A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Oruka Therapeutics Investigative Site
RECRUITING
North Little Rock
Arizona
Oruka Therapeutics Investigative Site
RECRUITING
Phoenix
California
Oruka Therapeutics Investigative Site
RECRUITING
Los Angeles
Oruka Therapeutics Investigative Site
RECRUITING
Los Angeles
Oruka Therapeutics Investigative Site
RECRUITING
San Diego
Florida
Oruka Therapeutics Investigative Site
RECRUITING
Coral Gables
Illinois
Oruka Therapeutics Investigative Site
RECRUITING
Rolling Meadows
Indiana
Oruka Therapeutics Investigative Site
RECRUITING
Plainfield
Maryland
Oruka Therapeutics Investigative Site
RECRUITING
Rockville
North Carolina
Oruka Therapeutics Investigative Site
RECRUITING
Chapel Hill
New York
Oruka Therapeutics Investigative Site
RECRUITING
Kew Gardens
Ohio
Oruka Therapeutics Investigative Site
RECRUITING
Cleveland
Oruka Therapeutics Investigative Site
RECRUITING
Mason
Oregon
Oruka Therapeutics Investigative Site
RECRUITING
Portland
Oruka Therapeutics Investigative Site
RECRUITING
Portland
Pennsylvania
Oruka Therapeutics Investigative Site
RECRUITING
Philadelphia
Texas
Oruka Therapeutics Investigative Site
RECRUITING
Frisco
Oruka Therapeutics Investigative Site
RECRUITING
Houston
Oruka Therapeutics Investigative Site
RECRUITING
Webster
Virginia
Oruka Therapeutics Investigative Site
RECRUITING
Norfolk
Other Locations
Canada
Oruka Therapeutics Investigative Site
RECRUITING
Ajax
Oruka Therapeutics Investigative Site
RECRUITING
Fredericton
Oruka Therapeutics Investigative Site
RECRUITING
Montreal
Oruka Therapeutics Investigative Site
RECRUITING
Peterborough
Oruka Therapeutics Investigative Site
RECRUITING
Québec
Oruka Therapeutics Investigative Site
RECRUITING
Surrey
Contact Information
Primary
Oruka Clinical Trials Information
clinicaltrials@orukatx.com
781-560-0299
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2028-12
Participants
Target number of participants: 160
Treatments
Experimental: (Induction Period - Arm 1) ORKA-001
Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.
Experimental: (Induction Period - Arm 2) ORKA-001
Participants will receive 300 mg ORKA-001 per protocol Induction regimen.
Experimental: (Induction Period - Arm 3) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Induction regimen.
Placebo_comparator: (Induction Period - Arm 4) Placebo
Participants will receive Placebo per protocol Induction regimen.
Experimental: (Maintenance Period - Arm 1) ORKA-001
Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
Experimental: (Maintenance Period - Arm 2) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
Placebo_comparator: (Maintenance Period - Arm 3) Placebo
Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.
Related Therapeutic Areas
Sponsors
Leads: Oruka Therapeutics, Inc.