Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1

Completed · Phase 3 · Has a placebo group

Conditions studied: Social Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT06510504

Run by

Bionomics Limited

People needed

370

Starts

2024-08-06

Expected to finish

2025-09-19

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• AFFIRM-1 Study Site — Encino, California, United States
• AFFIRM-1 Study Site — La Jolla, California, United States
• AFFIRM-1 Study Site — Los Angeles, California, United States
• AFFIRM-1 Study Site — Oceanside, California, United States
• AFFIRM-1 Study Site — San Diego, California, United States
• AFFIRM-1 Study Site — San Jose, California, United States
• AFFIRM-1 Study Site — Sherman Oaks, California, United States
• AFFIRM-1 Study Site — Temecula, California, United States
• AFFIRM-1 Study Site — Jacksonville, Florida, United States
• AFFIRM-1 Study Site — Lauderhill, Florida, United States
• AFFIRM-1 Study Site — Miami Lakes, Florida, United States
• AFFIRM-1 Study Site — Orlando, Florida, United States
• AFFIRM-1 Study Site — Tampa, Florida, United States
• AFFIRM-1 Study Site — Decatur, Georgia, United States
• AFFIRM-1 Study Site — Boston, Massachusetts, United States
• AFFIRM-1 Study Site — Boston, Massachusetts, United States
• AFFIRM-1 Study Site — Princeton, New Jersey, United States
• AFFIRM-1 Study Site — Brooklyn, New York, United States
• AFFIRM-1 Study Site — Charlotte, North Carolina, United States
• AFFIRM-1 Study Site — Media, Pennsylvania, United States
• AFFIRM-1 Study Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.