Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
Recruiting · NCT07474792 · Interventional (participants receive a specific treatment) · Lead sponsor: Oruka Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ORKA-002Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
39 locations listed across 17 US states.
- Oruka Therapeutics Investigative Site - Birmingham, Alabama, United States
- Oruka Therapeutics Investigative Site - Phoenix, Arizona, United States
- Oruka Therapeutics Investigative Site - Fountain Valley, 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 - Santa Ana, California, United States
- Oruka Therapeutics Investigative Site - Santa Monica, California, United States
- Oruka Therapeutics Investigative Site - Cromwell, Connecticut, United States
- Oruka Therapeutics Investigative Site - Miami, Florida, United States
- Oruka Therapeutics Investigative Site - Rolling Meadows, Illinois, United States
- Oruka Therapeutics Investigative Site - Boston, Massachusetts, United States
- Oruka Therapeutics Investigative Site - Milford, Massachusetts, United States
- Oruka Therapeutics Investigative Site - Ann Arbor, Michigan, United States
- Oruka Therapeutics Investigative Site - Detroit, Michigan, United States
- Oruka Therapeutics Investigative Site - Warren, Michigan, United States
- Oruka Therapeutics Investigative Site - New Brighton, Minnesota, United States
- Oruka Therapeutics Investigative Site - Omaha, Nebraska, United States
- Oruka Therapeutics Investigative Site - Elmhurst, New York, United States
- Oruka Therapeutics Investigative Site - New York, New York, United States
- Oruka Therapeutics Investigative Site - Wilmington, North Carolina, United States
- Oruka Therapeutics Investigative Site - Bexley, Ohio, United States
- Oruka Therapeutics Investigative Site - Portland, Oregon, United States
- Oruka Therapeutics Investigative Site - Warrenton, Oregon, United States
- Oruka Therapeutics Investigative Site - Charleston, South Carolina, United States
- Oruka Therapeutics Investigative Site - Dallas, Texas, United States
- Oruka Therapeutics Investigative Site - Dallas, Texas, United States
- Oruka Therapeutics Investigative Site - Houston, Texas, United States
- Oruka Therapeutics Investigative Site - Webster, Texas, United States
- Oruka Therapeutics Investigative Site - Mill Creek, Washington, United States
- Oruka Therapeutics Investigative Site - Edmonton, Alberta, Canada
- Oruka Therapeutics Investigative Site - Edmonton, Alberta, Canada
- Oruka Therapeutics Investigative Site - Surrey, British Columbia, Canada
- Oruka Therapeutics Investigative Site - Barrie, Ontario, Canada
- Oruka Therapeutics Investigative Site - London, Ontario, Canada
- Oruka Therapeutics Investigative Site - North Bay, Ontario, Canada
- Oruka Therapeutics Investigative Site - Peterborough, Ontario, Canada
- Oruka Therapeutics Investigative Site - Toronto, Ontario, Canada
- Oruka Therapeutics Investigative Site - Waterloo, Ontario, Canada
- Oruka Therapeutics Investigative Site - Saskatoon, Saskatchewan, Canada