RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

Japan250 participantsStarted 2025-06-10

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI). * Participants must have a PANSS total score between 80 and 120, inclusive. * Participants must have a CGI-S score of ≥ 4. Exclusion Criteria * Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening. * Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia. * Participants must not have any history or presence of clinically significant medical conditions. * Other protocol-defined Inclusion/Exclusion criteria apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Timeframe: At week 5

Number of participants with treatment-emergent adverse events (TEAEs)

Timeframe: At Week 52 from OLE baseline

Trial details

NCT IDNCT06882785

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09-23

Contact for this trial

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.