Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ORKA-001 Induction Dose
ORKA-001 · 4 trials · 2 indications
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).
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, and physical examinations.
| 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. |
| ORKA-001 | EXPERIMENTAL | Participants will receive subcutaneous injection of ORKA-001 at either 300 mg, 600 mg or 1200 mg. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a subcutaneous injection of placebo comparator. |
| 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...
ORKA-001 is an investigational small molecule being developed for plaque psoriasis, specifically moderate-to-severe plaque psoriasis. It is also studied in healthy volunteers for safety and tolerability. The drug is not yet approved and is currently in clinical development, with trials enrolling adults aged 18 years and older.
ORKA-001 targets IL-23p19, a subunit of the cytokine interleukin-23. By targeting IL-23p19, the drug aims to modulate the inflammatory pathway involved in plaque psoriasis. This mechanism is being evaluated in clinical trials for moderate-to-severe plaque psoriasis.
ORKA-001 is developed by Oruka Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials for the drug in healthy volunteers and patients with plaque psoriasis. Oruka Therapeutics is publicly traded under the ticker ORKA.
ORKA-001 is in Phase 2 clinical development. It has completed a Phase 1 trial in healthy volunteers and is currently in multiple Phase 2 trials for moderate-to-severe plaque psoriasis. The drug is investigational and has not received FDA approval.
ORKA-001 has several clinical trials: NCT06698939, a completed Phase 1 study in healthy volunteers in New Zealand; NCT07090330, an active Phase 2 placebo-controlled trial in plaque psoriasis in the US and Canada; NCT07290569, an active Phase 2 dose-ranging study in the US, Canada, Germany, and Spain; and NCT07449702, a recruiting open-label extension study in the US and Canada.
Yes, ORKA-001 is also known as ORKA-001 Induction Dose. This alternative name refers to the same investigational drug being developed by Oruka Therapeutics for plaque psoriasis. The drug is being studied in multiple clinical trials under the name ORKA-001.