The total duration of this study for each participant is approximately 144 weeks, which includes an OLE Period of up to approximately 96 weeks followed by a Post-treatment Follow-up Period of approximately 48 weeks following the last visit.
Psoriasis
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
Psoriasis
All genders
18+
Recruiting now
Overview
Principal Investigator: Jeffrey Sobell, MD
Contact Us
Alysha Zipeto
Study details
Inclusion Criteria
- Participants who have successfully completed the preceding trial (ORKA-001-112). Successful completion of preceding trial is defined as either: participants initially randomized to placebo who completed Week 28 or participants initially randomized to ORKA-001 who completed Week 52.
Exclusion Criteria
- Participants who experienced any adverse events with ORKA-001 in the preceding trial (ORKA-001-112) that, in the opinion of the Investigator, would preclude continued treatment with ORKA-001.
- Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
Study Requirements
The study duration will be approximately 144 weeks with 14 on site study visits