Phase III Study of ASP2151 in Herpes Zoster Patients

Phase III Study of ASP2151 in Herpes Zoster Patients- A Double-blind, Valaciclovir-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Drug: ASP2151; Drug: valaciclovir

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 751
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan
  • Tokyo
    • Nakano-Ku, Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Patients who are not expected to have an adequate response to oral antiviral medication
2. An extreme decline in immune function
3. Presence of serious complications

4. 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
5. Current or previous history of malignant tumor within 5 years before informed consent
6. Diagnosis of autoimmune disease
7. Evidence of bone marrow suppression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP2151(200 mg); once daily	Drug: ASP2151; 200 mg once daily or 400 mg once daily
Experimental: ASP2151(400mg); once daily	Drug: ASP2151; 200 mg once daily or 400 mg once daily
Experimental: valaciclovir; 1000 mg three times daily	Drug: valaciclovir; 1000 mg three times daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.
• Investigators: Study Director: Maruho Co.,Ltd. Kyoto R&D Center, Clinical Development Department

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 10, 2015

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex; Anti-Infective Agents; Antiviral Agents; Valacyclovir
• Other Study ID Numbers: M522101-J01