeutics Investigative Site
Bowling Green, Kentucky, United States
Oruka Therapeutics Investigative Site
Rockville, Maryland, United States
Oruka Therapeutics Investigative Site
New York, New York, United States
Oruka Therapeutics Investigative Site
Surrey, British Columbia, Canada
Oruka Therapeutics Investigative Site
Markham, Ontario, Canada
Oruka Therapeutics Investigative Site
Peterborough, Ontario, Canada