Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-12-09
2027-01-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NTX-1472
NTX-1472
Daily (QD) x 8 weeks.
Placebo
Placebo
Daily (QD) x 8 weeks.
Interventions
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NTX-1472
Daily (QD) x 8 weeks.
Placebo
Daily (QD) x 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Newleos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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SOAR Clinical Study Site
Pheonix, Arizona, United States
SOAR Clinical Study Site
Encino, California, United States
SOAR Clinical Study Site
Los Angeles, California, United States
SOAR Clinical Study Site
Oceanside, California, United States
SOAR Clinical Study Site
San Jose, California, United States
SOAR Clinical Study Site
Jacksonville, Florida, United States
SOAR Clinical Study Site
Tampa, Florida, United States
SOAR Clinical Study Site
Boston, Massachusetts, United States
SOAR Clinical Study Site
Brooklyn, New York, United States
SOAR Clinical Study Site
Memphis, Tennessee, United States
SOAR Clinical Study Site
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NTX-1472-201
Identifier Type: -
Identifier Source: org_study_id
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