Social Anxiety DisorderPhase 3AFFIRM-1NCT06510504
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
A Phase 3 study testing 225 mg BNC210 in people with Social Anxiety Disorder, run by Bionomics Limited at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- 225 mg BNC210
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 21 sitesUnited States
- Study dates
- 6 Aug 2024to 19 Sep 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
AFFIRM-1 Study Site
Austin, Texas, 78737
AFFIRM-1 Study Site
Boston, Massachusetts, 02114
AFFIRM-1 Study Site
Boston, Massachusetts, 02131
AFFIRM-1 Study Site
Brooklyn, New York, 11229
AFFIRM-1 Study Site
Charlotte, North Carolina, 28211
AFFIRM-1 Study Site
Decatur, Georgia, 30030
AFFIRM-1 Study Site
Encino, California, 91316
AFFIRM-1 Study Site
Jacksonville, Florida, 32256
AFFIRM-1 Study Site
La Jolla, California, 92037
AFFIRM-1 Study Site
Lauderhill, Florida, 33319
AFFIRM-1 Study Site
Los Angeles, California, 90025
AFFIRM-1 Study Site
Media, Pennsylvania, 19063
AFFIRM-1 Study Site
Miami Lakes, Florida, 33016
AFFIRM-1 Study Site
Oceanside, California, 92056
AFFIRM-1 Study Site
Orlando, Florida, 32801
AFFIRM-1 Study Site
Princeton, New Jersey, 08540
AFFIRM-1 Study Site
San Diego, California, 92103
AFFIRM-1 Study Site
San Jose, California, 95124
AFFIRM-1 Study Site
Sherman Oaks, California, 91403
AFFIRM-1 Study Site
Tampa, Florida, 33607
AFFIRM-1 Study Site
Temecula, California, 92591
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- 225 mg BNC210, Placebo
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
225 mg BNC210Drug
225 mg BNC210
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 225 mg BNC210 | Experimental | Not described Receives: Drug: 225 mg BNC210 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start6 Aug 2024
- Primary completion11 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionomics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510504
- Sponsor's protocol ID
- BNC210.014
- Acronym
- AFFIRM-1
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2024
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06510504
- Acronym / sponsor ID
- AFFIRM-1 / BNC210.014
- Conditions
- Social Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Bionomics LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 225 mg BNC210 | Experimental | Drug: 225 mg BNC210 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 225 mg BNC210225 mg BNC210 | Drug | 225 mg BNC210 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
Time frame: 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).
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
4 secondary outcomes
Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study information and pre-screening portal for potential participantsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 225 mg BNC210 in people with Social Anxiety Disorder, run by Bionomics Limited at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.