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

NCT06882785 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CN012-0019
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 56

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

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

  Double-Blind Part

  At week 5

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

  Open-label extension (OLE) Part

  At Week 52 from OLE baseline

Secondary Outcomes (33)

• Change from baseline in PANSS positive score

  At week 5

• Change from baseline in PANSS negative score

  At week 5

• Change from baseline in PANSS Negative Marder Factor score

  At week 5

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

  At week 5

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

  At week 5

Study Arms (2)

Administration of KarXT

ACTIVE COMPARATOR

Drug: KarXT

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510

Administration of KarXT

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (56)

Hotei Hospital

Kōnan, Aichi-ken, 4838248, Japan

RECRUITING

Local Institution - 0056

Nagoya, Aichi-ken, 466-8560, Japan

NOT YET RECRUITING

Okehazama Hospital

Toyoake, Aichi-ken, 470-1168, Japan

RECRUITING

Fujita Health University

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

National Kohnodai Medical Center.

Ichikawa, Chiba, 272-8516, Japan

RECRUITING

National Hospital Organization Shimofusa Psychiatric Medical Center

MIdori-ku, Chiba-shi, Chiba, 266-0007, Japan

RECRUITING

Local Institution - 0032

Iizuka, Fukuoka, 820-0014, Japan

WITHDRAWN

Local Institution - 0037

Kitakyushu, Fukuoka, 803-0831, Japan

NOT YET RECRUITING

Shiranui Hospital

Omuta, Fukuoka, 836-0004, Japan

RECRUITING

Takeda General Hospital - Aizuwakamatsu

Aizu-Wakamatsu, Fukushima, 965-0876, Japan

RECRUITING

Local Institution - 0044

Toki, Gifu, 509-5142, Japan

NOT YET RECRUITING

Kure Medical Center

Kure, Hiroshima, 737-0023, Japan

RECRUITING

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, 002-8029, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 0608648, Japan

RECRUITING

Local Institution - 0025

Hadano-shi, Kanagawa, 257-0003, Japan

NOT YET RECRUITING

Fujimidai Hospital

Hiratsuka, Kanagawa, 259-1205, Japan

RECRUITING

Kitasato University Hospital

Sagamihara, Kanagawa, 252-0375, Japan

RECRUITING

Tsurumi Nishii Hospital

Yokohama, Kanagawa, 230-0074, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

RECRUITING

Hino Hospital - Yokohama

Yokohama, Kanagawa, 234-0051, Japan

RECRUITING

Yuge Hospital

Kumamoto, Kumamoto, 861-8002, Japan

RECRUITING

Local Institution - 0019

Yatsushiro, Kumamoto, 866-0043, Japan

WITHDRAWN

National Hospital Organization Maizuru Medical Center

Maizuru, Kyoto, 625-8502, Japan

RECRUITING

Miyakonojo Shinsei Hospital

Miyakonojō, Miyazaki, 885-0093, Japan

RECRUITING

Local Institution - 0014

Komoro, Nagano, 384-8540, Japan

WITHDRAWN

Local Institution - 0050

Matsumoto, Nagano, 390-0847, Japan

WITHDRAWN

University of the Ryukyus Hospital

Ginowan, Okinawa, 901-2725, Japan

RECRUITING

Osaka Psychiatric Medical Center

Hirakata, Osaka, 573-0022, Japan

RECRUITING

Kansai Medical University Medical Center

Moriguchi, Osaka, 570-8507, Japan

RECRUITING

Nagaokai Medical Corporation - Neyagawa Sanatorium

Neyagawa, Osaka, 572-0854, Japan

RECRUITING

Shin-Abuyama Hospital

Takatsuki, Osaka, 569-1041, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, 847-0031, Japan

RECRUITING

Inuo Hospital

Tosu, Saga-ken, 841-0081, Japan

RECRUITING

Saitama Konan Hospital

Kumagaya, Saitama, 360-0114, Japan

RECRUITING

Dokkyo Medical University Hospital

Shimotsuga, Tochigi, 321-0293, Japan

RECRUITING

Local Institution - 0054

Shimotsuke, Tochigi, 329-0498, Japan

NOT YET RECRUITING

Local Institution - 0043

Utsunomiya, Tochigi, 329-1104, Japan

NOT YET RECRUITING

Local Institution - 0012

Hachiōji, Tokyo, 192-0153, Japan

WITHDRAWN

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

RECRUITING

Asuka Hospital

Machida, Tokyo, 1940005, Japan

RECRUITING

Toho University Omori Medical Center

Ōta-ku, Tokyo, 143-8541, Japan

RECRUITING

Tokyo Metropolitan Matsuzawa Hospital

Setagaya City, Tokyo, 1560057, Japan

RECRUITING

Narimasu Kosei Hospital

tabashi City, Tokyo, 175-0091, Japan

RECRUITING

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

RECRUITING

Kuramitsu Hospital

Fukuoka, 819-0037, Japan

RECRUITING

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, 880-8510, Japan

RECRUITING

Okayama University Hospital

Okayama, 700-8558, Japan

RECRUITING

Local Institution - 0018

Okinawa, 904-0012, Japan

NOT YET RECRUITING

Local Institution - 0031

Osaka, 590-0018, Japan

NOT YET RECRUITING

Saitama Neuropsychitric Institute

Saitama, 338-8577, Japan

RECRUITING

Local Institution - 0039

Tokushima, 770-8503, Japan

NOT YET RECRUITING

Local Institution - 0033

Tottori, 689-0203, Japan

WITHDRAWN

Wakayama Medical University Hospital

Wakayama, 641-8510, Japan

RECRUITING

Yamagata Sakuracho Hospital

Yamagata, 990-0045, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 19, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): September 23, 2028
• Study Completion (Estimated): August 23, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (56)