Phase III Study of ASP2151 in Herpes Simplex Patients

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Detailed Description
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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.

Official Title
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Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -

Conditions
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Herpes Simplex

Intervention / Treatment
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* Drug: ASP2151
* Drug: ASP2151 placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP2151<br> | Drug: ASP2151<br>* 200 mg once daily<br>|
| Placebo Comparator: ASP2151 placebo<br> | Drug: ASP2151 placebo<br>* once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects achieving lesion healing by Day 8 of study treatment |  | 8days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing |  | 29days | 
| Time to complete crusting |  | 29days | 
| Time to virus disappearance |  | 29days |