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

NCT07449702 · Oruka Therapeutics, Inc.
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Official title
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
About this study
This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.
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.
Study design
Enrollment target: 240 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-23
Estimated completion: 2030-07
Last updated: 2026-06-02
Interventions
Drug: ORKA-001
Primary outcomes
  • Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs) (Day 1 through Week 144)
Sponsor
Oruka Therapeutics, Inc. · industry
Contacts & investigators
ContactOruka Clinical Trials Information · contact · clinicaltrials@orukatx.com · 781-560-0299
All locations (22)
Oruka Therapeutics Investigative SiteRecruiting
Fountain Valley, California, United States
Oruka Therapeutics Investigative SiteRecruiting
Los Angeles, California, United States
Oruka Therapeutics Investigative SiteRecruiting
San Diego, California, United States
Oruka Therapeutics Investigative SiteRecruiting
Santa Ana, California, United States
Oruka Therapeutics Investigative SiteRecruiting
Santa Monica, California, United States
Oruka Therapeutics Investigative SiteRecruiting
Cromwell, Connecticut, United States
Oruka Therapeutics Investigative SiteRecruiting
Coral Gables, Florida, United States
Oruka Therapeutics Investigative SiteRecruiting
Rolling Meadows, Illinois, United States
Oruka Therapeutics Investigative SiteRecruiting
Bowling Green, Kentucky, United States
Oruka Therapeutics Investigative SiteRecruiting
Rockville, Maryland, United States
Oruka Therapeutics Investigative SiteRecruiting
Boston, Massachusetts, United States
Oruka Therapeutics Investigative SiteRecruiting
Detroit, Michigan, United States
Oruka Therapeutics Investigative SiteRecruiting
New York, New York, United States
Oruka Therapeutics Investigative SiteRecruiting
New York, New York, United States
Oruka Therapeutics Investigative SiteRecruiting
Portland, Oregon, United States
Oruka Therapeutics Investigative SiteRecruiting
Norfolk, Virginia, United States
Oruka Therapeutics Investigative SiteRecruiting
Surrey, British Columbia, Canada
Oruka Therapeutics Investigative SiteRecruiting
London, Ontario, Canada
Oruka Therapeutics Investigative SiteRecruiting
Markham, Ontario, Canada
Oruka Therapeutics Investigative SiteRecruiting
Peterborough, Ontario, Canada
Oruka Therapeutics Investigative SiteRecruiting
Toronto, Ontario, Canada
Oruka Therapeutics Investigative SiteRecruiting
Waterloo, Ontario, Canada
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis · TrialPath