Trial Outcomes & Findings for A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder (NCT NCT05193409)
NCT ID: NCT05193409
Last Updated: 2025-03-18
Results Overview
The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Assessed over a single visit: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
225 mg BNC210
225 mg BNC210 tablet single dose
|
675 mg BNC210
675 mg BNC210 tablet single dose
|
Placebo
Placebo tablet single dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
50
|
|
Overall Study
COMPLETED
|
50
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
225 mg BNC210
n=50 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=51 Participants
675 mg BNC210 tablet single dose
|
Placebo
n=50 Participants
Placebo tablet single dose
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 11.55 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 12.86 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 11.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
108 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (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
|
|
Liebowitz Social Anxiety Scale (LSAS)
|
98.7 units on a scale
STANDARD_DEVIATION 15.75 • n=5 Participants
|
98.3 units on a scale
STANDARD_DEVIATION 16.98 • n=7 Participants
|
95.3 units on a scale
STANDARD_DEVIATION 16.34 • n=5 Participants
|
97.4 units on a scale
STANDARD_DEVIATION 16.33 • n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed over a single visit: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.
Outcome measures
| Measure |
225 mg BNC210
n=50 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=51 Participants
675 mg BNC210 tablet single dose
|
Placebo
n=50 Participants
Placebo tablet single dose
|
|---|---|---|---|
|
Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
|
22.42 score on a scale
Interval 15.78 to 29.06
|
24.26 score on a scale
Interval 17.7 to 30.82
|
29.03 score on a scale
Interval 22.44 to 35.62
|
SECONDARY outcome
Timeframe: Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.
Outcome measures
| Measure |
225 mg BNC210
n=50 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=51 Participants
675 mg BNC210 tablet single dose
|
Placebo
n=50 Participants
Placebo tablet single dose
|
|---|---|---|---|
|
Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge
|
15.18 score on a scale
Interval 9.57 to 20.79
|
12.86 score on a scale
Interval 7.31 to 18.41
|
18.95 score on a scale
Interval 13.37 to 24.52
|
SECONDARY outcome
Timeframe: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.The STAI-State is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety.
Outcome measures
| Measure |
225 mg BNC210
n=50 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=51 Participants
675 mg BNC210 tablet single dose
|
Placebo
n=50 Participants
Placebo tablet single dose
|
|---|---|---|---|
|
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score
|
3.83 score on a scale
Interval 0.17 to 7.5
|
3.04 score on a scale
Interval -0.06 to 6.69
|
4.71 score on a scale
Interval 1.04 to 8.39
|
SECONDARY outcome
Timeframe: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.The STAI-State is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety.
Outcome measures
| Measure |
225 mg BNC210
n=50 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=51 Participants
675 mg BNC210 tablet single dose
|
Placebo
n=50 Participants
Placebo tablet single dose
|
|---|---|---|---|
|
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score
|
5.77 score on a scale
Interval 2.77 to 8.78
|
5.45 score on a scale
Interval 2.47 to 8.43
|
9.04 score on a scale
Interval 6.04 to 12.04
|
SECONDARY outcome
Timeframe: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.
Outcome measures
| Measure |
225 mg BNC210
n=50 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=51 Participants
675 mg BNC210 tablet single dose
|
Placebo
n=50 Participants
Placebo tablet single dose
|
|---|---|---|---|
|
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score
|
-1.54 score on a scale
Interval -3.07 to -0.01
|
-1.79 score on a scale
Interval -3.34 to -0.24
|
-0.77 score on a scale
Interval -2.29 to 0.75
|
SECONDARY outcome
Timeframe: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.
Outcome measures
| Measure |
225 mg BNC210
n=50 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=51 Participants
675 mg BNC210 tablet single dose
|
Placebo
n=50 Participants
Placebo tablet single dose
|
|---|---|---|---|
|
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score
|
-0.38 score on a scale
Interval -1.72 to 0.97
|
-2.69 score on a scale
Interval -4.05 to -1.33
|
-1.25 score on a scale
Interval -2.58 to 0.08
|
POST_HOC outcome
Timeframe: Assessed over a single visit: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.Population: To increase the sample size for the post-hoc analysis, data were combined for the two active BNC210 treatment groups versus placebo. Only participants who completed the public speaking challenge were included.
The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.
Outcome measures
| Measure |
225 mg BNC210
n=85 Participants
225 mg BNC210 tablet single dose
|
675 mg BNC210
n=47 Participants
675 mg BNC210 tablet single dose
|
Placebo
Placebo tablet single dose
|
|---|---|---|---|
|
Change From Baseline in the Area Under the Curve (AUC) of the Combined SUDS Scores of the Anticipation and Performance Phases of a Public Speaking Challenge.
|
229.1 score on a scale * minutes
Interval 170.7 to 287.4
|
325.9 score on a scale * minutes
Interval 250.4 to 401.4
|
—
|
Adverse Events
225 mg BNC210
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
675 mg BNC210
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
225 mg BNC210
n=50 participants at risk
225 mg BNC210 single dose
|
675 mg BNC210
n=51 participants at risk
675 mg BNC210 single dose
|
Placebo
n=50 participants at risk
Placebo single dose
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
4.0%
2/50 • 1 week
|
11.8%
6/51 • 1 week
|
4.0%
2/50 • 1 week
|
|
Nervous system disorders
Headache
|
6.0%
3/50 • 1 week
|
3.9%
2/51 • 1 week
|
2.0%
1/50 • 1 week
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • 1 week
|
5.9%
3/51 • 1 week
|
0.00%
0/50 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place