Recruiting
Phase 3

KarXT

Sponsor:

Bristol-Myers Squibb

Code:

NCT07288567

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

KarXT

KarXT Matching Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

Conditions

Schizophrenia

Study ID

NCT07288567

Start date

Jan 29, 2026

Status verified date

Sep, 2026

Completion date

Dec 18, 2029

Anticipated

Primary completion date

Dec 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).
  • PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
  • Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).

Exclusion Criteria:

  • Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.
  • History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
  • All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
  • Any neurological disorder, except for Tourette's Syndrome.
  • Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

166 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT

placebo comparator: Placebo

Interventions

KarXT

Specified dose on specified days

KarXT Matching Placebo

Specified dose on specified days

Primary outcome measure

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Week 5 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Advanced Research Center Inc.

Recruiting

Anaheim, California, United States, 92805

Contacts

Steven Macina, Site 0077

714-999-6688

Inland Psychiatric Medical Group.

Recruiting

Chino, California, United States, 91710

Contacts

Nandita Puchakayala, Site 0058

909-488-9116

Proscience Research Group

Recruiting

Culver City, California, United States, 90230

Contacts

Marina Bussel, Site 0024

424-227-8127

UCSF Neurosciences Clinical Research Unit (NCRU)

Recruiting

San Francisco, California, United States, 94158

Contacts

Danai Nyasha Chagwedera, Site 0089

415-861-9288

Apg Research, Llc

Recruiting

Orlando, Florida, United States, 32803

Contacts

Morteza Nadjafi, Site 0032

407-423-7149

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Elyssa Barron, Site 0057

404-881-5800

Salveo Integrative Health - Lawrenceville

Recruiting

Lawrenceville, Georgia, United States, 30046

Denali Health Atlanta, LLC

Recruiting

Stone Mountain, Georgia, United States, 30083

EmVenio Research Center - Prime Healthcare

Recruiting

Chicago, Illinois, United States, 60622

Contacts

Mitchell Glaser, Site 0044

773-620-2995

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience

Recruiting

Cincinnati, Ohio, United States, 45219

VAST Clinical Research

Recruiting

Garland, Texas, United States, 75043

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-04.