A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients

Official title

A Multicenter, Randomized, Double-blind, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of WXSH0102 Tablets in the Treatment of Vulvovaginal Candidiasis (VVC)

Overview

This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.

Interventions

• Drug WXSH0102/placebo
  Administer WXSH0102 tablets/placebo orally.
• Drug fluconazole capsules/placebo
  Administer fluconazole capsules/placebo orally

Primary outcome measures

• Proportion of subjects achieving cure at the D11±2 visit. [Time frame: day 11±2]

Secondary outcome measures (12)

• Proportion of subjects achieving clinical cure at the D11±2 visit [Time frame: day 11±2]
• Proportion of subjects achieving mycological clearance at the D11±2 visit [Time frame: day 11±2]
• Proportion of subjects achieving clinical improvement at the D11±2 visit [Time frame: day 11±2]
• Difference in VVC scale scores between the D11±2 visit and baseline visit [Time frame: day 11±2]
• Proportion of subjects achieving cure at the D25±3 visit. [Time frame: Day 25±3]
• Proportion of subjects achieving mycological clearance at the D25±3 visit [Time frame: Day 25±3]
• Proportion of subjects achieving clinical improvement at the D25±3 visit [Time frame: Day 25±3]
• Proportion of subjects requiring rescue therapy during the trial; [Time frame: Day 25±3]
• Proportion of subjects with normal vaginal microecology assessments [Time frame: Day11±2 and day 25±3]
• adverse events [Time frame: Day 25±3]
• AUC0-tau [Time frame: day 4]
• Cmax [Time frame: day 4]

Eligibility criteria

Inclusion criteria

• The subjects understood and voluntarily signed the informed consent Form (ICF), and were willing and able to comply with the study protocol.
• Female participants who signed ICF at the age of 18-64 years (including the cut-off value) and had sexual intercourse;
• Participants were diagnosed with VVC and met each of the following criteria: a. At screening, the total score on the VVC scale was ≥4 and at least two of the symptoms or signs on the VVC scale were present; b. A vaginal discharge sample collected at screening was Gram stain positive for Candida (hypha/pseudohypha/budding); c. Vaginal pH ≤4.5; Symptoms: vulvovaginal itching, vulvar burning pain, dyspareunia and urination pain, excessive secretion, secretion is tofu residue like; Physical signs: gynecological examination showed vulvar hyperemia and edema, which may be accompanied by scratches. In severe cases, chapped skin, exfoliation and even erosion could be seen. Vaginal mucosa was hyperemic, vaginal secretion was curd or tofu residue like;
• Subjects who are capable of oral administration;
• For the duration of the study, participants agreed to abstain from sexual activity and to use the condom throughout sexual activity.

Exclusion criteria

• Known or suspected allergic history to any component of this product, fluconazole or pyrrole drugs;
• Subjects with any vulvovaginal or cervical disease that may affect the diagnosis and evaluation of VVC;
• Topical or systemic antifungal treatment for VVC within 14 days before randomization;
• Significant liver disease or abnormal liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] > 1.5 ULN); Patients with severe renal disease or renal insufficiency (glomerular filtration rate (GFR) < 60ml/min/1.73m2 );
• Patients who planned to undergo treatment or surgery for vulvar, vaginal or cervical lesions during the study period;
• Severe gastrointestinal disease or other conditions that may affect the absorption of the trial drug;
• Patients with severe heart, lung, liver, kidney dysfunction and hematopoietic system diseases;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• 251 Yaojiayuan Road, Chaoyang District, Beijing — Beijing
• Beijing Obstetrics and Gynecology Hospital — Beijing

Identifiers

NCT: NCT06771063 · WXSH0102-02-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