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

Engrail Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Social Anxiety Disorder (SAD)

Treatments: Drug: ENX-102; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07193563

ENX-102-005

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

220 participants in 2 patient groups, including a placebo group

ENX-102

Experimental group

Description:

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.

Treatment:

Drug: ENX-102

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo