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

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

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis

Study Overview

• Status: Recruiting
• Conditions: Recurrent Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: SHR8008; Drug: Fluconazole

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yong Cao, M.D; Phone Number: +0518-81220121; Email: yong.cao@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Jinghe Lang, Bachelor; Phone Number: +86-10-69156699; Email: langjh@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Females, ≥18 and ≤75 years old.
2. Have a history of RVVC at screening.
3. Suitable for oral therapy and able to swallow capsules intact.
4. Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
5. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria:

1. Presence of concomitant vulvovaginitis caused by other pathogens.
2. Have a 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 (not applicable to subjects with a history of total hysterectomy).
3. Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
4. Moderate to severe hepatic and/or renal disorders.
5. Significant laboratory abnormality at screening.
6. QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening.
7. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization.
8. Have received any estrogen replacement therapy or vaginal topical products.
9. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
10. Have planned surgery or other medical procedures that may impact compliance with the protocol;
11. Known history of hypersensitivity or intolerance to azole antifungal drugs.
12. History of narcotic or drug abuse or alcoholism, or any other medical, psychiatric or social condition that in the investigator's opinion could preclude compliance with the protocol.
13. Women who are pregnant or lactating, or planning to become pregnant during the study period.
14. Have received VT-1161 study medication in a previous study or received any investigational medicinal product (IMP) in a clinical study within 5 half-lives of that IMP prior to screening (if the half-life is unknown, 60 days prior to screening);
15. other conditions unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR8008	Drug: SHR8008; Dosing frequency: During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting from Week 3, Route of administration: oral
Active Comparator: Fluconazole	Drug: Fluconazole; Dosing frequency: During Part 1, administered orally 3 sequential doses (every 72 hours), During Part 2, administered orally once weekly for 6 Months starting from Week 3. Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with one or more culture-verified VVC episodes during the study.	50 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with resolved VVC episode (clinical signs and symptoms score of < 3) during induction phase	Day 14
The proportion of subjects with 2 culture-verified VVC episodes during the study.	week 50
The proportion of subjects with ≥ 3 culture-verified VVC episodes during the study.	week 50
The proportion of subjects with one or more culture-verified VVC episodes during the maintenance phase and follow-up phase.	Week 3 through Week 50
Time to first recurrence of a culture-verified VVC episode during the maintenance phase and follow-up phase.	Week 3 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase and follow-up phase	Week 3 through Week 50
The proportion of subjects receiving rescue treatment during the maintenance phase and follow-up phase.	Week 3 through Week 50
The proportion of subjects with clinical cure (defined as the absence of all signs and symptoms of VVC) at the end of induction phase .	Day 14
The proportion of subjects with mycological cure (defined as vaginal swab culture negative for growth of Candida species) at the end of induction phase.	Day 14
The proportion of subjects with therapeutic cure (clinical cure plus mycological cure) at the end of induction phase.	Day 14
The proportion of subjects with therapeutic cure, clinical cure, and mycological cure during the maintenance phase.	Day 14
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase	Week 3 through Week 13
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase	Week 3 through Week 13
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase	Week 3 through Week 26
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase	Week 3 through Week 26
The proportion of subjects with one or more culture-verified VVC episodes during the follow-up phase.	Week 27 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the follow-up phase	Week 27 through Week 50

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Recurrence; 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: SHR8008-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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