Phase III Study of ASP2151 in Herpes Simplex Patients

A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Inclusion criteria

• Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated

• Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
• Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
• Patients who can start receiving the study drug within 48 hours after onset of rash
• Age: 20 years or older, but younger than 80 years

Exclusion criteria

• Patients who are not expected to have an adequate response to oral antiviral medication
• An extreme decline in immune function
• Presence of serious complications
• Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

• AST or ALT ≥ 2.5 x upper limit of normal
• Platelet count < lower limit of normal
• Serum creatinine ≥ 1.5 mg/dL
• Creatinine clearance < 30 mL/min
• Current or previous history of malignant tumor within 5 years before informed consent
• Diagnosis of autoimmune disease
• Evidence of bone marrow suppression