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Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (Vanish 306)

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ClinicalTrials.gov Identifier: NCT03987620
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Scynexis, Inc.

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

Condition or disease Intervention/treatment Phase
Candida Vulvovaginitis Drug: Ibrexafungerp Drug: Placebo Phase 3

Detailed Description:

Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:

  • Oral ibrexafungerp 300-mg dose BID (bis in die) for 1 day
  • Oral ibrexafungerp matching placebo BID for 1 day

This is a randomized, double-blind study.

Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, double-blind study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibrexafungerp (SCY-078)
300 mg BID for one day
Drug: Ibrexafungerp
Ibrexafungerp 300mg BID for one day
Other Name: SCY-078

Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching Placebo




Primary Outcome Measures :
  1. Clinical cure (complete resolution of signs and symptoms) [ Time Frame: Day 8-14 ]
    The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit


Secondary Outcome Measures :
  1. Mycological eradication (negative culture for growth of yeast) [ Time Frame: Day 8-14 ]
    The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit

  2. Clinical cure and mycological eradication (responder outcome) [ Time Frame: Day 8-14 ]
    The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit

  3. Complete resolution of signs and symptoms at follow-up [ Time Frame: Day 25 ]
    The percentage of subjects with complete resolution of symptoms at the Follow-up (FU) visit

  4. Safety and tolerability of Ibrexafungerp [ Time Frame: Up to 29 Days ]
    Number of subjects with 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

Inclusion Criteria:

  • Subject is a postmenarchal female subject 12 years and older
  • Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Exclusion Criteria:

  • Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
  • Need for systemic and/or topical (vaginal) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
  • Subject has uncontrolled diabetes mellitus.
  • Subject has a vaginal sample with pH >4.5.
  • Subject has a history of or an active cervical/vaginal cancer.

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): NCT03987620


Contacts
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Contact: Philip O Deane, M.Sc 201 688 2241 philip.deane@scynexis.com
Contact: David Angulo, MD 786 942 3854 david.angulo@scynexis.com

