AzTrials
AzTrials

SchizophreniaPhase 3NCT06882785

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

A Phase 3 study testing KarXT in people with Schizophrenia, run by Bristol-Myers Squibb at 56 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
KarXT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
56 sitesJapan
Study dates
10 Jun 2025to 23 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

56 sites in 1 country. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

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

56 sites in 1 country

Japan56 sites, 50 recruiting

  • Takeda General Hospital - Aizuwakamatsu

    Aizu-Wakamatsu, Fukushima, 965-0876

    Koichi Osonoe, Site 0042, 81242275511

    Recruiting

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    Chiba, 266-0007

    Teruki Koizumi, Site 0015, +81.43.291.1221

    Recruiting

  • Kuramitsu Hospital

    Fukuoka, 819-0037

    Noriko Tamaru, Site 0008, +81-92-811-1821

    Recruiting

  • University of the Ryukyus Hospital

    Ginowan, Okinawa, 901-2725

    Hotaka Shinzato, Site 0051, +8198-894-1301

    Recruiting

  • Local Institution - 0012

    Hachiōji, Tokyo, 192-0153

    Withdrawn

  • Local Institution - 0025

    Hadano-shi, Kanagawa, 257-0003

    Site 0025

    Not yet recruiting

  • Osaka Psychiatric Medical Center

    Hirakata, Osaka, 573-0022

    Taro Matsuda, Site 0022, 072-847-3261

    Recruiting

  • Fujimidai Hospital

    Hiratsuka, Kanagawa, 259-1205

    Takafumi Yahoko, Site 0040, +81-463-58-0186

    Recruiting

  • National Kohnodai Medical Center.

    Ichikawa, Chiba, 272-8516

    Toshihiko Ito, Site 0009, +81-47-372-3501

    Recruiting

  • Local Institution - 0032

    Iizuka, Fukuoka, 820-0014

    Withdrawn

  • Rainbow and Sea Hospital

    Karatsu-shi, Saga-ken, 847-0031

    Taro Shindo, Site 0010, 0955770711

    Recruiting

  • Local Institution - 0037

    Kitakyushu, Fukuoka, 803-0831

    Site 0037

    Not yet recruiting

  • National Center of Neurology and Psychiatry

    Kodaira, Tokyo, 187-8551

    Kyoji Okita, Site 0002, 042-341-2711

    Recruiting

  • Local Institution - 0014

    Komoro, Nagano, 384-8540

    Withdrawn

  • Hotei Hospital

    Kōnan, Aichi-ken, 4838248

    Takakura Masashi, Site 0034, +81587557251

    Recruiting

  • Saitama Konan Hospital

    Kumagaya, Saitama, 360-0114

    Narifumi Yokoyama, Site 0020, 048-536-1366

    Recruiting

  • Yuge Hospital

    Kumamoto, Kumamoto, 861-8002

    Masahiro Shono, Site 0011, 81-96-338-3838

    Recruiting

  • Kure Medical Center

    Kure, Hiroshima, 737-0023

    Wataru Omori, Site 0007, 0823223111

    Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

    Anri WATANABE, Site 0048, +81-752515612

    Recruiting

  • Asuka Hospital

    Machida, Tokyo, 1940005

    yoshie tamura, Site 0027, 042-795-2080

    Recruiting

  • National Hospital Organization Maizuru Medical Center

    Maizuru, Kyoto, 625-8502

    Sumihiro Yamano, Site 0046, 81773622680

    Recruiting

  • Local Institution - 0050

    Matsumoto, Nagano, 390-0847

    Withdrawn

  • Miyakonojo Shinsei Hospital

    Miyakonojō, Miyazaki, 885-0093

    Masahiko Kawano, Site 0017, +81-986-22-0280

    Recruiting

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki, 880-8510

    Jiro Kawano, Site 0029, 81985244181

    Recruiting

  • Kansai Medical University Medical Center

    Moriguchi, Osaka, 570-8507

    SHUNICHIRO IKEDA, Site 0026, 0669921001

    Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

    Hiroshige Fujishiro, Site 0056, 0527442282

    Recruiting

  • Nagaokai Medical Corporation - Neyagawa Sanatorium

    Neyagawa, Osaka, 572-0854

    Naohiko Matsumoto, Site 0021, 0728223561

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Shinji Sakamoto, Site 0055, +81-86-235-7242

