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

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

Official Title
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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)

Conditions
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Recurrent Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: SHR8008
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females, ≥18 and ≤75 years old. Have a history of RVVC at screening. Suitable for oral therapy and able to swallow capsules intact. Subjects of childbearing potential must use highly effective contraceptive measures throughout the study. Willing to sign the informed consent form to participate in this study. Exclusion Criteria: Presence of concomitant vulvovaginitis caused by other pathogens. 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). Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination. Moderate to severe hepatic and/or renal disorders. Significant laboratory abnormality at screening. QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization. Have received any estrogen replacement therapy or vaginal topical products. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization; Have planned surgery or other medical procedures that may impact compliance with the protocol; Known history of hypersensitivity or intolerance to azole antifungal drugs. 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. Women who are pregnant or lactating, or planning to become pregnant during the study period. 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); other conditions unsuitable for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Double-Blind, active controlled, parallel groups, Multicenter Phase III Clinical Study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR8008<br> | Drug: SHR8008<br>* 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<br>|
| Active Comparator: Fluconazole<br> | Drug: Fluconazole<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |