ENX-102 for Social Anxiety Disorder

Recruiting at 17 trial locations

Overseen By Kimberly Vanover, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Engrail Therapeutics INC

Must not be taking: Benzodiazepines, Psychoactive substances

Disqualifiers: Neurocognitive, Psychotic, Bipolar, Depression, others

Prior Safety Data This treatment has passed at least one previous human trial

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ENX-102, a new treatment, to determine if it reduces anxiety in individuals with social anxiety disorder (SAD) during social situations. Researchers aim to assess the treatment's effectiveness and safety. Participants will receive either the experimental treatment or a placebo (a pill with no active ingredients) over several weeks. The trial seeks individuals diagnosed with social anxiety disorder who experience significant anxiety in social settings. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications and supplements before starting and during the study. If you're taking any medications or supplements, you may need to stop them for a certain period before joining the trial.

Is there any evidence suggesting that ENX-102 is likely to be safe for humans?

Research has shown that ENX-102 has been tested for safety in people with anxiety disorders. In earlier studies involving individuals with generalized anxiety, ENX-102 was well-tolerated. Most side effects were mild, such as headaches or fatigue.

ENX-102 can be taken once daily without the need to gradually increase the dose, suggesting it is generally safe for regular use. While this study lacks information on serious side effects, existing evidence supports its safety for those with anxiety.

As this trial is in the early stages, new safety information may emerge. However, based on earlier findings, ENX-102 appears to have a manageable safety profile for those considering participation in the study for social anxiety disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for social anxiety disorder?

Unlike the standard treatments for social anxiety disorder, which often include SSRIs like sertraline or SNRIs like venlafaxine, ENX-102 offers a novel approach. Researchers are excited about ENX-102 because it may work faster, showing effectiveness in just a few weeks compared to the longer onset time of traditional medications. Additionally, ENX-102 could have a unique mechanism of action that targets the brain's neurotransmitter systems differently, potentially leading to fewer side effects. This innovative approach could provide a new option for those who don't respond well to existing therapies.

What evidence suggests that ENX-102 might be an effective treatment for social anxiety disorder?

Research has shown that ENX-102, which participants in this trial may receive, might help treat social anxiety disorder (SAD). Early studies suggest that ENX-102 affects specific brain areas linked to anxiety. This could reduce anxiety symptoms, making social situations feel less overwhelming. Although more information is needed, the initial results are promising for people with SAD. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with social anxiety disorder (SAD), confirmed by specific assessments. Participants must have certain scores indicating SAD severity and can't have a more dominant psychiatric condition, recent substance abuse, or be using psychoactive substances during the trial.

Exclusion Criteria

Have you been diagnosed with a psychotic disorder?

Have you been diagnosed with schizophrenia?

Are you currently being treated for or experiencing symptoms of PTSD?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ENX-102

Trial Overview The study tests ENX-102's effectiveness and safety against a placebo in treating SAD. It's double-blind, meaning neither participants nor researchers know who receives the actual drug or placebo until after the results are collected.

How Is the Trial Designed?

Group I: ENX-102 Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Engrail Therapeutics INC

Lead Sponsor

Trials

3

Recruited

320+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07193563

A Study to Evaluate the Efficacy and Safety of ENX-102 in ... 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 ...

2. engrail.com engrail.com/enx-102/

ENX-102 The efficacy and safety of ENX-102 as a ... Finally, a phase 2 study in social anxiety disorder is planned to initiate in the third quarter of 2025.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07193563/a-study-to-evaluate-the-efficacy-and-safety-of-enx-102-in-participants-with-social-anxiety-disorder?id=483&slug=social-anxiety-disorder-sad

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

4. withpower.com withpower.com/clinical-trials/for-social-anxiety-disorder

Top Social Anxiety Disorder Clinical Trials | Power This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD). Trial Details. Trial Status: ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/condition/483/social-anxiety-disorder-sad

Social Anxiety Disorder Sad Clinical Research Trials A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder. Phase. 2. Span. 82 weeks. Sponsor. Engrail Therapeutics INC.

6. mdpi.com mdpi.com/2073-4409/14/20/1575

Translational Insights from Rodent and Human Studies After completion of ENX-102 dosing, all rats (N = 12) received a single dose of lorazepam and EEG was recorded. All animals were habituated to dosing (vehicle ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06653296

A Dose-Response Safety Study of ENX-102 in Patients ... Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension ...

8. engrail.com engrail.com/engrail-therapeutics-initiates-the-encalm-phase-2-clinical-trial-of-enx-102-in-patients-with-generalized-anxiety-disorder/

Engrail Therapeutics Initiates the ENCALM Phase 2 ... ENX-102 exhibits a long half-life and can be dosed once daily without titration. These data support further evaluation of ENX-102 for efficacy ...