Phase 3
N=370
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
Social Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT06510504 ↗Enrolled (actual)
370
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge — 27.2; 26.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 225 mg BNC210 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bionomics Limited
- Primary completion
- Sep 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge |
27.2; 26.0 | — |
| SECONDARY Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge |
13.3; 14.1 | — |
| SECONDARY Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Clinical Global Impressions-Severity (CGI-S) Score |
1.21; 1.06 | — |
| SECONDARY Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score |
3.74; 3.82 | — |
| SECONDARY Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score |
4.37; 3.65 | — |
Summary
The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.
Eligibility Criteria
Inclusion Criteria
- A current diagnosis of social anxiety disorder as defined in the DSM-5.
- A Liebowitz Social Anxiety Scale total score of ≥60.
- Suitable contraception use in line with protocol requirements.
- Ability to swallow tablets.
Exclusion Criteria
- History of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrum disorder or obsessive-compulsive disorder, or any other Axis I or II disorder which is currently the primary focus of treatment over social anxiety disorder.
- Hamilton Rating Scale for Depression score of ≥18.
- Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months.
- Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening.
- Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.
Data sourced from ClinicalTrials.gov (NCT06510504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.