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

Bionomics

Status and phase: Completed; Phase 2

Conditions: Social Anxiety Disorder

Treatments: Drug: 225 mg BNC210; Drug: 675 mg BNC210; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05193409

BNC210.013

Details and patient eligibility

About

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).

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 3 patient groups, including a placebo group

225 mg BNC210

Experimental group

Treatment:

Drug: 225 mg BNC210

675 mg BNC210

Experimental group

Treatment:

Drug: 675 mg BNC210

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo