Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Recruiting now Phase 2 NCT07290569
Run by Oruka Therapeutics, Inc. · for 18 and older · All sexes
What this study is about
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Who can join (things the study team will check)
✅ You may be able to join if…
- Participants ≥ 18 years of age
- Have a diagnosis of plaque psoriasis for > 6 months
- Have moderate-to-severe chronic plaque psoriasis defined as:
- BSA ≥ 10%, and
- PASI ≥ 12, and
- IGA score of ≥ 3 on a 5-point scale
- Candidate for systemic therapy or phototherapy
- Women of childbearing potential must have a negative pregnancy test.
🚫 You may not be able to join if…
- Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
- 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
- History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
- A known hypersensitivity to any components of the ORKA-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
Where this trial is running
- Oruka Therapeutics Investigative Site, Phoenix, Arizona, United States
- Oruka Therapeutics Investigative Site, North Little Rock, Arkansas, United States
- Oruka Therapeutics Investigative Site, Los Angeles, California, United States
- Oruka Therapeutics Investigative Site, Los Angeles, California, United States
- Oruka Therapeutics Investigative Site, San Diego, California, United States
- Oruka Therapeutics Investigative Site, Miami, Florida, United States
- Oruka Therapeutics Investigative Site, Rolling Meadows, Illinois, United States
- Oruka Therapeutics Investigative Site, Plainfield, Indiana, United States
- Oruka Therapeutics Investigative Site, Rockville, Maryland, United States
- Oruka Therapeutics Investigative Site, Kew Gardens, New York, United States
- Oruka Therapeutics Investigative Site, Chapel Hill, North Carolina, United States
- Oruka Therapeutics Investigative Site, Cleveland, Ohio, United States
+ 24 more sites.
Who to contact
Oruka Clinical Trials Information · 781-560-0299 · clinicaltrials@orukatx.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07290569.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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