Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORKA-002 · 2 trials · 2 indications
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
Incidence of treatment-emergent adverse events and clinically significant changes from baseline in vital signs, electrocardiograms, and clinical laboratory parameters
| 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. |
| ORKA-002 | EXPERIMENTAL | Subcutaneous (SC) injection of ORKA-002 |
| Placebo | PLACEBO_COMPARATOR | Subcutaneous (SC) injection of placebo comparator |
| 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...
ORKA-002 is an investigational small molecule being developed for moderate-to-severe plaque psoriasis. It is also being studied in healthy volunteers to evaluate safety and tolerability. The drug is currently in Phase 1 and Phase 2 clinical trials.
ORKA-002 targets IL-17A/F, a cytokine involved in inflammatory responses. By modulating this pathway, the drug aims to reduce inflammation associated with plaque psoriasis. It is classified as an antibody-based therapy despite being a small molecule.
ORKA-002 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 treating plaque psoriasis and in healthy volunteers.
ORKA-002 is in Phase 1 and Phase 2 clinical development. A Phase 1 study in healthy volunteers is active but not recruiting, while a Phase 2 dose-ranging study in patients with moderate-to-severe plaque psoriasis is currently recruiting.
ORKA-002 is being studied in two trials. NCT06944379 is a Phase 1 single-dose study in healthy volunteers in New Zealand. NCT07474792 is a Phase 2 dose-ranging study in patients with plaque psoriasis in the United States and Canada.
ORKA-002 is a unique investigational drug with no alternative names listed. It is being developed specifically for plaque psoriasis and is not known to be identical to any other approved or investigational therapy.