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: * Screening Period * Induction Period * Post-treatment Follow-up Period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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).
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Oruka Therapeutics Investigative Site
Birmingham, Alabama, United States
RECRUITINGOruka Therapeutics Investigative Site
Phoenix, Arizona, United States
RECRUITINGOruka Therapeutics Investigative Site
Fountain Valley, California, United States
RECRUITINGOruka Therapeutics Investigative Site
Los Angeles, California, United States
RECRUITINGOruka Therapeutics Investigative Site
San Diego, California, United States
RECRUITINGOruka Therapeutics Investigative Site
Santa Ana, California, United States
RECRUITINGOruka Therapeutics Investigative Site
Santa Monica, California, United States
RECRUITINGOruka Therapeutics Investigative Site
Cromwell, Connecticut, United States
RECRUITINGOruka Therapeutics Investigative Site
Miami, Florida, United States
RECRUITINGOruka Therapeutics Investigative Site
Rolling Meadows, Illinois, United States
RECRUITING...and 29 more locations
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