The total duration of this study for each participant is approximately 34 weeks, which includes a screening period of 6 weeks, followed by a 28-week induction period. Subjects not achieving PASI 100 at Week 28, will be transitioned to open label fixed dose in a OLE study. Subjects who achieve PASI 100 at Week 28 will be re-randomized to fixed dose or placebo at a ratio of 1:2 and continue to Week 52. At Week 52, subjects have option to roll into OLE study.
Psoriasis
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
Psoriasis
All genders
18+
Recruiting now
Overview
Principal Investigator: Jeffrey Sobell, MD
Contact Us
Alysha Zipeto
Study details
Inclusion Criteria
Total BSA ≥10% at screening and baseline
Total PASI ≥12 at screening and baseline.
Total IGA ≥3 at screening and baseline.
Exclusion Criteria
- Nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
- Primary failure, as per Investigator’s assessment, on > 2 prior biologics.
- Use of prior IL-23 p19 inhibitors (risankizumab, guselkumab, tildrakizumab).
Study Requirements
The study duration will be approximately 34 weeks with 13 study visits if subject does not achieve PASI 100 at Week 28. The study duration will be approximately 28 weeks with 16 study visits if subject achieves PASI 100 at Week 28.