A Phase 2 interventional study of ORKA-002 and Placebo in Plaque Psoriasis, sponsored by Oruka Therapeutics, Inc.. Recruiting at 39 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Oruka Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
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:
Oruka Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Have moderate-to-severe chronic plaque psoriasis defined as:
Exclusion Criteria:
Participants will receive ORKA-002 per protocol Induction regimen.
Drug: ORKA-002
Participants will receive ORKA-002 per protocol Induction regimen.
Drug: ORKA-002
Participants will receive ORKA-002 per protocol Induction regimen.
Drug: ORKA-002
Participants will receive Placebo per protocol Induction regimen.
Other: Placebo
ORKA-002 administered by subcutaneous (SC) injection
Placebo administered by subcutaneous (SC) injection
Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16
The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
Time frame: Week 16
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs)
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Time frame: Day 1 through Week 48
Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16
The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Time frame: Week 16
Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16
Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
Time frame: Week 16
Proportion of Participants Who Achieve an IGA=0 (Clear) or 1 (Almost Clear) at Week 16
Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
Time frame: Week 16
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of Special Interest (TEAESIs)
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Time frame: Day 1 through Week 48
Plan to share: Undecided
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Oruka Therapeutics, Inc.