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Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) (CANDLE)

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ClinicalTrials.gov Identifier: NCT04029116
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Brief Summary:
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

Condition or disease Intervention/treatment Phase
Recurrent Vulvovaginal Candidiasis Drug: Fluconazole Tablet Drug: IBREXAFUNGERP Drug: Placebo oral tablet Phase 3

Detailed Description:

This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.

Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label (acute phase treatment) followed by Randomized, Double Blinded phase
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: Ibrexafungerp
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Drug: Fluconazole Tablet
150 mg every 72 hours for 3 doses

Drug: IBREXAFUNGERP
300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Other Name: SCY-078

Placebo Comparator: Placebo
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
Drug: Fluconazole Tablet
150 mg every 72 hours for 3 doses

Drug: Placebo oral tablet
BID (one day) every 4 weeks for a total of 6 dosing days




Primary Outcome Measures :
  1. Clinical Success [ Time Frame: Week 24 ]
    Efficacy as measured by the percentage of subjects with documented Clinical Success.


Secondary Outcome Measures :
  1. The percentage of subjects with no Mycologically Proven Recurrence [ Time Frame: Week 24 and Week 36 ]
    Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence

  2. Safety and tolerability [ Time Frame: Week 24 ]
    Safety as measured by the number of subjects who discontinue due to treatment related adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
  • History of 3 or more episodes of VVC in the past 12 months.
  • Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
  • Able to take oral tablets and capsules.

Key exclusion Criteria:

  • Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
  • Recent use of systemic and/or topical vaginal antifungal products.
  • Pregnant.
  • History of major system organ disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029116


Contacts
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Contact: Philip Deane 201 688 2241 ext 2241 philip.deane@scynexis.com
Contact: Nkechi Azie, MD Nkechi.azie@scynexis.com

Locations
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United States, Arizona
Precision Trials LLC Recruiting
Phoenix, Arizona, United States, 85032
Contact: Valerie Sorkin-Wells, MD         
United States, Florida
Healthcare Clinical Data Inc Recruiting
North Miami, Florida, United States, 33161
Contact: Steven Chavoustie, MD         
United States, Louisiana
Women Under Study, LLC Recruiting
New Orleans, Louisiana, United States, 70125
Contact: Jane Miller, MD         
United States, New Jersey
Center For Women's Health and Wellness LLC Recruiting
Lawrenceville, New Jersey, United States, 08648
Contact: Scott Eder, MD         
United States, New Mexico
Bosque Women's Care Not yet recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Carrie Swartz, MD         
United States, North Carolina
M3 Wake Research, Inc Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Pouruchis Bhiwandiwalla, MD         
United States, Tennessee
Chattanooga Medical Research Inc Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Kirk Brody, MD         
Medical Research Center of Memphis, LLC Recruiting
Memphis, Tennessee, United States, 38120
Contact: B Chappell, MD         
United States, Texas
TMC Life Research Inc Recruiting
Houston, Texas, United States, 77054
Contact: Mark Jacobs, MD         
Sponsors and Collaborators
Scynexis, Inc.
Investigators
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Study Director: Nkechi Azie, MD Scynexis, Inc.

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Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT04029116     History of Changes
Other Study ID Numbers: SCY-078-304
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scynexis, Inc.:
Recurrent yeast infection
Recurrent yeast vaginitis
Chronic yeast vaginitis
Ibrexafungerp
SCY-078
RVVC
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors