Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder
Lead Sponsor:
Engrail Therapeutics INC
Conditions:
Social Anxiety Disorder (SAD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT07193563
Start Date
September 5 2025
End Date
March 1 2026
Last Update
January 9 2026
Active Locations (20)
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1
IMA Clinical Research Phoenix
Phoenix, Arizona, United States, 85012
2
University of California
La Jolla, California, United States, 92037
3
Neuroresearch Group
Los Angeles, California, United States, 90025
4
Excell Research, Inc.
Oceanside, California, United States, 92056