A Phase 3 interventional study of KarXT and Placebo in Schizophrenia, sponsored by Bristol-Myers Squibb. Recruiting at 56 sites in Japan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 250 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Drug: KarXT
Other: Placebo
Specified dose on specified days
Also known as: BMS-986510
Specified dose on specified days
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Double-Blind Part
Time frame: At week 5
Number of participants with treatment-emergent adverse events (TEAEs)
Open-label extension (OLE) Part
Time frame: At Week 52 from OLE baseline
Change from baseline in PANSS positive score
Double-blind Part
Time frame: At week 5
Change from baseline in PANSS negative score
Double-blind Part
Time frame: At week 5
Change from baseline in PANSS Negative Marder Factor score
Double-blind Part
Time frame: At week 5
Change from baseline in Clinical Global Impressions-Severity (CGI-S) score
Double-blind Part
Time frame: At week 5
The percentage of PANSS responders (a ≥ 30% change in PANSS total score)
Double-blind Part
Time frame: At week 5
Number of participants wtih adverse events (AEs)
Double-blind Part
Time frame: Up to day 35
Number of participants wtih adverse events of special interest (AESIs)
Time frame: Up to week 57
Number of participants with procholinergic symptoms
Time frame: Up to week 57
Number of participants with anticholinergic symptoms
Time frame: Up to week 57
Change from baseline in Simpson-Angus Scale (SAS) score
Double-blind Part
Time frame: Up to day 35
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Double-blind Part
Time frame: Up to day 35
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Double-blind Part
Time frame: Up to day 35
Change from baseline in body weight
Double-blind Part
Time frame: Up to day 35
Change from baseline in body mass index (BMI)
Double-blind Part
Time frame: Up to day 35
Blood pressure (BP) sitting and standing after 2 minutes
Time frame: Up to week 57
Heart rate (HR) sitting and standing after 2 minutes
Time frame: Up to week 57
Number of participants wtih a change from baseline in hematology evaluations
Time frame: Up to week 57
Number of participants wtih a change from baseline in clinical chemistry evaluations
Time frame: Up to week 57
Number of participants wtih a change from baseline in coagulation evaluations
Time frame: Up to week 57
Number of participants wtih a change from baseline in urinalysis evaluations
Time frame: Up to week 57
Number of participants wtih a change from baseline in drug screen evaluations
Time frame: Up to week 57
Number of participants wtih a change from baseline in 12-lead electrocardiogram (ECG) evaluations
Time frame: Up to week 57
Number of participants wtih physical examination abnormalities
Time frame: Up to week 57
Number of participants wtih suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to week 57
International Prostate Symptom Score (IPSS)
Male participants ≥ 45 years of age only
Time frame: Up to week 57
Area under the plasma concentration-time curve (AUC)
Double-blind Part
Time frame: Up to day 35
Maximum observed plasma concentration (Cmax)
Double-blind Part
Time frame: Up to day 35
Time of maximum observed plasma concentration (Tmax)
Double-blind Part
Time frame: Up to day 35
Number of participants wtih serious TEAEs
OLE Part
Time frame: Up to week 57
Number of participants wtih TEAEs leading to discontinuation of study intervention
OLE Part
Time frame: Up to week 57
Change from OLE baseline in PANSS total score
OLE Part
Time frame: At week 57
Change from OLE baseline in CGI-S score
OLE Part
Time frame: At week 57
Percentage of PANSS responders
OLE Part
Time frame: At week 57
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb