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

NCT ID: NCT07193563

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-05

Study Completion Date

2026-03-31

Brief Summary

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

Detailed Description

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Conditions

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Social Anxiety Disorder (SAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ENX-102

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.

Group Type EXPERIMENTAL

ENX-102

Intervention Type DRUG

oral capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

oral capsule

Interventions

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ENX-102

oral capsule

Intervention Type DRUG

Placebo

oral capsule

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Engrail Therapeutics INC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IMA Clinical Research Phoenix

Phoenix, Arizona, United States

Site Status

University of California

La Jolla, California, United States

Site Status

Neuroresearch Group

Los Angeles, California, United States

Site Status

Excell Research, Inc.

Oceanside, California, United States

Site Status

Anderson Clinical Research

Redlands, California, United States

Site Status

California Neuroscience Research, LLC

Sherman Oaks, California, United States

Site Status

Sunwise Clincial Research

Walnut Creek, California, United States

Site Status

Mountain View Clinical Research

Denver, Colorado, United States

Site Status

CNS Health

Jacksonville, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

CenExel iResearch, LLC

Savannah, Georgia, United States

Site Status

IMA Clinical Research

Las Vegas, Nevada, United States

Site Status

Redbird Research

Las Vegas, Nevada, United States

Site Status

Cenexel HRI

Berlin, New Jersey, United States

Site Status

SPRI Clinical Trials, LLC

Brooklyn, New York, United States

Site Status

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

Site Status

Clinical Neurosciences, Inc

Memphis, Tennessee, United States

Site Status

Austin Clinical Trials Partners

Austin, Texas, United States

Site Status

Grayline Research Center

Wichita Falls, Texas, United States

Site Status

Core Clinical Research

Everett, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ENX-102-005

Identifier Type: -

Identifier Source: org_study_id

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