E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent Vulvovaginal Candidiasis |
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E.1.1.1 | Medical condition in easily understood language |
Recurrent yeast infection or vaginal thrush |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047784 |
E.1.2 | Term | Vulvovaginal candidiasis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of oral VT-1161 in the treatment of RVVC through Week 48 |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the safety and tolerability of oral VT-1161 in the treatment of RVVC through Week 48.
• To evaluate the impact of oral VT-1161 treatment on patient reported outcomes through Week 48. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Subjects must be generally healthy, non-pregnant females 12 years of age and older as of Screening. In Hungary and Czech Republic only, subjects must be generally healthy, non-pregnant females 18 years of age and older as of Screening.
2) Subjects must have a history of recurrent VVC as defined by three (3) or more episodes of acute VVC in the past 12 months, including the episode confirmed at Screening, with at least one episode (not including the current episode) documented by a positive culture, PCR, Affirm test, KOH test, Gram stain or a documented Pap test in the prior 12 months revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.
3) Subjects must have an acute VVC episode at Screening, defined as a total signs and symptoms score of ≥3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.
4) Subjects must have a composite vulvovaginal signs and symptoms score of <3 at the Baseline (Day 1) Visit.
5) Subjects must have a documented Pap test at Screening or within the current standard of care guidelines for the appropriate age requirement, reported as either “negative for intraepithelial lesion or malignancy” or “ASCUS-atypical squamous cells of undetermined significance” (not applicable to subjects with a history of total hysterectomy). |
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E.4 | Principal exclusion criteria |
1) Subjects must not have the presence of concomitant vulvovaginitis caused by other pathogens (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, or Neisseria gonorrhoeae) at Screening visit and at the Day 1 visit if an infection is suspected.
2) Subjects must not have an active HPV infection as evidenced by visible condylomas on vulvovaginal examination at Screening and Day 1 visits.
3) Subjects must not have the presence or a history of another vaginal or vulvar condition(s) that in the Investigator’s opinion would confound the interpretation of clinical response.
4) Subjects must not have a history of cervical cancer. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome measure is the proportion of subjects with one or more culture-verified acute VVC episodes during the Maintenance Phase (post-randomization through Week 48) in the ITT population. An acute VVC episode during the Maintenance Phase (considered a recurrent episode) is defined as a positive culture for Candida species and a clinical signs and symptoms score of ≥3. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
post-randomization through Week 48 |
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E.5.2 | Secondary end point(s) |
The key secondary efficacy outcome measures include the following:
a. Time to first recurrence of a culture-verified acute VVC episode with signs and symptoms score ≥3 during the Maintenance Phase.
b. The proportion of subjects with at least one positive culture for Candida during the Maintenance Phase.
c. The proportion of subjects with at least one culture-verified acute VVC episode with signs and symptoms of ≥3 post randomization through Week 24.
d. Change from Screening through Week 48 in the SF-36 mental component score (MCS).
e. Change from Screening through Week 48 in the SF-36 patient reported outcome survey total score. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
post-randomization through Week 48
post-randomization through Week 24 (c)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Czech Republic |
Hungary |
Romania |
Ukraine |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 26 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 26 |