NCT07474792 Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
| NCT ID | NCT07474792 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oruka Therapeutics, Inc. |
| Condition | Plaque Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2027-10 |
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 160 participants in total. It began in 2026-03-19 with a primary completion date of 2027-10.
⚠ 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
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.
Eligibility Criteria
Inclusion Criteria: 1. Participants ≥ 18 and \< 80 years of age at the time of consent 2. Have a diagnosis of plaque psoriasis for \> 6 months 3. Have moderate-to-severe chronic plaque psoriasis defined as: 1. BSA ≥ 10%, and 2. PASI ≥ 12, and 3. IGA score of ≥ 3 on a 5-point scale 4. Candidate for systemic therapy or phototherapy 5. Women of childbearing potential must have a negative pregnancy test Exclusion Criteria: 1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis) 2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease 3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence 4. A known hypersensitivity to any components of the ORKA-002 drug product 5. Women who are breastfeeding or plan to breastfeed during the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07474792 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, 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 NCT07474792 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 NCT07474792 currently recruiting?
Yes, NCT07474792 is actively recruiting participants. Contact the research team at clinicaltrials@orukatx.com for enrollment information.
Where is the NCT07474792 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Fountain Valley, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT07474792 clinical trial?
NCT07474792 is sponsored by Oruka Therapeutics, Inc.. The trial plans to enroll 160 participants.
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