A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder

NCT07193563 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ENX-102-005
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 20

Brief Summary

This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).

Conditions

Social Anxiety Disorder (SAD)

Keywords

Social Anxiety; ENX-102

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline (Day 1) and Week 6

Study Arms (2)

ENX-102

EXPERIMENTAL

Participants will receive 2 mg of ENX-102 in capsule form orally once daily for 6 weeks, followed by 2 weeks of tapered dose and up to 2 weeks of placebo in capsule form before and/or after the 8-week ENX-102 treatment period.

Drug: ENX-102

Placebo

PLACEBO COMPARATOR

Participants will receive ENX-102 matching placebo in capsule once daily for 10 weeks

Other: Placebo

Interventions

ENX-102 DRUG

oral capsule

ENX-102

Placebo OTHER

oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Engrail Therapeutics INC: lead

Study Sites (20)

IMA Clinical Research Phoenix

Phoenix, Arizona, 85012, United States

Location

University of California

La Jolla, California, 92037, United States

Location

Neuroresearch Group

Los Angeles, California, 90025, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

California Neuroscience Research, LLC

Sherman Oaks, California, 91403, United States

Location

Sunwise Clincial Research

Walnut Creek, California, 94596, United States

Location

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

CNS Health

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

IMA Clinical Research

Las Vegas, Nevada, 89102, United States

Location

Redbird Research

Las Vegas, Nevada, 89119, United States

Location

Cenexel HRI

Berlin, New Jersey, 08009, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Clinical Neurosciences, Inc

Memphis, Tennessee, 38119, United States

Location

Austin Clinical Trials Partners

Austin, Texas, 78737, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: September 26, 2025
• Study Start: September 5, 2025
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)