NCT07449702 An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
| NCT ID | NCT07449702 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oruka Therapeutics, Inc. |
| Condition | Plaque Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2026-02-23 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07449702 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Plaque Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07449702 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07449702 currently recruiting?
Yes, NCT07449702 is actively recruiting participants. Contact the research team at clinicaltrials@orukatx.com for enrollment information.
Where is the NCT07449702 trial being conducted?
This trial is being conducted at Phoenix, United States, Fountain Valley, United States, Los Angeles, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT07449702 clinical trial?
NCT07449702 is sponsored by Oruka Therapeutics, Inc.. The trial plans to enroll 240 participants.
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