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

Last updated: April 15, 2025
Sponsor: Bionomics Limited
Overall Status: Active - Recruiting

Phase

3

Condition

Anxiety Disorders

Mood Disorders

Social Phobia

Treatment

Placebo

225 mg BNC210

Clinical Study ID

NCT06510504
BNC210.014
  • Ages 18-65
  • All Genders

Study 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

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

Exclusion Criteria:

  • History of bipolar disorder, schizophrenia, schizoaffective disorder, psychoticdisorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrumdisorder or obsessive-compulsive disorder, or any other Axis I or II disorder whichis 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 (anyseverity) in the past 12 months.

  • Use of psychotropic medications within 30 days of screening. Daily use ofbenzodiazepines within 90 days of screening.

  • Any clinically significant medical history or findings as determined by theInvestigator that could interfere with the objectives of the study or put theparticipant at risk.

Study Design

Total Participants: 332
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 06, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • AFFIRM-1 Study Site

    Encino, California 91316
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Oceanside, California 92056
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    San Diego, California 92103
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    San Jose, California 95124
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Temecula, California 92591
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Lauderhill, Florida 33319
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Princeton, New Jersey 08540
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Brooklyn, New York 11229
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Media, Pennsylvania 19063
    United States

    Active - Recruiting

  • AFFIRM-1 Study Site

    Austin, Texas 78737
    United States

    Active - Recruiting

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