Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT07290569
- Run by
- Oruka Therapeutics, Inc.
- People needed
- 160
- Starts
- 2025-12-03
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- Oruka Therapeutics Investigative Site — Phoenix, Arizona, United States (enrolling)
- Oruka Therapeutics Investigative Site — North Little Rock, Arkansas, United States (enrolling)
- Oruka Therapeutics Investigative Site — Los Angeles, California, United States (enrolling)
- Oruka Therapeutics Investigative Site — Los Angeles, California, United States (enrolling)
- Oruka Therapeutics Investigative Site — San Diego, California, United States (enrolling)
- Oruka Therapeutics Investigative Site — Miami, Florida, United States (enrolling)
- Oruka Therapeutics Investigative Site — Rolling Meadows, Illinois, United States (enrolling)
- Oruka Therapeutics Investigative Site — Plainfield, Indiana, United States (enrolling)
- Oruka Therapeutics Investigative Site — Rockville, Maryland, United States (enrolling)
- Oruka Therapeutics Investigative Site — Kew Gardens, New York, United States (enrolling)
- Oruka Therapeutics Investigative Site — Chapel Hill, North Carolina, United States (enrolling)
- Oruka Therapeutics Investigative Site — Cleveland, Ohio, United States (enrolling)
- Oruka Therapeutics Investigative Site — Mason, Ohio, United States (enrolling)
- Oruka Therapeutics Investigative Site — Portland, Oregon, United States (enrolling)
- Oruka Therapeutics Investigative Site — Portland, Oregon, United States (enrolling)
- Oruka Therapeutics Investigative Site — Philadelphia, Pennsylvania, United States (enrolling)
- Oruka Therapeutics Investigative Site — Frisco, Texas, United States (enrolling)
- Oruka Therapeutics Investigative Site — Houston, Texas, United States (enrolling)
- Oruka Therapeutics Investigative Site — Webster, Texas, United States (enrolling)
- Oruka Therapeutics Investigative Site — Norfolk, Virginia, United States (enrolling)
- Oruka Therapeutics Investigative Site — Surrey, British Columbia, Canada (enrolling)
- Oruka Therapeutics Investigative Site — Surrey, British Columbia, Canada (enrolling)
- Oruka Therapeutics Investigative Site — Fredericton, New Brunswick, Canada (enrolling)
- Oruka Therapeutics Investigative Site — Ajax, Ontario, Canada (enrolling)
- Oruka Therapeutics Investigative Site — Markham, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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