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

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

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

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder (SAD)
• Intervention / Treatment: Drug: ENX-102; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • IMA Clinical Research Phoenix
  • California
    • La Jolla, California, United States, 92037
      • University of California
    • Los Angeles, California, United States, 90025
      • Neuroresearch Group
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research, LLC
    • Walnut Creek, California, United States, 94596
      • Sunwise Clincial Research
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
  • Florida
    • Jacksonville, Florida, United States, 32256
      • CNS Health
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
  • Georgia
    • Savannah, Georgia, United States, 31405
      • CenExel iResearch, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Ima Clinical Research
    • Las Vegas, Nevada, United States, 89119
      • Redbird Research
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • CenExel HRI
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neurosciences, Inc
  • Texas
    • Austin, Texas, United States, 78737
      • Austin Clinical Trials Partners
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
  • Washington
    • Everett, Washington, United States, 98201
      • Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: ENX-102; oral capsule
Placebo Comparator: Placebo; Participants will receive ENX-102 matching placebo in capsule once daily for 10 weeks	Other: Placebo; oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Engrail Therapeutics INC

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2025
• Primary Completion (Actual): March 19, 2026
• Study Completion (Actual): March 19, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: September 24, 2025
• First Posted (Actual): September 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Social Anxiety; ENX-102
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: ENX-102-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No