A Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics 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
California
Oruka Therapeutics Investigative Site
RECRUITING
Fountain Valley
Oruka Therapeutics Investigative Site
RECRUITING
Los Angeles
Oruka Therapeutics Investigative Site
RECRUITING
San Diego
Oruka Therapeutics Investigative Site
RECRUITING
Santa Ana
Oruka Therapeutics Investigative Site
RECRUITING
Santa Monica
Connecticut
Oruka Therapeutics Investigative Site
RECRUITING
Cromwell
Florida
Oruka Therapeutics Investigative Site
RECRUITING
Coral Gables
Kentucky
Oruka Therapeutics Investigative Site
RECRUITING
Bowling Green
Massachusetts
Oruka Therapeutics Investigative Site
RECRUITING
Boston
Maryland
Oruka Therapeutics Investigative Site
RECRUITING
Rockville
Michigan
Oruka Therapeutics Investigative Site
RECRUITING
Detroit
New York
Oruka Therapeutics Investigative Site
RECRUITING
New York
Oruka Therapeutics Investigative Site
RECRUITING
New York
Oregon
Oruka Therapeutics Investigative Site
RECRUITING
Portland
Wisconsin
Oruka Therapeutics Investigative Site
RECRUITING
Milwaukee
Other Locations
Canada
Oruka Therapeutics Investigative Site
RECRUITING
Hamilton
Oruka Therapeutics Investigative Site
RECRUITING
London
Oruka Therapeutics Investigative Site
RECRUITING
Markham
Oruka Therapeutics Investigative Site
RECRUITING
Peterborough
Oruka Therapeutics Investigative Site
RECRUITING
Surrey
Oruka Therapeutics Investigative Site
RECRUITING
Toronto
Oruka Therapeutics Investigative Site
RECRUITING
Waterloo
Contact Information
Primary
Oruka Clinical Trials Information
clinicaltrials@orukatx.com
781-560-0299
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2027-05
Participants
Target number of participants: 80
Treatments
Experimental: (Induction Period) ORKA-001
Participants will receive ORKA-001 per protocol Induction regimen.
Placebo_comparator: (Induction Period) Placebo
Participants will receive Placebo per protocol Induction regimen.
Experimental: (Maintenance Period - Arm 1) ORKA-001
Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
Experimental: (Maintenance Period - Arm 2) ORKA-001
Participants will receive 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.