Social Anxiety Disorder (SAD)Phase 2NCT07193563
A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder
A Phase 2 study testing ENX-102 in people with Social Anxiety Disorder (SAD), run by Engrail Therapeutics INC at 20 sites in United States.
Trial summary
This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Social Anxiety Disorder (SAD)
- What is being tested?
- ENX-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 20 sitesUnited States
- Study dates
- 5 Sep 2025to 19 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Austin Clinical Trials Partners
Austin, Texas, 78737
Cenexel HRI
Berlin, New Jersey, 08009
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Mountain View Clinical Research
Denver, Colorado, 80209
Core Clinical Research
Everett, Washington, 98201
CNS Health
Jacksonville, Florida, 32256
University of California
La Jolla, California, 92037
IMA Clinical Research
Las Vegas, Nevada, 89102
Redbird Research
Las Vegas, Nevada, 89119
Neuroresearch Group
Los Angeles, California, 90025
Clinical Neurosciences, Inc
Memphis, Tennessee, 38119
Excell Research, Inc.
Oceanside, California, 92056
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
IMA Clinical Research Phoenix
Phoenix, Arizona, 85012
Anderson Clinical Research
Redlands, California, 92374
CenExel iResearch, LLC
Savannah, Georgia, 31405
California Neuroscience Research, LLC
Sherman Oaks, California, 91403
Sunwise Clincial Research
Walnut Creek, California, 94596
Grayline Research Center
Wichita Falls, Texas, 76309
About this study
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
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)
- Being tested
- ENX-102, Placebo
- Keywords
- Social Anxiety, ENX-102
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENX-102Drug
oral capsule
PlaceboOther
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ENX-102 |
| Placebo | Placebo comparator | Participants will receive ENX-102 matching placebo in capsule once daily for 10 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start5 Sep 2025
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engrail Therapeutics INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193563
- Sponsor's protocol ID
- ENX-102-005
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07193563
- Acronym / sponsor ID
- ENX-102-005
- Conditions
- Social Anxiety Disorder (SAD)
- Keywords
- Social Anxiety, ENX-102
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Engrail Therapeutics INCIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENX-102 | Experimental | Drug: ENX-102Participants 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive ENX-102 matching placebo in capsule once daily for 10 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENX-102oral capsule | Drug | ENX-102 |
| Placebooral capsule | Other | Placebo |
Primary outcome
Change From Baseline on the Clinician-administered Liebowitz Social Anxiety Scale (LSAS) - Total score
Time frame: Baseline (Day 1) and Week 6
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENX-102 in people with Social Anxiety Disorder (SAD), run by Engrail Therapeutics INC at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on the Clinician-administered Liebowitz Social Anxiety Scale (LSAS) - Total score (time frame: Baseline (Day 1) and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.