Study to Compare Efficacy of Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir and Combination ARYS-01 Cream 3%/Oral Valaciclovir for Treatment of Herpes Zoster (Shingles)

aRigen Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Postherpetic Neuralgia; Herpes Zoster

Treatments: Drug: valaciclovir; Drug: placebo; Drug: ARYS-01 (sorivudine) cream 3% or placebo cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652184

ARYS-0701

Details and patient eligibility

About

A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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

Treatment:

Drug: valaciclovir

Drug: placebo

2

Active Comparator group

Description:

Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10

Treatment:

Drug: ARYS-01 (sorivudine) cream 3% or placebo cream

Drug: valaciclovir

Drug: placebo

3

Experimental group

Description:

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

Treatment:

Drug: ARYS-01 (sorivudine) cream 3% or placebo cream

Drug: valaciclovir

Drug: placebo

4

Other group

Description:

Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10

Treatment:

Drug: ARYS-01 (sorivudine) cream 3% or placebo cream

Drug: valaciclovir