Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.

The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo.

The study will consist of 3 periods:

• Screening Period
• Induction Period
• Post-treatment Follow-up Period

Inclusion criteria

• Participants ≥ 18 and < 80 years of age at the time of consent
• Have a diagnosis of plaque psoriasis for > 6 months
• Have moderate-to-severe chronic plaque psoriasis defined as:

• BSA ≥ 10%, and
• PASI ≥ 12, and
• IGA score of ≥ 3 on a 5-point scale
• Candidate for systemic therapy or phototherapy
• Women of childbearing potential must have a negative pregnancy test

Exclusion criteria

• Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis)
• 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
• History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
• A known hypersensitivity to any components of the ORKA-002 drug product
• Women who are breastfeeding or plan to breastfeed during the study