Phase 2/3 Multi-Center, Double-Blind, Controlled Trial Comparing Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir, and Combination Topical ARYS-01 Cream /Oral Valaciclovir for Treatment of Herpes Zoster in Immunocompetent Patients 18 Years of Age or Older
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- The effect of ARYS-01 (sorivudine) cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8.
研究概览
简要总结
A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.
详细描述
More than 95% of people are infected with varicella Zoster virus (VZV) at one time of life or another. Primary VZV infection manifests as varicella (chicken pox). The virus then establishes a latent infection of the sensory ganglia from which it may reactivate years later to produce the clinical syndrome of Herpes Zoster (shingles). The initial cutaneous VZV lesions are pruritic, erythematous macules; and the lesions progress through maculopapular stage to vesicular, ulceration and crusting phases. The crusting phase signals the beginning of the healing process, and begins with clouding of the vesicular fluid, within about 24 to 48 h after the appearance of each lesion. This is a Phase 2 study to assess: 1) the overall benefit of ARYS-01 (sorivudine) cream 3% vs. Placebo cream (with immediate or delayed use of Valaciclovir therapy) on Herpes Zoster rash healing rates and postherpetic neuralgia (PHN), 2) the efficacy of ARYS-01 cream 3% vs. Placebo cream, prior to initiation of Valaciclovir, to build evidence for monotherapy treatment benefit of ARYS-01 cream on the initial onset of Herpes Zoster symptoms, 3) the efficacy of ARYS-01 cream 3% vs. Placebo cream, with immediate or delayed initiation of Valaciclovir, for synergetic effects on the initial onset of Herpes Zoster symptoms.
The primary efficacy endpoint is the effect of ARYS-01 cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8. Secondary endpoints include time to cessation of new lesion formation, and time to cessation of Zoster-associated pains, pain intensity, rash healing and size reduction, and lesion dissemination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •diagnosed with herpes zoster
- •confirmed for VZV with lesion swab at screening and subsequent PCR test.
- •contraception for women of child-bearing potential
- •be able to communicate with investigator and compliant
排除标准
- •cytotoxic or immunosuppressive drugs within 3 mos, 5-FU or its pro-drugs, tricyclic antidepressants, probenecid, topical or systemic antiviral drugs or immunomodulatory agents for viral infection
- •herpes zoster ophthalmicus
- •female patients who are pregnant and/or nursing or planning a pregnancy
- •congenital, acquired or corticosteroid-induced immunodeficiency, including malignancy
- •renal insufficiency or creatinine level >2mg/dL
- •clinical significant liver enzyme abnormalities and any other laboratory abnormalities determined by the screening lab
- •history of intolerance or hypersensitivity to the cream components
- •current significant skin disease within affected dermatome
- •history of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV
- •current participation in another clinical drug research study
研究组 & 干预措施
3
Active cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
干预措施: valaciclovir (Drug)
1
Placebo cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
干预措施: placebo (Drug)
1
Placebo cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
干预措施: valaciclovir (Drug)
2
Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
干预措施: ARYS-01 (sorivudine) cream 3% or placebo cream (Drug)
2
Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
干预措施: placebo (Drug)
2
Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
干预措施: valaciclovir (Drug)
3
Active cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
干预措施: ARYS-01 (sorivudine) cream 3% or placebo cream (Drug)
3
Active cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
干预措施: placebo (Drug)
4
Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
干预措施: ARYS-01 (sorivudine) cream 3% or placebo cream (Drug)
4
Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
干预措施: valaciclovir (Drug)
结局指标
主要结局
The effect of ARYS-01 (sorivudine) cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8.
时间窗: Day 8
次要结局
- The time to cessation of new lesion formation, and time to cessation of Zoster-associated pains, pain intensity, rash healing and size reduction, and lesion dissemination.(Day 4)