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

May 12, 2026 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Japan
      • Fukuoka, Japan, 819-0037
        • Recruiting
        • Kuramitsu Hospital
        • Contact:
          • Noriko Tamaru, Site 0008
          • Phone Number: +81-92-811-1821
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
        • Contact:
          • Anri WATANABE, Site 0048
          • Phone Number: +81-752515612
      • Miyazaki, Japan, 880-8510
        • Recruiting
        • Miyazaki Prefectural Miyazaki Hospital
        • Contact:
          • Jiro Kawano, Site 0029
          • Phone Number: 81985244181
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Contact:
          • Shinji Sakamoto, Site 0055
          • Phone Number: +81-86-235-7242
      • Okinawa, Japan, 904-0012
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
      • Osaka, Japan, 590-0018
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
      • Saitama, Japan, 338-8577
        • Recruiting
        • Saitama Neuropsychitric Institute
        • Contact:
          • Hakuei Yamashita, Site 0041
          • Phone Number: 048-857-6811
      • Tokushima, Japan, 770-8503
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Tottori, Japan, 689-0203
        • Withdrawn
        • Local Institution - 0033
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
          • Sohei Kimoto, Site 0006
          • Phone Number: 073-441-0659
      • Yamagata, Japan, 990-0045
        • Recruiting
        • Yamagata Sakuracho Hospital
        • Contact:
          • Nobuhiro Yokokawa, Site 0030
          • Phone Number: +81236312315
    • Aichi-ken
      • Kōnan, Aichi-ken, Japan, 4838248
        • Recruiting
        • Hotei Hospital
        • Contact:
          • Takakura Masashi, Site 0034
          • Phone Number: +81587557251
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University
        • Contact:
          • Taro Kishi, Site 0003
          • Phone Number: +81-562-93-2139
      • Toyoake, Aichi-ken, Japan, 470-1168
        • Recruiting
        • Okehazama Hospital
        • Contact:
          • kiyoshi Fujita, Site 0001
          • Phone Number: 0562971361
    • Chiba
      • Ichikawa, Chiba, Japan, 272-8516
        • Recruiting
        • National Kohnodai Medical Center.
        • Contact:
          • Toshihiko Ito, Site 0009
          • Phone Number: +81-47-372-3501
      • MIdori-ku, Chiba-shi, Chiba, Japan, 266-0007
        • Recruiting
        • National Hospital Organization Shimofusa Psychiatric Medical Center
        • Contact:
          • Teruki Koizumi, Site 0015
          • Phone Number: +81.43.291.1221
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-0014
        • Withdrawn
        • Local Institution - 0032
      • Kitakyushu, Fukuoka, Japan, 803-0831
        • Not yet recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
      • Omuta, Fukuoka, Japan, 836-0004
        • Recruiting
        • Shiranui Hospital
        • Contact:
          • Michihiko Matsushita, Site 0016
          • Phone Number: 81-944-55-2000
    • Fukushima
      • Aizu-Wakamatsu, Fukushima, Japan, 965-0876
        • Recruiting
        • Takeda General Hospital - Aizuwakamatsu
        • Contact:
          • Koichi Osonoe, Site 0042
          • Phone Number: 81242275511
    • Gifu
      • Toki, Gifu, Japan, 509-5142
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0023
        • Recruiting
        • Kure Medical Center
        • Contact:
          • Wataru Omori, Site 0007
          • Phone Number: 0823223111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
          • Naoki Hashimoto, Site 0049
          • Phone Number: 81117067600
      • Sapporo, Hokkaido, Japan, 002-8029
        • Recruiting
        • Goryokai Medical Corporation - Goryokai Hospital
        • Contact:
          • Kimihiro Nakajima, Site 0004
          • Phone Number: +81-11-771-5660
    • Kanagawa
      • Hadano-shi, Kanagawa, Japan, 257-0003
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
      • Hiratsuka, Kanagawa, Japan, 259-1205
        • Recruiting
        • Fujimidai Hospital
        • Contact:
          • Takafumi Yahoko, Site 0040
          • Phone Number: +81-463-58-0186
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital
        • Contact:
          • Ken Inada, Site 0052
