A Study of NTX-1472 in Social Anxiety Disorder (SOAR)

Newleos Therapeutics, Inc.

Status and phase

Enrolling

Phase 2

Conditions

Social Anxiety Disorder (SAD)

Treatments

Drug: NTX-1472

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07323784

NTX-1472-201

Details and patient eligibility

About

The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social Anxiety Disorder (SAD). The main questions this trial aims to answer are:

Is NTX-1472 safe and well tolerated in adults with SAD?
How effectively does NTX-1472 treat adults with SAD?

Researchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug).

Participants will:

Take NTX-1472 or matching placebo every day for 8 weeks
Visit the clinic 6 times over the course of 14 weeks for checkups and tests

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
English speaker
Male or female, ≥18 and ≤65 years of age
Current diagnosis of generalized Social Anxiety Disorder (SAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID-5-CT).
Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening
Clinician-rated Hamilton Depression Rating Scale (HDRS 17) (17 items) total score <16 at Screening
If participant is of childbearing potential, must commit to practicing effective methods of birth control during the study and at least 14 days after the last dose.

Key Exclusion Criteria

Current diagnosis of performance-only SAD as defined by the DSM-5 and confirmed by the SCID-5-CT.
Current diagnosis of any of the following psychiatric condition(s) as defined by the DSM-5 (participants with current generalized anxiety disorder may be included): Attention-deficit/hyperactivity disorder, Autism spectrum disorder, Major depressive disorder, Personality disorder, Post-traumatic stress disorder.
Past or current diagnosis of any of the following psychiatric condition(s), as defined by the DSM-5: Bipolar disorder, Feeding and eating disorder (in adulthood), Obsessive-compulsive disorder, Schizophrenia spectrum or other psychotic disorder, Substance use disorder (within 12 months of Screening).
Receiving daily psychotropics within 4 weeks of Screening
Is at risk for suicidal ideation as per C-SSRS
Has moderate or severe hepatic impairment
Has severe renal impairment
Women who are pregnant or women who are currently breastfeeding unless they are willing to stop breastfeeding for the duration of the study.