RecruitingPhase 2NCT07290569
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Sponsor
Oruka Therapeutics, Inc.
Enrollment
160 participants
Start Date
Dec 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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.
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-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
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Interventions
DRUGORKA-001
ORKA-001 administered by subcutaneous (SC) injection
OTHERPlacebo
Placebo administered by subcutaneous (SC) injection
Locations(26)
View Full Details on ClinicalTrials.gov
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NCT07290569
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