after signing the consent form, the patient attends the enrollment visit.

the medical team records personal data, medical history and the severity of moderate-to-severe plaque psoriasis.

baseline measurements such as the psoriasis area and severity index (pasi) and the investigator global assessment (iga) are taken.

the patient is randomly assigned to receive either orka-001 or a placebo. the assignment is double‑blinded, so neither the patient nor the staff knows which product is given.

on day 1, a single subcutaneous injection (injection under the skin) is given.

the injection contains 600 mg of orka-001 dissolved in a solution for injection, or an identical‑looking placebo.

the injection is performed by a qualified professional in a clinical setting.

four weeks after the first injection, the patient returns for a safety visit.

vital signs, laboratory tests and any adverse events that occurred since the injection are recorded.

no additional dose is given unless the protocol specifies a repeat dose, which is not indicated in the provided information.

at week 8, the patient undergoes another clinical evaluation.

the psoriasis area and severity index and the investigator global assessment are measured again to monitor changes.

at week 16, the main study outcomes are evaluated.

the proportion of patients who achieve a 100 % reduction in the psoriasis area and severity index (pasi 100) is recorded.

the proportion of patients with an investigator global assessment score of 0 (clear) is recorded.

additional secondary outcomes such as a 90 % reduction in pasi and an iga score of 0 or 1 (clear or almost clear) are also documented.

the patient continues regular visits approximately every 12 weeks until week 100.

at each visit, the psoriasis area and severity index and the investigator global assessment are measured to assess the durability of the response.

the study records whether the patient maintains a 100 % reduction in pasi, a 90 % reduction, a 75 % reduction, and whether the iga remains at 0 or 0/1.

adverse events are monitored continuously from day 1 through week 100.