Recruiting
Phase 3

KarXT

Sponsor:

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Code:

NCT07686263

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Xanomeline/Trospium Chloride

Placebo

Study Details

Brief summary:

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Conditions

Schizophrenia

Study ID

NCT07686263

Start date

Aug 20, 2026

Status verified date

Sep, 2026

Completion date

Mar 3, 2029

Anticipated

Primary completion date

Mar 3, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
  • Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
  • Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
  • Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:

1. Item 1 (P1; delusions)
2. Item 2 (P2; conceptual disorganization)
3. Item 3 (P3; hallucinatory behavior)
4. Item 6 (P6; suspiciousness/persecution)
  • Participant must have a CGI-S score of ≥ 4 at screening and Day -1
  • Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

Exclusion Criteria

  • Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
  • Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
  • Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
  • Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
  • Participant must not have a history of treatment resistance to schizophrenia medications
  • Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

472 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT

placebo comparator: Placebo

Interventions

Xanomeline/Trospium Chloride

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

  • Time From Randomization to the First Relapse Event [ Time Frame: Up to approximately Week 43 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Pillar Clinical Research - Bentonville

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Fayz Hudefi, Site 0154

479-367-2688

Pillar Clinical Research- Little Rock

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Leslie Smith, Site 0139

501-350-3285

Research Centers of America ( Hollywood )

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Edwin Gomez, Site 0145

954-604-3900

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Elyssa Barron, Site 0166

404-881-5800

Pillar Clinical Research - Richardson

Recruiting

Richardson, Texas, United States, 75080

Contacts

Scott Bartley, Site 0133

214-396-4844

More Information

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • KarXT
  • Cobenfy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Karuna Therapeutics, Inc., a Bristol Myers Squibb company on 2026-09-14.