Phase III Study of ASP2151 in Herpes Simplex Patients

Phase 3

Completed

• Conditions: Herpes Simplex
• Interventions: Drug: ASP2151 placebo; Drug: ASP2151

• Registration Number: NCT01959295
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Detailed Description

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Primary Completion: 2015-04
• Study Completion: 2015-04-27
• Results First Submitted: 2024-02-18
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Results First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

1. 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

2. Patients who can start receiving the study drug within 48 hours after onset of rash

3. Age: 20 years or older, but younger than 80 years

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 < 30 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP2151 placebo	ASP2151 placebo	-
ASP2151	ASP2151	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Healing by Day 8	8days	The percentage of participants achieving lesion healing by Day 8 of study treatment

Secondary Outcome Measures

Name	Time	Method
Time to Healing	29days	The criteria for determining healing are as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved.; 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.; 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions
Time to Complete Crusting	29days	The criteria for complete crust formation are outlined as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required).; 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.; 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.
Time to Virus Disappearance	29days	The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site.