          • Phone Number: +81-42-778-8111
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
        • Contact:
          • Nobuhiko Noguchi, Site 0028
          • Phone Number: 81452615656
      • Yokohama, Kanagawa, Japan, 230-0074
        • Recruiting
        • Tsurumi Nishii Hospital
        • Contact:
          • Herbert Nishii, Site 0023
          • Phone Number: 045-581-3055
      • Yokohama, Kanagawa, Japan, 234-0051
        • Recruiting
        • Hino Hospital - Yokohama
        • Contact:
          • Atsuomi Baba, Site 0035
          • Phone Number: +81-45-843-8511
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 861-8002
        • Recruiting
        • Yuge Hospital
        • Contact:
          • Masahiro Shono, Site 0011
          • Phone Number: 81-96-338-3838
      • Yatsushiro, Kumamoto, Japan, 866-0043
        • Withdrawn
        • Local Institution - 0019
    • Kyoto
      • Maizuru, Kyoto, Japan, 625-8502
        • Recruiting
        • National Hospital Organization Maizuru Medical Center
        • Contact:
          • Sumihiro Yamano, Site 0046
          • Phone Number: 81773622680
    • Miyazaki
      • Miyakonojō, Miyazaki, Japan, 885-0093
        • Recruiting
        • Miyakonojo Shinsei Hospital
        • Contact:
          • Masahiko Kawano, Site 0017
          • Phone Number: +81-986-22-0280
    • Nagano
      • Komoro, Nagano, Japan, 384-8540
        • Withdrawn
        • Local Institution - 0014
      • Matsumoto, Nagano, Japan, 390-0847
        • Withdrawn
        • Local Institution - 0050
    • Okinawa
      • Ginowan, Okinawa, Japan, 901-2725
        • Recruiting
        • University of the Ryukyus Hospital
        • Contact:
          • Hotaka Shinzato, Site 0051
          • Phone Number: +8198-894-1301
    • Osaka
      • Hirakata, Osaka, Japan, 573-0022
        • Recruiting
        • Osaka Psychiatric Medical Center
        • Contact:
          • Taro Matsuda, Site 0022
          • Phone Number: 072-847-3261
      • Moriguchi, Osaka, Japan, 570-8507
        • Recruiting
        • Kansai Medical University Medical Center
        • Contact:
          • SHUNICHIRO IKEDA, Site 0026
          • Phone Number: 0669921001
      • Neyagawa, Osaka, Japan, 572-0854
        • Recruiting
        • Nagaokai Medical Corporation - Neyagawa Sanatorium
        • Contact:
          • Naohiko Matsumoto, Site 0021
          • Phone Number: 0728223561
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
          • Tetsufumi Kanazawa, Site 0024
          • Phone Number: 072-683-1221
      • Takatsuki, Osaka, Japan, 569-1041
        • Recruiting
        • Shin-Abuyama Hospital
        • Contact:
          • Hiroki Kikuyama, Site 0005
          • Phone Number: +81726931881
    • Saga-ken
      • Karatsu-shi, Saga-ken, Japan, 847-0031
        • Recruiting
        • Rainbow and Sea Hospital
        • Contact:
          • Taro Shindo, Site 0010
          • Phone Number: 0955770711
      • Tosu, Saga-ken, Japan, 841-0081
        • Recruiting
        • Inuo Hospital
        • Contact:
          • Akifumi Inuo, Site 0038
          • Phone Number: 0942827007
    • Saitama
      • Kumagaya, Saitama, Japan, 360-0114
        • Recruiting
        • Saitama Konan Hospital
        • Contact:
          • Narifumi Yokoyama, Site 0020
          • Phone Number: 048-536-1366
    • Tochigi
      • Shimotsuga, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital
        • Contact:
          • Norio Furukori, Site 0047
          • Phone Number: 0282861111
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Not yet recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
      • Utsunomiya, Tochigi, Japan, 329-1104
        • Not yet recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
    • Tokyo
      • Hachiōji, Tokyo, Japan, 192-0153
        • Withdrawn
        • Local Institution - 0012
      • Kodaira, Tokyo, Japan, 187-8551
        • Recruiting
        • National Center of Neurology and Psychiatry
        • Contact:
          • Kyoji Okita, Site 0002
          • Phone Number: 042-341-2711
      • Machida, Tokyo, Japan, 1940005
        • Recruiting
        • Asuka Hospital
        • Contact:
          • yoshie tamura, Site 0027
          • Phone Number: 042-795-2080
      • Setagaya City, Tokyo, Japan, 1560057
        • Recruiting
        • Tokyo Metropolitan Matsuzawa Hospital
