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

Bionomics

Status and phase

Enrolling

Phase 3

Conditions

Social Anxiety Disorder

Treatments

Drug: Placebo

Drug: 225 mg BNC210

Study type

Interventional

Funder types

Industry

Identifiers

NCT06510504

BNC210.014

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study medication (225 mg BNC210 or placebo) and approximately 1 hour later participate in a behavioral assessment task. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Enrollment

332 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.