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RecruitingPhase 3NCT06882785

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

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

Sponsor

Bristol-Myers Squibb

Enrollment

250 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

Interventions

DRUGKarXT

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Locations(55)

Hotei Hospital

Kōnan, Aichi-ken, Japan

Local Institution - 0056

Nagoya, Aichi-ken, Japan

Okehazama Hospital

Toyoake, Aichi-ken, Japan

Fujita Health University

Toyoake, Aichi-ken, Japan

National Kohnodai Medical Center.

Ichikawa, Chiba, Japan

National Hospital Organization Shimofusa Psychiatric Medical Center

MIdori-ku, Chiba-shi, Chiba, Japan

Local Institution - 0032

Iizuka, Fukuoka, Japan

Local Institution - 0037

Kitakyushu, Fukuoka, Japan

Shiranui Hospital

Omuta, Fukuoka, Japan

Takeda General Hospital - Aizuwakamatsu

Aizu-Wakamatsu, Fukushima, Japan

Local Institution - 0044

Toki, Gifu, Japan

Kure Medical Center

Kure, Hiroshima, Japan

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Local Institution - 0025

Hadano-shi, Kanagawa, Japan

Fujimidai Hospital

Hiratsuka, Kanagawa, Japan

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Tsurumi Nishii Hospital

Yokohama, Kanagawa, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Hino Hospital - Yokohama

Yokohama, Kanagawa, Japan

Yuge Hospital

Kumamoto, Kumamoto, Japan

Local Institution - 0019

Yatsushiro, Kumamoto, Japan

National Hospital Organization Maizuru Medical Center

Maizuru, Kyoto, Japan

Miyakonojo Shinsei Hospital

Miyakonojō, Miyazaki, Japan

Local Institution - 0014

Komoro, Nagano, Japan

Local Institution - 0050

Matsumoto, Nagano, Japan

University of the Ryukyus Hospital

Ginowan, Okinawa, Japan

Osaka Psychiatric Medical Center

Hirakata, Osaka, Japan

Kansai Medical University Medical Center

Moriguchi, Osaka, Japan

Nagaokai Medical Corporation - Neyagawa Sanatorium

Neyagawa, Osaka, Japan

Shin-Abuyama Hospital

Takatsuki, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, Japan

Inuo Hospital

Tosu, Saga-ken, Japan

Saitama Konan Hospital

Kumagaya, Saitama, Japan

Dokkyo Medical University Hospital

Shimotsuga, Tochigi, Japan

Local Institution - 0043

Utsunomiya, Tochigi, Japan

Local Institution - 0012

Hachiōji, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Asuka Hospital

Machida, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Tokyo Metropolitan Matsuzawa Hospital

Setagaya City, Tokyo, Japan

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Kuramitsu Hospital

Fukuoka, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Japan

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Japan

Local Institution - 0055

Okayama, Japan

Local Institution - 0018

Okinawa, Japan

Local Institution - 0031

Osaka, Japan

Saitama Neuropsychitric Institute

Saitama, Japan

Local Institution - 0039

Tokushima, Japan

Local Institution - 0033

Tottori, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Yamagata Sakuracho Hospital

Yamagata, Japan

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NCT06882785

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