        • Contact:
          • Keiko Genda, Site 0045
          • Phone Number: 0333037211
      • tabashi City, Tokyo, Japan, 175-0091
        • Recruiting
        • Narimasu Kosei Hospital
        • Contact:
          • Yuya Tenjin, Site 0013
          • Phone Number: 0339391191
      • Ōta-ku, Tokyo, Japan, 143-8541
        • Recruiting
        • Toho University Omori Medical Center
        • Contact:
          • Takahiro Nemoto, Site 0053
          • Phone Number: 03-3762-4151
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
          • Fumihiro Higuchi, Site 0036
          • Phone Number: 81836222111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Active Comparator: Administration of KarXT
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time Frame: At week 5
Double-Blind Part
At week 5
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: At Week 52 from OLE baseline
Open-label extension (OLE) Part
At Week 52 from OLE baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in PANSS positive score
Time Frame: At week 5
Double-blind Part
At week 5
Change from baseline in PANSS negative score
Time Frame: At week 5
Double-blind Part
At week 5
Change from baseline in PANSS Negative Marder Factor score
Time Frame: At week 5
Double-blind Part
At week 5
Change from baseline in Clinical Global Impressions-Severity (CGI-S) score
Time Frame: At week 5
Double-blind Part
At week 5
The percentage of PANSS responders (a ≥ 30% change in PANSS total score)
Time Frame: At week 5
Double-blind Part
At week 5
Number of participants wtih adverse events (AEs)
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Number of participants wtih adverse events of special interest (AESIs)
Time Frame: Up to week 57
Up to week 57
Number of participants with procholinergic symptoms
Time Frame: Up to week 57
Up to week 57
Number of participants with anticholinergic symptoms
Time Frame: Up to week 57
Up to week 57
Change from baseline in Simpson-Angus Scale (SAS) score
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Change from baseline in body weight
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Change from baseline in body mass index (BMI)
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Blood pressure (BP) sitting and standing after 2 minutes
Time Frame: Up to week 57
Up to week 57
Heart rate (HR) sitting and standing after 2 minutes
Time Frame: Up to week 57
Up to week 57
Number of participants wtih a change from baseline in hematology evaluations
Time Frame: Up to week 57
Up to week 57
Number of participants wtih a change from baseline in clinical chemistry evaluations
Time Frame: Up to week 57
Up to week 57
Number of participants wtih a change from baseline in coagulation evaluations
Time Frame: Up to week 57
Up to week 57
Number of participants wtih a change from baseline in urinalysis evaluations
Time Frame: Up to week 57
Up to week 57
Number of participants wtih a change from baseline in drug screen evaluations
Time Frame: Up to week 57
Up to week 57
Number of participants wtih a change from baseline in 12-lead electrocardiogram (ECG) evaluations
Time Frame: Up to week 57
Up to week 57
Number of participants wtih physical examination abnormalities
Time Frame: Up to week 57
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
Up to week 57
International Prostate Symptom Score (IPSS)
Time Frame: Up to week 57
Male participants ≥ 45 years of age only
Up to week 57
Area under the plasma concentration-time curve (AUC)
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Maximum observed plasma concentration (Cmax)
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to day 35
Double-blind Part
Up to day 35
Number of participants wtih serious TEAEs
Time Frame: Up to week 57
OLE Part
Up to week 57
Number of participants wtih TEAEs leading to discontinuation of study intervention
Time Frame: Up to week 57
OLE Part
Up to week 57
Change from OLE baseline in PANSS total score
Time Frame: At week 57
OLE Part
At week 57
Change from OLE baseline in CGI-S score
Time Frame: At week 57
OLE Part
At week 57
Percentage of PANSS responders
Time Frame: At week 57
OLE Part
At week 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

September 23, 2028

Study Completion (Estimated)

August 23, 2029

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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