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A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
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.
This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 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-001 compared to placebo and will include 3 maintenance regimens. The study will consist of 4 periods: * Screening Period of up to 6 weeks * Induction Period of up to 28 weeks (Day 1 \[Baseline\] to Week 28) * Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100) * Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Oruka Therapeutics Investigative Site
Phoenix, Arizona, United States
Oruka Therapeutics Investigative Site
North Little Rock, Arkansas, United States
Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Oruka Therapeutics Investigative Site
Coral Gables, Florida, United States
Oruka Therapeutics Investigative Site
Rolling Meadows, Illinois, United States
Oruka Therapeutics Investigative Site
Plainfield, Indiana, United States
Oruka Therapeutics Investigative Site
Rockville, Maryland, United States
Oruka Therapeutics Investigative Site
Kew Gardens, New York, United States
Oruka Therapeutics Investigative Site
Chapel Hill, North Carolina, United States
Start Date
December 3, 2025
Primary Completion Date
June 1, 2027
Completion Date
December 1, 2028
Last Updated
March 2, 2026
160
ESTIMATED participants
ORKA-001
DRUG
Placebo
OTHER
Lead Sponsor
Oruka Therapeutics, Inc.
NCT07116967
NCT07250802
NCT07449702
Data Source & Attribution
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