Trial Outcomes & Findings for A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis (NCT NCT02147899)
NCT ID: NCT02147899
Last Updated: 2020-11-13
Results Overview
Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
215 participants
Primary outcome timeframe
Study Days 21-30
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
SYM-1219 Low Dose
Administered orally
SYM-1219
|
SYM-1219 High Dose
Administered orally
SYM-1219
|
Placebo
Administered orally
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
72
|
72
|
|
Overall Study
COMPLETED
|
71
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
Baseline characteristics by cohort
| Measure |
SYM-1219 Low Dose
n=71 Participants
Administered orally
SYM-1219
|
SYM-1219 High Dose
n=72 Participants
Administered orally
SYM-1219
|
Placebo
n=72 Participants
Administered orally
Placebo
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
71 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Study Days 21-30Population: mITT
Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)
Outcome measures
| Measure |
SYM-1219 Low Dose
n=64 Participants
Administered orally
SYM-1219
|
SYM-1219 High Dose
n=62 Participants
Administered orally
SYM-1219
|
Placebo
n=62 Participants
Administered orally
Placebo
|
|---|---|---|---|
|
Cure of Bacterial Vaginosis
Clinical Outcome Responder
|
33 Participants
|
42 Participants
|
11 Participants
|
|
Cure of Bacterial Vaginosis
Non-Responder
|
31 Participants
|
20 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Study Days 21-30Population: Safety Population
Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)
Outcome measures
| Measure |
SYM-1219 Low Dose
n=64 Participants
Administered orally
SYM-1219
|
SYM-1219 High Dose
n=62 Participants
Administered orally
SYM-1219
|
Placebo
n=62 Participants
Administered orally
Placebo
|
|---|---|---|---|
|
Cure of Bacterial Vaginosis
|
64 Participants
|
62 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Study Days 21-30Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.
Outcome measures
| Measure |
SYM-1219 Low Dose
n=64 Participants
Administered orally
SYM-1219
|
SYM-1219 High Dose
n=62 Participants
Administered orally
SYM-1219
|
Placebo
n=62 Participants
Administered orally
Placebo
|
|---|---|---|---|
|
Number of Patients With Therapeutic Cure
|
14 Participants
|
25 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Study Days 21-30Population: mITT
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Outcome measures
| Measure |
SYM-1219 Low Dose
n=64 Participants
Administered orally
SYM-1219
|
SYM-1219 High Dose
n=62 Participants
Administered orally
SYM-1219
|
Placebo
n=62 Participants
Administered orally
Placebo
|
|---|---|---|---|
|
Number of Patients With a Normal Nugent Score
Nugent Score 0-3 (Normal)
|
15 Participants
|
25 Participants
|
4 Participants
|
|
Number of Patients With a Normal Nugent Score
Nugent Score ≥4 (Abnormal)
|
49 Participants
|
37 Participants
|
58 Participants
|
Adverse Events
SYM-1219 Low Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SYM-1219 High Dose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SYM-1219 Low Dose
n=71 participants at risk
Administered orally
SYM-1219
|
SYM-1219 High Dose
n=72 participants at risk
Administered orally
SYM-1219
|
Placebo
n=72 participants at risk
Administered orally
Placebo
|
|---|---|---|---|
|
Nervous system disorders
headache
|
1.4%
1/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Nervous system disorders
dizziness
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Vaginal odor
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
1.4%
1/71
|
0.00%
0/72
|
0.00%
0/72
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.4%
1/71
|
0.00%
0/72
|
0.00%
0/72
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/71
|
0.00%
0/72
|
0.00%
0/72
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Investigations
ALT increased
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Investigations
AST increased
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoid tumor
|
1.4%
1/71
|
0.00%
0/72
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/71
|
0.00%
0/72
|
1.4%
1/72
|
|
Infections and infestations
Candida
|
1.4%
1/71
|
0.00%
0/72
|
0.00%
0/72
|
|
Infections and infestations
Chlamydia
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Infections and infestations
Fungal infection
|
1.4%
1/71
|
0.00%
0/72
|
1.4%
1/72
|
|
Infections and infestations
Gonorrhea
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Infections and infestations
Pyelonephritis
|
1.4%
1/71
|
0.00%
0/72
|
0.00%
0/72
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Infections and infestations
Vaginal mycosis
|
0.00%
0/71
|
2.8%
2/72
|
1.4%
1/72
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/71
|
1.4%
1/72
|
1.4%
1/72
|
|
Infections and infestations
Tooth infection
|
0.00%
0/71
|
1.4%
1/72
|
0.00%
0/72
|
|
Infections and infestations
Upper respiratory
|
0.00%
0/71
|
2.8%
2/72
|
2.8%
2/72
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/71
|
0.00%
0/72
|
1.4%
1/72
|
|
Infections and infestations
Vaginal candidiasis
|
1.4%
1/71
|
0.00%
0/72
|
1.4%
1/72
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place