ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

Launched by ORUKA THERAPEUTICS, INC. · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called ORKA-001 to see if it can help adults with moderate-to-severe plaque psoriasis, a skin condition that causes red, scaly patches. The study is designed to compare ORKA-001 with a placebo (a harmless pill with no medicine) to find out if ORKA-001 is safe, well-tolerated, and effective in improving psoriasis symptoms.

Adults aged 18 and older who have had plaque psoriasis for more than six months and have a moderate-to-severe form of the disease may be eligible. To join, participants need to have enough skin affected (at least 10% of their body), a certain severity of symptoms, and be suitable for treatments like systemic therapy or light therapy. Women who could become pregnant must have a negative pregnancy test and cannot be breastfeeding during the study. Participants will be randomly assigned to receive either ORKA-001 or the placebo, and neither they nor the doctors will know which one they get until the study ends. This helps make the results more reliable. The study is currently recruiting people interested in helping find better treatments for plaque psoriasis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants ≥ 18 years of age
• • 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. Candidate for systemic therapy or phototherapy
• • 5. Women of childbearing potential must have a negative pregnancy test
• Exclusion Criteria:
• • 1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
• • 2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
• • 3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
• • 4. A known hypersensitivity to any components of the ORKA-001 drug product
• • 5. Women who are breastfeeding or plan to breastfeed during the study