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NCT Number: NCT06882785

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hotei Hospital, Kōnan, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Other names: BMS-986510

Placebo

Other

Specified dose on specified days

Primary outcomes

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

    Time frame: At week 5

    Double-Blind Part

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

    Time frame: At Week 52 from OLE baseline

    Open-label extension (OLE) Part

Secondary outcomes

  1. Change from baseline in PANSS positive score

    Time frame: At week 5

    Double-blind Part

  2. Change from baseline in PANSS negative score

    Time frame: At week 5

    Double-blind Part

  3. Change from baseline in PANSS Negative Marder Factor score

    Time frame: At week 5

    Double-blind Part

  4. Change from baseline in Clinical Global Impressions-Severity (CGI-S) score

    Time frame: At week 5

    Double-blind Part

  5. The percentage of PANSS responders (a ≥ 30% change in PANSS total score)

    Time frame: At week 5

    Double-blind Part

  6. Number of participants wtih adverse events (AEs)

    Time frame: Up to day 35

    Double-blind Part

  7. Number of participants wtih adverse events of special interest (AESIs)

    Time frame: Up to week 57

  8. Number of participants with procholinergic symptoms

    Time frame: Up to week 57

  9. Number of participants with anticholinergic symptoms

    Time frame: Up to week 57

  10. Change from baseline in Simpson-Angus Scale (SAS) score

    Time frame: Up to day 35

    Double-blind Part

  11. Change from baseline in Barnes Akathisia Rating Scale (BARS) score

    Time frame: Up to day 35

    Double-blind Part

  12. Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score

    Time frame: Up to day 35

    Double-blind Part

  13. Change from baseline in body weight

    Time frame: Up to day 35

    Double-blind Part

  14. Change from baseline in body mass index (BMI)

    Time frame: Up to day 35

    Double-blind Part

  15. Blood pressure (BP) sitting and standing after 2 minutes

    Time frame: Up to week 57

  16. Heart rate (HR) sitting and standing after 2 minutes

    Time frame: Up to week 57

  17. Number of participants wtih a change from baseline in hematology evaluations

    Time frame: Up to week 57

  18. Number of participants wtih a change from baseline in clinical chemistry evaluations

    Time frame: Up to week 57

  19. Number of participants wtih a change from baseline in coagulation evaluations

    Time frame: Up to week 57

  20. Number of participants wtih a change from baseline in urinalysis evaluations

    Time frame: Up to week 57

  21. Number of participants wtih a change from baseline in drug screen evaluations

    Time frame: Up to week 57

  22. Number of participants wtih a change from baseline in 12-lead electrocardiogram (ECG) evaluations

    Time frame: Up to week 57

  23. Number of participants wtih physical examination abnormalities

    Time frame: Up to week 57

  24. Number of participants wtih suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to week 57

  25. International Prostate Symptom Score (IPSS)

    Time frame: Up to week 57

    Male participants ≥ 45 years of age only

  26. Area under the plasma concentration-time curve (AUC)

    Time frame: Up to day 35

    Double-blind Part

  27. Maximum observed plasma concentration (Cmax)

    Time frame: Up to day 35

    Double-blind Part

  28. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to day 35

    Double-blind Part

  29. Number of participants wtih serious TEAEs

    Time frame: Up to week 57

    OLE Part

  30. Number of participants wtih TEAEs leading to discontinuation of study intervention

    Time frame: Up to week 57

    OLE Part

  31. Change from OLE baseline in PANSS total score

    Time frame: At week 57

    OLE Part

  32. Change from OLE baseline in CGI-S score

    Time frame: At week 57

    OLE Part

  33. Percentage of PANSS responders

    Time frame: At week 57

    OLE Part

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 19, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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