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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07449702 | An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis | PHASE2 | RECRUITING | 240 | — | — | Feb 23, 2026 | Jul 1, 2030 | Jun 2, 2026 | 22 | United States, Canada |
| NCT07290569 | Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis | PHASE2 | RECRUITING | 160 | — | — | Dec 3, 2025 | Dec 1, 2028 | Jun 2, 2026 | 36 | United States, Canada +2 |
| NCT07090330 | ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis | PHASE2 | ACTIVE NOT_RECRUITING | 80 | — | — | Jul 18, 2025 | May 1, 2027 | Mar 17, 2026 | 26 | United States, Canada |
Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.
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).
| Arm | Type | Description |
|---|---|---|
| ORKA-001 Once Yearly (High Dose) | EXPERIMENTAL | Participants will receive ORKA-001 once a year per OLE protocol. |
| ORKA-001 Once Yearly (Low Dose) | EXPERIMENTAL | Participants will receive ORKA-001 once a year per OLE protocol. |
| ORKA-001 Twice Yearly | EXPERIMENTAL | Participants will receive ORKA-001 every 6 months per OLE protocol. |
| No Drug | NO_INTERVENTION | Participants will receive no drug until protocol defined PASI response criterion is met. |
| (Induction Period - Arm 1) ORKA-001 | EXPERIMENTAL | Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen. |
| (Induction Period - Arm 2) ORKA-001 | EXPERIMENTAL | Participants will receive 300 mg ORKA-001 per protocol Induction regimen. |
| (Induction Period - Arm 3) ORKA-001 | EXPERIMENTAL | Participants will receive 600 mg ORKA-001 per protocol Induction regimen. |
| (Induction Period - Arm 4) Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo per protocol Induction regimen. |
| (Maintenance Period - Arm 1) ORKA-001 | EXPERIMENTAL | Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
| (Maintenance Period - Arm 2) ORKA-001 | EXPERIMENTAL | Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
| (Maintenance Period - Arm 3) Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response. |
| (Induction Period) ORKA-001 | EXPERIMENTAL | Participants will receive ORKA-001 per protocol Induction regimen. |
| (Induction Period) Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo per protocol Induction regimen. |
| Name | Type | Description |
|---|---|---|
| ORKA-001 | DRUG | ORKA-001 administered by subcutaneous (SC) injection |
| Placebo | OTHER | Placebo administered by subcutaneous (SC) injection |
| ORKA-001 Induction Dose | DRUG | ORKA-001 Induction Dose, administered by subcutaneous (SC) injection |
| ORKA-001 Maintenance Dose | DRUG | ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection |
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 wo...