Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of JTE-051 Administered for 12 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)

Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.

Inclusion Criteria:

• Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1
• Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;
• Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;
• Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;
• Body Mass Index (BMI) ≤40 at Visit 1.

Exclusion Criteria:

• Medical history of treatment failure to any systemic agents for plaque psoriasis;
• Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;
• Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1;
• History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;
• History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);