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

A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants 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:

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. 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-002 drug product
5. Women who are breastfeeding or plan to breastfeed during the study