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Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

NCT07474792 · Oruka Therapeutics, Inc.
In plain English

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Official title
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
About this study
This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis. The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo. The study will consist of 3 periods: * Screening Period * Induction Period * Post-treatment Follow-up Period
Eligibility criteria
Inclusion Criteria: 1. Participants ≥ 18 and \< 80 years of age at the time of consent 2. Have a diagnosis of plaque psoriasis for \> 6 months 3. Have moderate-to-severe chronic plaque psoriasis defined as: 1. BSA ≥ 10%, and 2. PASI ≥ 12, and 3. IGA score of ≥ 3 on a 5-point scale 4. Candidate for systemic therapy or phototherapy 5. Women of childbearing potential must have a negative pregnancy test Exclusion Criteria: 1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis) 2. 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 3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence 4. A known hypersensitivity to any components of the ORKA-002 drug product 5. Women who are breastfeeding or plan to breastfeed during the study
Study design
Enrollment target: 160 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-19
Estimated completion: 2029-04
Last updated: 2026-05-27
Interventions
Drug: ORKA-002Other: Placebo
Primary outcomes
  • Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 (Week 16)
  • Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs) (Day 1 through Week 48)
Sponsor
Oruka Therapeutics, Inc. · industry
Contacts & investigators
ContactOruka Clinical Trials Information · contact · clinicaltrials@orukatx.com · 781-560-0299
All locations (31)
Oruka Therapeutics Investigative SiteRecruiting
Birmingham, Alabama, United States
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Fountain Valley, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Santa Monica, California, United States
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Cromwell, Connecticut, United States
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Coral Gables, Florida, United States
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Milford, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Warren, Michigan, United States
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New Brighton, Minnesota, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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Wilmington, North Carolina, United States
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Bexley, Ohio, United States
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Portland, Oregon, United States
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Warrenton, Oregon, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Mill Creek, Washington, United States
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Edmonton, Alberta, Canada
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Surrey, British Columbia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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North Bay, Ontario, Canada
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Peterborough, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis · TrialPath