Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer

NCT05806918 | Unknown Phase 3

• 1 other identifier: ZK-A03-LEES-2023-01
• Study Type: interventional
• Target: 368
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster. This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Eligible patients will be assigned randomly at a 1:1 ratio. For each patient who is included, treatment may last up to 10 days. During the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate at visit 4 (Day 7)

  Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.

  7 Days

Secondary Outcomes (5)

• Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11)

  11 Days

• Time to which new blisters stop appearing

  11 Days

• The time to beginning of crusting.

  11 Days

• The time to which all blisters are crustosus.

  11 Days

• The pain improvement rate at visit 4 (Day 7)

  7 Days

Study Arms (2)

Recombinant Human Interferon α-2b Gel (After the Alteration)

EXPERIMENTAL

Drug: Recombinant Human Interferon α-2b Gel (After the Alteration)

Recombinant Human Interferon α-2b Gel (Before the Alteration)

ACTIVE COMPARATOR

Drug: Recombinant Human Interferon α-2b Gel (Before the Alteration)

Interventions

Recombinant Human Interferon α-2b Gel (After the Alteration) DRUG

Recombinant human interferon α-2b gel (after the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.

Recombinant Human Interferon α-2b Gel (After the Alteration)

Recombinant Human Interferon α-2b Gel (Before the Alteration) DRUG

Recombinant human interferon α-2b gel (before the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.

Recombinant Human Interferon α-2b Gel (Before the Alteration)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 18 and 70 years old.
• Diagnosed as herpes zoster.
• Time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (BSA).
• Self-rated Numerical Rating Scale (NRS) in pain ≤ 6.
• Negative serum pregnancy test for women of reproductive age. Birth control from first dosing until 1 month after last dosing for all men and women of reproductive age.
• Subjects must have signed an informed consent form (ICF).

You may not qualify if:

• Diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis.
• The lesion is complicated with other skin diseases that may affect the evaluation of efficacy,
• Skin lesions combined with severe bacterial or fungal infections.
• Use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing.
• Known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy.
• Liver and/or renal disfunction，ie. Alanine aminotransferase (ALT), Aspartate transaminase (AST) \> 2 times of upper normal limit（ULN）; Creatinine Clearance Rate (CCR) \< 50 L/min.
• Combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs.
• Combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment.
• History of psychiatric illness or inability to fully comply to the protocol.
• Use of another investigational product within 4 weeks prior to the first dosing.
• Pregnant or lactating women.
• Other conditions deemed by the investigator to be inappropriate for participation in this trial.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Jinghua Xu, MD

CONTACT

021-52887781; xjhhsyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 10, 2023
• Study Start: April 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share