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
Oruka Therapeutics, Inc.
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.
Description
This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent by participants from previous trial choosing to transition into the OLE. 2. Participants who have successfully completed the preceding trial. 3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit. 4. 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 Exclusion Criteria: 1. Participants who experienced any adverse events with ORKA-001 in the preceding trial that, in the opinion of…
Interventions
- DrugORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Locations (17)
- Oruka Therapeutics Investigative SiteLos Angeles, California
- Oruka Therapeutics Investigative SiteSan Diego, California
- Oruka Therapeutics Investigative SiteSanta Ana, California
- Oruka Therapeutics Investigative SiteSanta Monica, California
- Oruka Therapeutics Investigative SiteCromwell, Connecticut
- Oruka Therapeutics Investigative SiteCoral Gables, Florida