A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder (PREVAIL)

A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of BNC210 Compared to Placebo for the Acute Treatment of Social Anxiety Disorder

The purpose of this study is to assess the effects of an acute dose of BNC210 compared to placebo on reducing anxiety provoked by a speaking challenge and measured using the Subjective Units of Distress Scale (SUDS) in patients with Social Anxiety Disorder (SAD).

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: Placebo; Drug: 225 mg BNC210; Drug: 675 mg BNC210

Detailed Description

This is a randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 14 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study intervention (225 mg BNC210, 675 mg BNC210 or placebo) and approximately 1 hour later participate in a speaking challenge. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • PREVAIL Study Clinical Trial Site
    • Encino, California, United States, 91316
      • PREVAIL Study Clinical Trial Site
    • Glendale, California, United States, 91204
      • PREVAIL Study Clinical Trial Site
  • Connecticut
    • New Haven, Connecticut, United States, 33122
      • PREVAIL Study Clinical Trial Site
  • Florida
    • Lauderhill, Florida, United States, 33319
      • PREVAIL Study Clinical Trial Site
    • Miami, Florida, United States, 33122
      • PREVAIL Study Clinical Trial Site
    • Miami Lakes, Florida, United States, 33016
      • PREVAIL Study Clinical Trial Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • PREVAIL Study Clinical Trial Site
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • PREVAIL Study Clinical Trial Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • PREVAIL Study Clinical Trial Site
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • PREVAIL Study Clinical Trial Site
  • New York
    • Brooklyn, New York, United States, 11229
      • PREVAIL Study Clinical Trial Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • PREVAIL Study Clinical Trial Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • PREVAIL Study Clinical Trial Site
  • Utah
    • Draper, Utah, United States, 84020
      • PREVAIL Study Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has a current diagnosis of Social Anxiety Disorder (SAD) as defined in DSM-5 and confirmed by Structured Clinical Interview for DSM-5 Disorders - Clinical Trials version (SCID-5-CT).
• Liebowitz Social Anxiety Scale (LSAS) total score of ≥70
• Suitable contraception use in line with protocol requirements
• Ability to swallow tablets

Exclusion Criteria:

• History of schizophrenia, bipolar disorder, or psychotic disorders, or has a current clinically predominant diagnosis of any other Axis I disorder, other than SAD
• Hamilton Rating Scale for Depression (HAM-D) 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.
• Previous participation in a study that involved a speaking challenge.
• 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

3

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
Experimental: 675 mg BNC210	Drug: 675 mg BNC210; 675 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: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

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: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score	The 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: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score	The 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: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score	The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.	Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score	The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.	Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

Collaborators and Investigators

• Sponsor: Bionomics Limited

Publications and helpful links

General Publications

• Papapetropoulos S, Doolin E, Odontiadis M, Paul D, Jaros M, Rolan P, Taylor C, Stein MB. A phase 2, placebo-controlled study to evaluate the efficacy and safety of BNC210, an alpha-7 nicotinic receptor negative allosteric modulator, for acute, as-needed treatment of social anxiety disorder (SAD) - The PREVAIL study. Psychiatry Res. 2025 Apr;346:116387. doi: 10.1016/j.psychres.2025.116387. Epub 2025 Feb 10.

Helpful Links

• further study information for potential participants

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Phobia, Social; Anxiety Disorders
• Other Study ID Numbers: BNC210.013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No