An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed informed consent by participants from previous trial choosing to transition into the OLE.
• Participants who have successfully completed the preceding trial.
• For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
• For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception
Locations
United States
California
Oruka Therapeutics Investigative Site
RECRUITING
Los Angeles
Oruka Therapeutics Investigative Site
RECRUITING
San Diego
Oruka Therapeutics Investigative Site
RECRUITING
Santa Ana
Florida
Oruka Therapeutics Investigative Site
RECRUITING
Coral Gables
Kentucky
Oruka Therapeutics Investigative Site
RECRUITING
Bowling Green
Maryland
Oruka Therapeutics Investigative Site
RECRUITING
Rockville
New York
Oruka Therapeutics Investigative Site
RECRUITING
New York
Other Locations
Canada
Oruka Therapeutics Investigative Site
RECRUITING
Markham
Oruka Therapeutics Investigative Site
RECRUITING
Peterborough
Oruka Therapeutics Investigative Site
RECRUITING
Surrey
Contact Information
Primary
Oruka Clinical Trials Information
clinicaltrials@orukatx.com
781-560-0299
Time Frame
Start Date: 2026-02-23
Estimated Completion Date: 2029-01
Participants
Target number of participants: 80
Treatments
Experimental: ORKA-001 Once Yearly
Participants will receive ORKA-001 once a year per OLE protocol.
Experimental: ORKA-001 Twice Yearly
Participants will receive ORKA-001 every 6 months per OLE protocol.
No_intervention: No Drug
Participants will receive no drug until protocol defined PASI response criterion is met.
Related Therapeutic Areas
Sponsors
Leads: Oruka Therapeutics, Inc.