ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder

Engrail Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Placebo; Drug: ENX-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT05749055

ENX-102-003

Details and patient eligibility

About

The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
• Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
• Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1

Key Exclusion Criteria:

• Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
• Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
• Reports moderately severe to severe symptoms of depression
• Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
• Recent suicidal ideation or behavior
• Current or recent moderate to severe substance use disorder as assessed by the MINI
• 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

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280 participants in 2 patient groups, including a placebo group

ENX-102

Experimental group

Description:

Four weeks of 2 mg of ENX-102 in capsule form followed by 3 weeks of tapered dose plus 2 weeks of placebo in capsule form (before and/or after the ENX-102 treatment period), taken orally once daily in the evening for a 9-week total treatment period.

Treatment:

Drug: ENX-102

Placebo

Placebo Comparator group

Description:

Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period.

Treatment:

Drug: Placebo