Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

Condition(s) studied

Investigational drug(s) / intervention(s)

ORKA-002: ORKA-002 administered by subcutaneous (SC) injection

Placebo: Placebo administered by subcutaneous (SC) injection

Study summary

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.

Eligibility

Primary outcome measure(s)

• Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 — Week 16
  The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
• Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs) — Day 1 through Week 48
  Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms

Trial sites (39)