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A Study of NTX-1472 in Social Anxiety Disorder

NCT07323784 · Newleos Therapeutics, Inc.
In plain English

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Official title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of NTX-1472, a V1a Receptor Antagonist, in Adults With Social Anxiety Disorder
About this study
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
Eligibility 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.
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-12-09
Estimated completion: 2027-01
Last updated: 2026-01-21
Interventions
Drug: NTX-1472Drug: Placebo
Primary outcomes
  • Incidence and severity of treatment-emergent adverse events (TEAEs) (Baseline to Week 8)
Sponsor
Newleos Therapeutics, Inc. · industry
Contacts & investigators
ContactNewleos Therapeutics Clinical Trial Team · contact · clinicaltrials@newleos.com · 978-780-5937
All locations (11)
SOAR Clinical Study SiteRecruiting
Pheonix, Arizona, United States
SOAR Clinical Study SiteRecruiting
Encino, California, United States
SOAR Clinical Study SiteRecruiting
Los Angeles, California, United States
SOAR Clinical Study SiteRecruiting
Oceanside, California, United States
SOAR Clinical Study SiteRecruiting
San Jose, California, United States
SOAR Clinical Study SiteRecruiting
Jacksonville, Florida, United States
SOAR Clinical Study SiteRecruiting
Tampa, Florida, United States
SOAR Clinical Study SiteRecruiting
Boston, Massachusetts, United States
SOAR Clinical Study SiteRecruiting
Brooklyn, New York, United States
SOAR Clinical Study SiteRecruiting
Memphis, Tennessee, United States
SOAR Clinical Study SiteRecruiting
Austin, Texas, United States
A Study of NTX-1472 in Social Anxiety Disorder · TrialPath