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 the treatment of moderate-to-severe plaque psoriasis. It is also being studied in healthy volunteers to assess its safety and tolerability. The drug is currently in clinical development and has not been approved by regulatory authorities.
ORKA-001 targets IL-23p19, a subunit of the cytokine interleukin-23. By targeting this molecule, the drug aims to modulate the inflammatory pathway involved in plaque psoriasis. This mechanism is being evaluated in clinical trials to determine its efficacy and safety in patients.
ORKA-001 is being developed by Oruka Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with plaque psoriasis and in healthy volunteers.
ORKA-001 is in Phase 2 clinical development. It has completed a Phase 1 trial in healthy volunteers and is currently being evaluated in Phase 2 trials for moderate-to-severe plaque psoriasis. The drug is investigational and has not received regulatory approval.
ORKA-001 is being studied in several clinical trials, including NCT07090330, a Phase 2 placebo-controlled trial in patients with moderate-to-severe plaque psoriasis, and NCT07290569, a Phase 2 dose-ranging study. An open-label extension study, NCT07449702, is also recruiting participants. A Phase 1 trial in healthy volunteers, NCT06698939, has been completed.
Yes, ORKA-001 is also known as ORKA-001 Induction Dose. This alternative name may be used in clinical trial contexts to refer to the initial dosing regimen of the drug. Both names refer to the same investigational small molecule being developed for plaque psoriasis.