Dose Ranging Study of ORKA-002 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-002 in adult participants with moderate-to-severe plaque psoriasis.
Key facts
- Study ID
- NCT07474792
- Run by
- Oruka Therapeutics, Inc.
- People needed
- 160
- Starts
- 2026-03-19
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants ≥ 18 and < 80 years of age at the time of consent
- 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-002 drug product
- Women who are breastfeeding or plan to breastfeed during the study
Where it is running
- Oruka Therapeutics Investigative Site — Birmingham, Alabama, United States (enrolling)
- Oruka Therapeutics Investigative Site — Fountain Valley, 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 — Santa Ana, California, United States (enrolling)
- Oruka Therapeutics Investigative Site — Santa Monica, California, United States (enrolling)
- Oruka Therapeutics Investigative Site — Cromwell, Connecticut, 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 — Milford, Massachusetts, United States (enrolling)
- Oruka Therapeutics Investigative Site — Ann Arbor, Michigan, United States (enrolling)
- Oruka Therapeutics Investigative Site — Detroit, Michigan, United States (enrolling)
- Oruka Therapeutics Investigative Site — Warren, Michigan, United States (enrolling)
- Oruka Therapeutics Investigative Site — New Brighton, Minnesota, United States (enrolling)
- Oruka Therapeutics Investigative Site — Omaha, Nebraska, United States (enrolling)
- Oruka Therapeutics Investigative Site — Elmhurst, New York, United States (enrolling)
- Oruka Therapeutics Investigative Site — New York, New York, United States (enrolling)
- Oruka Therapeutics Investigative Site — Wilmington, North Carolina, United States (enrolling)
- Oruka Therapeutics Investigative Site — Bexley, Ohio, United States (enrolling)
- Oruka Therapeutics Investigative Site — Portland, Oregon, United States (enrolling)
- Oruka Therapeutics Investigative Site — Warrenton, Oregon, United States (enrolling)
- Oruka Therapeutics Investigative Site — Dallas, Texas, United States (enrolling)
- Oruka Therapeutics Investigative Site — Dallas, Texas, United States (enrolling)
- Oruka Therapeutics Investigative Site — Mill Creek, Washington, United States (enrolling)
- Oruka Therapeutics Investigative Site — Edmonton, Alberta, Canada (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.