RECRUITING

ENX-102 Phase 2 Social Anxiety Disorder

Conditions

Social Anxiety Disorder (SAD)Social Anxiety ENX-102

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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

Quick Facts

Study Start:2025-09-05

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07193563

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Eve M Taylor, PhD

CONTACT

18583425478

eve.taylor@engrail.com

Kimberly Vanover, PhD

CONTACT

Kimberly.vanover@engrail.com

Study Locations (Sites)

IMA Clinical Research Phoenix

Phoenix, Arizona, 85012

United States

Excell Research, Inc.

Oceanside, California, 92056

United States

CNS Health

Jacksonville, Florida, 32256

United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801

United States

Redbird Research

Las Vegas, Nevada, 89119

United States

Cenexel HRI

Berlin, New Jersey, 08009

United States

Austin Clinical Trials Partners

Austin, Texas, 78737

United States

Grayline Research Center

Wichita Falls, Texas, 76309

United States

Collaborators and Investigators

Sponsor: Engrail Therapeutics INC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-05

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-09-05

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

Social Anxiety
ENX-102

Additional Relevant MeSH Terms

Social Anxiety Disorder (SAD)