A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (VVC)

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: SHR8008 capsule; Drug: Fluconazole capsule

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102200
      • Beijing Tsinghua Changgung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Females ≥18 and ≤75 years old;
2. Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining;
3. Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study;
4. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria:

1. Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;
2. Presence of concomitant vulvovaginitis caused by other pathogens;
3. History of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening;
4. Moderate to severe hepatic and/or renal disorders;
5. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;
6. Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization;
7. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
8. Presence of significant laboratory abnormalities at screening;
9. QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening;
10. Have planned surgeries or other medical procedures that may impact compliance with the protocol;
11. Known history of hypersensitivity or intolerance to azole antifungal drugs;
12. Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period;
13. History of narcotic or drug abuse or alcoholism within 6 months prior to screening;
14. Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening;
15. Other conditions unsuitable for participation in the study per investigator's judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group A; SHR8008 capsule	Drug: SHR8008 capsule; once daily for 2 days(Day 1 and Day 2),oral
ACTIVE_COMPARATOR: Treatment group B; Fluconazole capsule	Drug: Fluconazole capsule; once daily for 2 days(Every 72 hours) ,oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with therapeutic cure	defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects therapeutic cure		Day 14
The proportion of subjects with clinical cure	defined as absence of signs and symptoms of VVC	Day 14 and Day 28
The proportion of subjects with mycological cure	defined as negative culture of vaginal swabs for growth of Candida species	Day 14 and Day 28
Changes from baseline in VVC signs and symptoms score		Day 14 and Day 28
The proportion of subjects receiving rescue therapy during the study		28 days

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2021
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): September 30, 2021

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (ACTUAL): July 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: SHR8008-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No