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

A Phase 3, Randomized, Double-blind, 2-arm, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute, As-needed Treatment of Anxiety in Adults With Social Anxiety Disorder

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: Placebo; Drug: 225 mg BNC210

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91316
      • AFFIRM-1 Study Site
    • La Jolla, California, United States, 92037
      • AFFIRM-1 Study Site
    • Los Angeles, California, United States, 90025
      • AFFIRM-1 Study Site
    • Oceanside, California, United States, 92056
      • AFFIRM-1 Study Site
    • San Diego, California, United States, 92103
      • AFFIRM-1 Study Site
    • San Jose, California, United States, 95124
      • AFFIRM-1 Study Site
    • Sherman Oaks, California, United States, 91403
      • AFFIRM-1 Study Site
    • Temecula, California, United States, 92591
      • AFFIRM-1 Study Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • AFFIRM-1 Study Site
    • Lauderhill, Florida, United States, 33319
      • AFFIRM-1 Study Site
    • Miami Lakes, Florida, United States, 33016
      • AFFIRM-1 Study Site
    • Orlando, Florida, United States, 32801
      • AFFIRM-1 Study Site
    • Tampa, Florida, United States, 33607
      • AFFIRM-1 Study Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • AFFIRM-1 Study Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • AFFIRM-1 Study Site
    • Boston, Massachusetts, United States, 02131
      • AFFIRM-1 Study Site
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • AFFIRM-1 Study Site
  • New York
    • Brooklyn, New York, United States, 11229
      • AFFIRM-1 Study Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • AFFIRM-1 Study Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • AFFIRM-1 Study Site
  • Texas
    • Austin, Texas, United States, 78737
      • AFFIRM-1 Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: 225 mg BNC210	Drug: 225 mg BNC210; 225 mg BNC210

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge	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	Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Performance Phase conducted at 65 to 70 minutes post-dose (following the Anticipation Phase that started at 60 min).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge	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.	Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Anticipation Phase conducted at 60 to 62 minutes post-dose (the first 2 minutes of the Public Speaking Challenge).
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	The CGI-S measures overall disease severity of the participant's symptoms as scored by a clinician. Severity is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill of patients) with a higher score indicating a higher level of disease severity.	Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).
Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score	The PGI-I is a patient self-reported counterpart of the CGI designed to assess the patient's impression of their perceived change in overall symptoms. Improvement is rated from 1 (very much improved) to 7 (very much worse) with a higher score indicating a higher level of disease severity.	Assessed over a single visit: On the treatment day at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).
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	The State-Trait Anxiety Inventory (State component; 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.	Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).

Collaborators and Investigators

• Sponsor: Bionomics Limited

Publications and helpful links

Helpful Links

• Study information and pre-screening portal for potential participants

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Actual): September 11, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: BNC210.014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No