Phase III Study of ASP2151 in Herpes Zoster Patients

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.

Detailed Description
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A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment to demonstrate the non-inferiority of ASP2151 to VACV. 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 Zoster Patients- A Double-blind, Valaciclovir-controlled Study

Conditions
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Herpes Zoster

Intervention / Treatment
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* Drug: ASP2151
* Drug: valaciclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash 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 < 50 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(200 mg)<br>once daily | Drug: ASP2151<br>* 200 mg once daily or 400 mg once daily<br>|
| Experimental: ASP2151(400mg)<br>once daily | Drug: ASP2151<br>* 200 mg once daily or 400 mg once daily<br>|
| Experimental: valaciclovir<br>1000 mg three times daily | Drug: valaciclovir<br>* 1000 mg three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The new lesion formation was defined as the state in which the number of rashes is increasing. | 4days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cessation of New Lesion Formation | The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The new lesion formation was defined as the state in which the number of rashes is increasing. | 29days | 
| Time to Complete Crusting | We defined the following state as Complete crusting. A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and all rashes are crusted (epithelialization of the base of crusts is not required). In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared. | 29days | 
| Time to Healing | We defined the following state as Healing. A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and complete disappearance of crusts or complete epithelialization of the base of crusts are considered to have been achieved. In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared | 29days | 
| Time to Pain Resolution | Investigators assessed the pain using NRS. The date of pain resolution is defined as the first day when all NRS scores are rated as 2 or less, and such scores are continuously observed until Day 92 or discontinuation visit. | 29days | 
| Time to Virus Disappearance | Virus desiappearance was defined as the participants who who reached virus-negative status according to the virus isolation and culture assay or whose samples were not available because of complete crusting or healing | 29days |