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Locations
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United States, Arizona
Mesa OB-GYN Recruiting
Mesa, Arizona, United States, 85209
Contact: Ernesto M Gomez, MD    602-370-4691      
United States, Colorado
Red Rocks OBGYN Recruiting
Lakewood, Colorado, United States, 80228
Contact: Kelle Oberle    303-985-9100    kso@redrocksobgyn.com   
United States, Connecticut
Planned Parenthood Southern New England Recruiting
New Haven, Connecticut, United States, 06511
Contact: Clair Kaplan, MD    203-752-2864      
United States, Florida
New Generation Medical Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Karelia Ruiz, MD    305-828-9100    kareliar@ngmresearch.com   
Healthcare Clinical Data Inc Recruiting
North Miami, Florida, United States, 33161
Contact: Stephen Chavoustie, MD    305-722-8444      
Physician Care Clinical Research LLC Recruiting
Sarasota, Florida, United States, 34239
Contact: Gregory Swor, MD    941-954-2355    MSwor@PCCRSarasota.com   
CCT LLC - A VitaLink Company- PPDS Recruiting
West Palm Beach, Florida, United States, 33409
Contact: Ronald Ackerman, MD    561-478-3177      
United States, Georgia
Mount Vernon Clinical Research, LLC Recruiting
Sandy Springs, Georgia, United States, 30328
Contact: Stephen Blank, MD    404-843-4410      
Fellows Research Alliance Inc Recruiting
Savannah, Georgia, United States, 31406
Contact: Debra Walland, MD    912-355-4447      
United States, Idaho
Rosemark Women Care Specialists Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Jason Gundersen, MD    208-557-2900      
United States, Louisiana
Praetorian Pharmaceutical Research, LLC Recruiting
Marrero, Louisiana, United States, 70072
Contact: Clifton Nicholson-Uhl, MD    504-328-2601      
United States, Missouri
North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri Recruiting
Florissant, Missouri, United States, 63033
Contact: Colleen McNicholas, MD    314-531-7526      
United States, Nevada
Clinical Research Center Of Nevada Recruiting
Las Vegas, Nevada, United States, 89123
Contact: Timothy Sauter, MD    702-893-8968    tsauter@crcnnv.com   
United States, New Jersey
Planned Parenthood North Central Southern New Jersey (PPNCSNJ) Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Gregory Hirsch, MD    908-581-7770    gregory.hirsch@ppgnnj.org   
United States, North Carolina
Carolina Institute for Clinical Research - M3 Wake Research Recruiting
Fayetteville, North Carolina, United States, 28304
Contact: Connette McMahon, MD    910-302-8151    cmcmahon@tarheelclinical.com   
United States, Pennsylvania
Obstetrics and Gynecology Associates of Erie, PC Recruiting
Erie, Pennsylvania, United States, 16507
Contact: Michael Scutella, MD    814-459-1851      
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Joel Lebed, MD    215-351-5507    joel.lebed@ppsp.org   
United States, South Carolina
Fellows Research Alliance Inc Recruiting
Bluffton, South Carolina, United States, 29910
Contact: Patricia Thompson, MD    843-837-5590      
United States, Tennessee
Chattanooga Medical Research Inc Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Kirk Brody, MD    423-648-7794      
United States, Texas
Signature GYN Services, PLLC Recruiting
Fort Worth, Texas, United States, 76104
Contact: John Whitfield, MD    817-927-2229    johnwhitfield@johnwhitfieldmd.com   
Brownstone Clinical Trials, LLC Recruiting
Irving, Texas, United States, 75062
Contact: Jeff Livingstone, MD    972-256-3700    jlivingston@bctrials.com   
Bulgaria
Multiprofile Hospital for Active Treatment -Asenovgrad EOOD Recruiting
Asenovgrad, Bulgaria, 4230
Contact: Bogdan Chervenkov, MD    +35 988 853 7960      
MHAT Puls AD - PPDS Recruiting
Blagoevgrad, Bulgaria, 2700
Contact: Antoaneta Barakova, MD    +35 989 546 9364      
Multiprofile Hospital for Active Treatment - Chirpan EOOD Recruiting
Chirpan, Bulgaria, 6200
Contact: Nedelcho Totev, MD    +359887567805      
Medical Center Asklepii OOD Recruiting
Dupnitsa, Bulgaria, 2600
Contact: Dimka Delcheva-Zantina, MD    +35 989 571 1665      
Diagnostic-Consultative Center I-Gabrovo EOOD Recruiting
Gabrovo, Bulgaria, 5300
Contact: Mariana Milcheva, MD    +35 988 864 4676      
Multiprofile Hospital For Active Treatment Dr Tota Venkova Recruiting
Gabrovo, Bulgaria, 5300
Contact: Ilian Mitev, MD    +35 988 742 9284      
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD Recruiting
Gorna Oryahovitsa, Bulgaria, 5100
Contact: Mihail Milotovich, MD    +35 888 889 8877    milatovichmbalgo@gmail.com   
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD Recruiting
Lom, Bulgaria, 3600
Contact: Eduard Bogomilov, MD    +35 99 716 0065      
Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD Recruiting
Lovech, Bulgaria, 5500
Contact: Ivo Petrakiev, MD    +359898453207      
MHAT Stamen Iliev AD Recruiting
Montana, Bulgaria, 3400
Contact: Tanya Dzhonova, MD    +35 988 265 5182      
Multiprofile Hospital For Active Treatment - Pazardzhik AD Recruiting
Pazardzhik, Bulgaria, 4400
Contact: Iliyan Trayanov, MD    +35 989 823 3776    trayanovv@abv.bg   
Multiprofile Hospital for Active Treatment Trimontsium OOD Recruiting
Plovdiv, Bulgaria, 4000
Contact: Svetoslav Illiev, MD    +35 929 759 0420      
Multiprofile Hospital for Active Treatment - Samokov EOOD Recruiting
Samokov, Bulgaria, 2000
Contact: Antoaneta Kancheva-Nikolcheva, MD    +35 988 892 9917    t_kuncheva@abv.bg   
Medical Center-1-Sevlievo EOOD Recruiting
Sevlievo, Bulgaria, 5400
Contact: Nikolay Vichev, MD         
Multiprofile Hospital for Active Treatment Shumen Recruiting
Shumen, Bulgaria, 9700
Contact: Ivaylo Balabanov, MD    +35 988 216 3044      
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD Recruiting
Smolyan, Bulgaria, 4700
Contact: Dimitar Delchev, MD    +35 988 977 8485      
Medical Center Excelsior OOD - PPDS Recruiting
Sofia, Bulgaria, 1407
Contact: Roumen Velev, MD    +35 988 845 1637    velev.dr@abv.bg   
Diagnostic Consultative CTR - XX - Sofia - EOOD Recruiting
Sofia, Bulgaria, 1618
Contact: Anna Dimova, MD    +35 988 865 1394    anna.di@abv.bg   
Medical center Vip Clinic OOD Recruiting
Sofia, Bulgaria, 1680
Contact: Aneta Kosturska    +35 988 893 6774      
Medical Center Medica Plus OOD Recruiting
Veliko Tarnovo, Bulgaria, 5000
Contact: Aneta Manoilova-Grigorova, MD    +35 988 871 1050      
Sponsors and Collaborators
Scynexis, Inc.
PPD

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Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03987620     History of Changes
Other Study ID Numbers: SCY-078-306
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 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.:
Vaginitis
Yeast infection
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Vulvovaginitis
Mycoses
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases