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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987620
Recruitment Status : Completed
First Posted : June 17, 2019
Results First Posted : September 8, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Candida Vulvovaginitis
Interventions Drug: Ibrexafungerp
Drug: Placebo
Enrollment 455
Recruitment Details Participants were recruited based on physician referral at 22 medical center between 07Jun2019 and 07Feb2020.
Pre-assignment Details  
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

Period Title: Overall Study
Started 303 152
Withdrawn Before Treatment 5 1
Withdrawn Before TOC 48 45
Completed the TOC Visit 250 106
Withdrawn At or After the TOC Visit 4 4
Completed 246 102
Not Completed 57 50
Reason Not Completed
Lack of Efficacy or Use of antifungal therapy             43             41
Adverse Event             3             0
Lost to Follow-up             1             2
Physician Decision             0             1
Pregnancy             1             0
Withdrawal by Subject             7             1
Other             2             5
Arm/Group Title Ibrexafungerp (SCY-078) Placebo Total
Hide Arm/Group Description

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

Total of all reporting groups
Overall Number of Baseline Participants 298 151 449
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 151 participants 449 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
296
  99.3%
149
  98.7%
445
  99.1%
>=65 years
2
   0.7%
2
   1.3%
4
   0.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 298 participants 151 participants 449 participants
34.1  (10.45) 34.5  (10.94) 34.2  (10.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 151 participants 449 participants
Female
298
 100.0%
151
 100.0%
449
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 151 participants 449 participants
Hispanic or Latino
36
  12.1%
14
   9.3%
50
  11.1%
Not Hispanic or Latino
262
  87.9%
137
  90.7%
399
  88.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 151 participants 449 participants
American Indian or Alaska Native
1
   0.3%
1
   0.7%
2
   0.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
51
  17.1%
27
  17.9%
78
  17.4%
White
246
  82.6%
123
  81.5%
369
  82.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 298 participants 151 participants 449 participants
United States 105 66 171
Bulgaria 193 85 278
1.Primary Outcome
Title Clinical Cure (Complete Resolution of Signs and Symptoms)
Hide Description The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Time Frame Day 8-14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description:

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

Overall Number of Participants Analyzed 188 84
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical cure
119
  63.3%
37
  44.0%
Clinical failure
69
  36.7%
47
  56.0%
2.Secondary Outcome
Title Mycological Eradication (Negative Culture for Growth of Yeast)
Hide Description The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Time Frame Day 8-14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description:

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

Overall Number of Participants Analyzed 188 84
Measure Type: Count of Participants
Unit of Measure: Participants
Mycological eradication
110
  58.5%
25
  29.8%
Mycological persistence
78
  41.5%
59
  70.2%
3.Secondary Outcome
Title Clinical Cure and Mycological Eradication (Responder Outcome)
Hide Description The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Time Frame Day 8-14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description:

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

Overall Number of Participants Analyzed 178 81
Measure Type: Count of Participants
Unit of Measure: Participants
Overall success
82
  46.1%
23
  28.4%
Overall failure
96
  53.9%
58
  71.6%
4.Secondary Outcome
Title Complete Clinical Response at Follow-up
Hide Description The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Time Frame Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description:

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

Overall Number of Participants Analyzed 189 89
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical cure at Follow up
137
  72.5%
44
  49.4%
Clinical failure at Follow up
52
  27.5%
45
  50.6%
5.Secondary Outcome
Title Safety and Tolerability of Ibrexafungerp
Hide Description Number of subjects with treatment related adverse events
Time Frame Up to 29 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description:

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

Overall Number of Participants Analyzed 100 45
Measure Type: Count of Participants
Unit of Measure: Participants
Any treatment-emergent adverse event
99
  99.0%
44
  97.8%
Any serious treatment-emergent adverse event
1
   1.0%
1
   2.2%
Any treatment-related treatment-emergent serious adverse event
0
   0.0%
0
   0.0%
Any treatment-emergent adverse event leading to treatment discontinuation
0
   0.0%
0
   0.0%
Any adverse event leading to death
0
   0.0%
0
   0.0%
Time Frame 4 weeks after last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description

300 mg BID for one day

Ibrexafungerp: Ibrexafungerp 300mg BID for one day

Matching Placebo

Placebo: Matching Placebo

All-Cause Mortality
Ibrexafungerp (SCY-078) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/298 (0.00%)   0/151 (0.00%) 
Hide Serious Adverse Events
Ibrexafungerp (SCY-078) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/298 (0.34%)   1/151 (0.66%) 
Gastrointestinal disorders     
Gastrointestinal bacterial infection   1/298 (0.34%)  0/151 (0.00%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis   0/298 (0.00%)  1/151 (0.66%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibrexafungerp (SCY-078) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   63/298 (21.14%)   15/151 (9.93%) 
Gastrointestinal disorders     
Diarrhoea   28/298 (9.40%)  1/151 (0.66%) 
Nausea   25/298 (8.39%)  4/151 (2.65%) 
Nervous system disorders     
Headache   22/298 (7.38%)  11/151 (7.28%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Angulo
Organization: SCYNEXIS
Phone: (201) 884-5471
EMail: david.angulo@scynexis.com
Layout table for additonal information
Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03987620    
Other Study ID Numbers: SCY-078-306
First Submitted: June 12, 2019
First Posted: June 17, 2019
Results First Submitted: June 30, 2021
Results First Posted: September 8, 2021
Last Update Posted: September 8, 2021