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Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

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: NCT03734991
Recruitment Status : Completed
First Posted : November 8, 2018
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: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Candida Vulvovaginitis
Interventions Drug: Ibrexafungerp
Drug: Placebo
Enrollment 376
Recruitment Details Participants were recruited based on physician referral at 28 medical centers between 04Jan2019 and 04Sep2019.
Pre-assignment Details  
Arm/Group Title Ibrexafungerp (SCY-078) Placebo
Hide Arm/Group Description

300 mg orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

Period Title: Overall Study
Started 249 127
Withdrawn Before Treatment 2 3
Withdrawn Before TOC 59 41
Completed the TOC Visit 188 83
Withdrawn At or After the TOC Visit 5 3
Completed 183 80
Not Completed 66 47
Reason Not Completed
Adverse Event             4             0
Lost to Follow-up             4             0
Physician Decision             0             1
Pregnancy             1             0
Withdrawal by Subject             6             3
Lack of efficacy and or/use of antifungal therapy             49             41
Other             2             2
Arm/Group Title Ibrexafungerp (SCY-078) Placebo Total
Hide Arm/Group Description

300 mg orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

Total of all reporting groups
Overall Number of Baseline Participants 247 124 371
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 124 participants 371 participants
<=18 years
0
   0.0%
1
   0.8%
1
   0.3%
Between 18 and 65 years
244
  98.8%
120
  96.8%
364
  98.1%
>=65 years
3
   1.2%
3
   2.4%
6
   1.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 247 participants 124 participants 371 participants
34.5  (11.22) 35.8  (12.47) 34.9  (11.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 124 participants 371 participants
Female
247
 100.0%
124
 100.0%
371
 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 247 participants 124 participants 371 participants
Hispanic or Latino
64
  25.9%
25
  20.2%
89
  24.0%
Not Hispanic or Latino
183
  74.1%
99
  79.8%
282
  76.0%
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 247 participants 124 participants 371 participants
American Indian or Alaska Native
2
   0.8%
0
   0.0%
2
   0.5%
Asian
4
   1.6%
0
   0.0%
4
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
101
  40.9%
51
  41.1%
152
  41.0%
White
132
  53.4%
71
  57.3%
203
  54.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   3.2%
2
   1.6%
10
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 247 participants 124 participants 371 participants
247 124 371
1.Primary Outcome
Title Clinical Cure (Complete Resolution of Signs and Symptoms)
Hide Description measured by 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 orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 188 98
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical cure
95
  50.5%
28
  28.6%
Clinical failure
93
  49.5%
70
  71.4%
2.Secondary Outcome
Title Mycological Eradication (Negative Culture for Growth of Yeast)
Hide Description 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 orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 188 98
Measure Type: Count of Participants
Unit of Measure: Participants
Mycological eradication
93
  49.5%
19
  19.4%
Mycological persistence
95
  50.5%
79
  80.6%
3.Secondary Outcome
Title Clinical Cure and Mycological Eradication (Responder Outcome)
Hide Description 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 orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 178 95
Measure Type: Count of Participants
Unit of Measure: Participants
Overall success
64
  36.0%
12
  12.6%
Overall failure
114
  64.0%
83
  87.4%
4.Secondary Outcome
Title Complete Clinical Response at Follow-Up
Hide Description 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 orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 190 100
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical cure at Follow up
113
  59.5%
44
  44.0%
Clinical failure at Follow up
77
  40.5%
56
  56.0%
5.Secondary Outcome
Title Overall Treatment-Emergent Adverse Events (Safety Set)
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 orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 247 124
Measure Type: Count of Participants
Unit of Measure: Participants
Any treatment-emergent, treatment-related adverse event
98
  39.7%
21
  16.9%
No treatment-emergent, treatment-related adverse events
149
  60.3%
103
  83.1%
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 orally every 12 hrs for 1 day (2 doses in 1 day)

Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day

Matching Placebo

Placebo: Matching placebo

All-Cause Mortality
Ibrexafungerp (SCY-078) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/247 (0.00%)   0/124 (0.00%) 
Hide Serious Adverse Events
Ibrexafungerp (SCY-078) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/247 (0.40%)   2/124 (1.61%) 
Investigations     
Hypokalaemia   0/247 (0.00%)  1/124 (0.81%) 
Metabolism and nutrition disorders     
Diabetes mellitus   0/247 (0.00%)  1/124 (0.81%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia and bronchial hyperreactivity   1/247 (0.40%)  0/124 (0.00%) 
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   117/247 (47.37%)   34/124 (27.42%) 
Gastrointestinal disorders     
Diarrhoea   63/247 (25.51%)  8/124 (6.45%) 
Nausea   40/247 (16.19%)  7/124 (5.65%) 
Abdominal pain   17/247 (6.88%)  3/124 (2.42%) 
Abdominal discomfort   14/247 (5.67%)  2/124 (1.61%) 
Infections and infestations     
Bacterial vaginosis   13/247 (5.26%)  10/124 (8.06%) 
Nervous system disorders     
Headache   23/247 (9.31%)  11/124 (8.87%) 
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: NCT03734991    
Other Study ID Numbers: SCY-078-303
First Submitted: October 30, 2018
First Posted: November 8, 2018
Results First Submitted: June 30, 2021
Results First Posted: September 8, 2021
Last Update Posted: September 8, 2021