Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07474792 | Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis | PHASE2 | RECRUITING | 160 | — | — | Mar 19, 2026 | Apr 1, 2029 | May 27, 2026 | 31 | United States, Canada |
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), 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
| Arm | Type | Description |
|---|---|---|
| (Induction Period - Arm 1) ORKA-002 | EXPERIMENTAL | Participants will receive ORKA-002 per protocol Induction regimen. |
| (Induction Period - Arm 2) ORKA-002 | EXPERIMENTAL | Participants will receive ORKA-002 per protocol Induction regimen. |
| (Induction Period - Arm 3) ORKA-002 | EXPERIMENTAL | Participants will receive ORKA-002 per protocol Induction regimen. |
| (Induction Period - Arm 4) Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo per protocol Induction regimen. |
| Name | Type | Description |
|---|---|---|
| ORKA-002 | DRUG | ORKA-002 administered by subcutaneous (SC) injection |
| Placebo | OTHER | Placebo administered by subcutaneous (SC) injection |
Inclusion Criteria: 1. Participants ≥ 18 and \< 80 years of age at the time of consent 2. Have a diagnosis of plaque psoriasis for \> 6 months 3. Have moderate-to-severe chronic plaque psoriasis defined as: 1. BSA ≥ 10%, and 2. PASI ≥ 12, and 3. IGA score of ≥ 3 on a 5-point scale 4. Cand...