In short
ORKA-001 is an investigational medicine being studied for moderate-to-severe plaque psoriasis. Two Phase 2 clinical trials are currently authorised: one dose-ranging study with 160 participants comparing ORKA-001 against placebo, and one open-label extension study with 240 participants evaluating long-term safety. Both trials use a 600 mg subcutaneous injection.
ORKA-001 is an investigational medicine being studied for moderate-to-severe plaque psoriasis. It has not yet received marketing authorisation and is currently being evaluated in two Phase 2 clinical trials.
Key points
- ORKA-001 is an investigational medicine studied in moderate-to-severe plaque psoriasis.
- Two Phase 2 clinical trials are authorised.
- The dose-ranging study enrolled 160 participants and compares ORKA-001 with placebo.
- The open-label extension study enrolled 240 participants to assess long-term safety.
- Both trials use a 600 mg subcutaneous injection.
- The main efficacy measure is the PASI score, which rates psoriasis severity from 0 to 72.
What is ORKA-001?
ORKA-001 is an investigational medicine being studied for the treatment of moderate-to-severe plaque psoriasis. It is given as a subcutaneous injection at a dose of 600 mg. The available registry data do not provide information about the chemical class, mechanism of action, or pharmaceutical form of ORKA-001 beyond the route of administration.
How does ORKA-001 work?
The available sources do not describe the mechanism of action of ORKA-001. The clinical trial records describe the evaluation of its efficacy and safety in plaque psoriasis but do not explain how the medicine acts in the body.
Which conditions is it used or studied for?
- Moderate-to-severe plaque psoriasis — a chronic skin condition in which thick, scaly patches form on the skin. Both authorised trials of ORKA-001 are studying this condition.
How is ORKA-001 given?
ORKA-001 is given as a subcutaneous injection at a dose of 600 mg. This is an injection under the skin. No other pharmaceutical forms are described in the available data.
What do the clinical trials show?
Two Phase 2 clinical trials of ORKA-001 are authorised. Both are interventional studies in moderate-to-severe plaque psoriasis. The first trial (NCT07290569) is a dose-ranging study that compares ORKA-001 with placebo and enrolled 160 participants. Its primary outcome is the proportion of participants achieving a 100% reduction in the Psoriasis Area and Severity Index (PASI) score at week 16. The PASI score ranges from 0 (no disease) to 72 (maximum disease). The second trial (NCT07449702) is an open-label extension study that enrolled 240 participants. Its primary outcome is the incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and changes in vital signs, laboratory parameters, and electrocardiograms.
What are the trials measuring?
The dose-ranging study measures efficacy using the proportion of participants achieving a 100% reduction in PASI score at week 16. The open-label extension study measures long-term safety, including adverse events, serious adverse events, and changes in vital signs, laboratory parameters, and electrocardiograms.
Who can take part in these trials?
Both trials include participants with moderate-to-severe plaque psoriasis. The dose-ranging study enrolled 160 participants, and the open-label extension study enrolled 240 participants. The available records do not specify additional inclusion or exclusion criteria.
What side effects are known?
The available sources do not provide information about the side effects of ORKA-001. The open-label extension study is specifically designed to evaluate long-term safety, including adverse events and serious adverse events, but no specific side effects are reported in the registry data.