    Recruiting

  • Local Institution - 0018

    Okinawa, 904-0012

    Site 0018

    Not yet recruiting

  • Shiranui Hospital

    Omuta, Fukuoka, 836-0004

    Michihiko Matsushita, Site 0016, 81-944-55-2000

    Recruiting

  • Asakayama Hospital

    Osaka, 590-0018

    Norio Taniguchi, Site 0031, +81-72-229-4882

    Recruiting

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo, 143-8541

    Takahiro Nemoto, Site 0053, 03-3762-4151

    Recruiting

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

    Ken Inada, Site 0052, +81-42-778-8111

    Recruiting

  • Saitama Neuropsychitric Institute

    Saitama, 338-8577

    Hakuei Yamashita, Site 0041, 048-857-6811

    Recruiting

  • Goryokai Medical Corporation - Goryokai Hospital

    Sapporo, Hokkaido, 002-8029

    Kimihiro Nakajima, Site 0004, +81-11-771-5660

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 0608648

    Naoki Hashimoto, Site 0049, 81117067600

    Recruiting

  • Tokyo Metropolitan Matsuzawa Hospital

    Setagaya City, Tokyo, 1560057

    Keiko Genda, Site 0045, 0333037211

    Recruiting

  • Dokkyo Medical University Hospital

    Shimotsuga, Tochigi, 321-0293

    Norio Furukori, Site 0047, 0282861111

    Recruiting

  • Local Institution - 0054

    Shimotsuke, Tochigi, 329-0498

    Site 0054

    Not yet recruiting

  • Narimasu Kosei Hospital

    tabashi City, Tokyo, 175-0091

    Yuya Tenjin, Site 0013, 0339391191

    Recruiting

  • Shin-Abuyama Hospital

    Takatsuki, Osaka, 569-1041

    Hiroki Kikuyama, Site 0005, +81726931881

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, 569-8686

    Tetsufumi Kanazawa, Site 0024, 072-683-1221

    Recruiting

  • Holy Cross Hospital - Toki

    Toki, Gifu, 509-5142

    Hideaki Tabuse, Site 0044, 0572-54-8181

    Recruiting

  • Tokushima University Hospital

    Tokushima, 770-8503

    Tomohiko Nakayama, Site 0039, 088-631-7130

    Recruiting

  • Inuo Hospital

    Tosu, Saga-ken, 841-0081

    Akifumi Inuo, Site 0038, 0942827007

    Recruiting

  • Local Institution - 0033

    Tottori, 689-0203

    Withdrawn

  • Okehazama Hospital

    Toyoake, Aichi-ken, 470-1168

    kiyoshi Fujita, Site 0001, 0562971361

    Recruiting

  • Fujita Health University

    Toyoake, Aichi-ken, 470-1192

    Taro Kishi, Site 0003, +81-562-93-2139

    Recruiting

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

    Fumihiro Higuchi, Site 0036, 81836222111

    Recruiting

  • Tochigi Prefectural Okamotodai Hospital

    Utsunomiya, Tochigi, 3291104

    Taku Amano, Site 0043, 81-28-673-2211

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

    Sohei Kimoto, Site 0006, 073-441-0659

    Recruiting

  • Yamagata Sakuracho Hospital

    Yamagata, 990-0045

    Nobuhiro Yokokawa, Site 0030, +81236312315

    Recruiting

  • Local Institution - 0019

    Yatsushiro, Kumamoto, 866-0043

    Withdrawn

  • Tsurumi Nishii Hospital

    Yokohama, Kanagawa, 230-0074

    Herbert Nishii, Site 0023, 045-581-3055

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

    Nobuhiko Noguchi, Site 0028, 81452615656

    Recruiting

  • Hino Hospital - Yokohama

    Yokohama, Kanagawa, 234-0051

    Atsuomi Baba, Site 0035, +81-45-843-8511

    Recruiting

Other trials in Japan

About this study

Official 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

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

Conditions
Schizophrenia
Being tested
KarXT, Placebo
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KarXTDrug

    Also called BMS-986510

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT06882785
Study groupRoleWhat they receive
Administration of KarXTActive comparatorNot described
Receives: Drug: KarXT
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Double-Blind Part

    Measured: At week 5

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

    Open-label extension (OLE) Part

    Measured: At Week 52 from OLE baseline

Secondary outcomes (33)

  1. Change from baseline in PANSS positive score

    Double-blind Part

    Measured: At week 5

  2. Change from baseline in PANSS negative score

    Double-blind Part

    Measured: At week 5

  3. Change from baseline in PANSS Negative Marder Factor score

    Double-blind Part

    Measured: At week 5

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

    Double-blind Part

    Measured: At week 5

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

    Double-blind Part

    Measured: At week 5

  6. Number of participants wtih adverse events (AEs)

    Double-blind Part

    Measured: Up to day 35

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

    Measured: Up to week 57

  8. Number of participants with procholinergic symptoms

    Measured: Up to week 57

  9. Number of participants with anticholinergic symptoms

    Measured: Up to week 57

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

    Double-blind Part

    Measured: Up to day 35

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

    Double-blind Part

    Measured: Up to day 35

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

    Double-blind Part

    Measured: Up to day 35

  13. Change from baseline in body weight

    Double-blind Part

    Measured: Up to day 35

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

    Double-blind Part

    Measured: Up to day 35

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

    Measured: Up to week 57

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

    Measured: Up to week 57

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

    Measured: Up to week 57

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

    Measured: Up to week 57

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

    Measured: Up to week 57

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

    Measured: Up to week 57

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

    Measured: Up to week 57

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

    Measured: Up to week 57

  23. Number of participants wtih physical examination abnormalities

    Measured: Up to week 57

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

    Measured: Up to week 57

  25. International Prostate Symptom Score (IPSS)

    Male participants ≥ 45 years of age only

    Measured: Up to week 57

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

    Double-blind Part

    Measured: Up to day 35

  27. Maximum observed plasma concentration (Cmax)

    Double-blind Part

    Measured: Up to day 35

  28. Time of maximum observed plasma concentration (Tmax)

    Double-blind Part

    Measured: Up to day 35

  29. Number of participants wtih serious TEAEs

    OLE Part

    Measured: Up to week 57

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

    OLE Part

    Measured: Up to week 57

  31. Change from OLE baseline in PANSS total score

    OLE Part

    Measured: At week 57

  32. Change from OLE baseline in CGI-S score

    OLE Part

    Measured: At week 57

  33. Percentage of PANSS responders

    OLE Part

    Measured: At week 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start10 Jun 2025
  3. Primary completion23 Sep 2028 (estimated)
  4. Study completion23 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06882785
Sponsor's protocol ID
CN012-0019
Status last verified
Oct 2026
First submitted
17 Mar 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KarXT in people with Schizophrenia, run by Bristol-Myers Squibb at 56 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (time frame: At week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06882785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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