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
1 other identifier
interventional
370
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2024
Shorter than P25 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2024
CompletedFirst Posted
Study publicly available on registry
July 19, 2024
CompletedStudy Start
First participant enrolled
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2025
CompletedOctober 24, 2025
September 1, 2025
1.1 years
July 15, 2024
October 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective Units of Distress Scale (SUDS)
The Subjective Units of Distress Scale (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.
1 day
Secondary Outcomes (3)
Clinical Global Impressions-Severity (CGI-S)
1 day
Patient Global Impressions-Improvement (PGI-I)
1 day
State-Trait Anxiety Inventory (State Component; STAI-State)
1 day
Study Arms (2)
225 mg BNC210
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
AFFIRM-1 Study Site
Encino, California, 91316, United States
AFFIRM-1 Study Site
La Jolla, California, 92037, United States
AFFIRM-1 Study Site
Los Angeles, California, 90025, United States
AFFIRM-1 Study Site
Oceanside, California, 92056, United States
AFFIRM-1 Study Site
San Diego, California, 92103, United States
AFFIRM-1 Study Site
San Jose, California, 95124, United States
AFFIRM-1 Study Site
Sherman Oaks, California, 91403, United States
AFFIRM-1 Study Site
Temecula, California, 92591, United States
AFFIRM-1 Study Site
Jacksonville, Florida, 32256, United States
AFFIRM-1 Study Site
Lauderhill, Florida, 33319, United States
AFFIRM-1 Study Site
Miami Lakes, Florida, 33016, United States
AFFIRM-1 Study Site
Orlando, Florida, 32801, United States
AFFIRM-1 Study Site
Tampa, Florida, 33607, United States
AFFIRM-1 Study Site
Decatur, Georgia, 30030, United States
AFFIRM-1 Study Site
Boston, Massachusetts, 02114, United States
AFFIRM-1 Study Site
Boston, Massachusetts, 02131, United States
AFFIRM-1 Study Site
Princeton, New Jersey, 08540, United States
AFFIRM-1 Study Site
Brooklyn, New York, 11229, United States
AFFIRM-1 Study Site
Charlotte, North Carolina, 28211, United States
AFFIRM-1 Study Site
Media, Pennsylvania, 19063, United States
AFFIRM-1 Study Site
Austin, Texas, 78737, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2024
First Posted
July 19, 2024
Study Start
August 6, 2024
Primary Completion
September 11, 2025
Study Completion
September 19, 2025
Last Updated
October 24, 2025
Record last verified: 2025-09