Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis
Oruka Therapeutics, Inc.
160 participants
Mar 19, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria5
- 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
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Interventions
ORKA-002 administered by subcutaneous (SC) injection
Placebo administered by subcutaneous (SC) injection
Locations(27)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07474792