A Study to Evaluate the Efficacy and Sa… | Clinical Trial

Key information

Conditions

Social Anxiety Disorder (SAD) Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IMA Clinical Research Phoenix, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Male or female at birth, aged 18-70 years, inclusive, at screening Diagnosed with SAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
LSAS total score of ≥70
CGI-S score of ≥4

Key Exclusion Criteria:

Clinically predominant psychiatric diagnosis other than SAD per the MINI
Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
Reports moderately severe to severe symptoms of depression
Frequent use of benzodiazepines within 90 days of screening
Used prohibited medication or prohibited herbal or other supplements within 5 half- lives or 21 days prior to Day 1 and unwillingness to refrain from their use for the duration of the trial
Recent suicidal ideation or behavior
Current or recent moderate or severe substance use disorder as assessed by the MINI
Is unwilling/unable to abstain from alcohol, marijuana, THC, CBD, and/or any other psychoactive substances (except for nicotine or caffeine) for the duration of the trial, per Investigator judgment, and/or has a positive alcohol test or drug test at Screening or Day 1
Clinically significant abnormal findings in safety assessments
Has significant progressive disorders or unstable medical conditions Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study

Treatment and study plan

ENX-102

Drug

oral capsule

Placebo

Other

oral capsule

Primary outcomes

Change From Baseline on the Clinician-administered Liebowitz Social Anxiety Scale (LSAS) - Total score

Time frame: Baseline (Day 1) and Week 6

The LSAS is a 24-item semi-structured interview measure of fear and avoidance experienced in a range of social and performance situations. The 24 items are divided into 2 subscales, 13 concerning performance anxiety & 11 pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually). An overall global score (0 to 144) is calculated by adding total fear/anxiety and total avoidance scores. Higher scores indicated higher probability of social anxiety disorder.

Sponsors and collaborators

Lead sponsor

Engrail Therapeutics INC

Industry

Registry information

Official study title

The ENCalmSocial Trial: A Randomized, Double-Blind, Placebo-Controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 26, 2025
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed