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

NCT05074602 | Unknown Phase 3

• 1 other identifier: SHR8008-301
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with one or more culture-verified VVC episodes during the study.

  50 weeks

Secondary Outcomes (17)

• 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

Study Arms (2)

SHR8008

EXPERIMENTAL

Drug: SHR8008

Fluconazole

ACTIVE COMPARATOR

Drug: Fluconazole

Interventions

SHR8008 DRUG

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

SHR8008

Fluconazole DRUG

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

Fluconazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yong Cao, M.D

CONTACT

+0518-81220121; yong.cao@hengrui.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

Model Details: A Randomized, Double-Blind, active controlled, parallel groups, Multicenter Phase III Clinical Study

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: September 14, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 12, 2021

Record last verified: 2021-09

Locations

CN (1)