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

Phase 3

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: KarXT; Other: Placebo

• Registration Number: NCT06882785
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Start: 2025-05-30
• Primary Completion: 2028-09-23
• Study Completion: 2029-08-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of KarXT	KarXT	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (47)

Local Institution - 0033; 🇯🇵 Tottori, Japan

Local Institution - 0006; 🇯🇵 Wakayama, Japan

Local Institution - 0030; 🇯🇵 Yamagata, Japan

Local Institution - 0025; 🇯🇵 Hadano-shi, Kanagawa, Japan

Local Institution - 0040; 🇯🇵 Hiratsuka, Kanagawa, Japan

Local Institution - 0023; 🇯🇵 Yokohama, Kanagawa, Japan

Local Institution - 0028; 🇯🇵 Yokohama, Kanagawa, Japan

Local Institution - 0035; 🇯🇵 Yokohama, Kanagawa, Japan

Local Institution - 0034; 🇯🇵 Konan, Aichi, Japan

Local Institution - 0001; 🇯🇵 Toyoake, Aichi, Japan

Local Institution - 0003; 🇯🇵 Toyoake, Aichi, Japan

Local Institution - 0009; 🇯🇵 Ichikawa, Chiba, Japan

Local Institution - 0015; 🇯🇵 MIdori-ku, Chiba-shi, Chiba, Japan

Local Institution - 0032; 🇯🇵 Iizuka-city, Fukuoka, Japan

Local Institution - 0037; 🇯🇵 Kitakyushu, Fukuoka, Japan

Local Institution - 0016; 🇯🇵 Omuta, Fukuoka, Japan

Local Institution - 0042; 🇯🇵 Aizuwakamatsu, Fukushima, Japan

Local Institution - 0044; 🇯🇵 Toki, Gifu, Japan

Local Institution - 0007; 🇯🇵 Kure, Hiroshima, Japan

Local Institution - 0004; 🇯🇵 Sapporo, Hokkaido, Japan

Local Institution - 0011; 🇯🇵 Kumamoto-City, Kumamoto, Japan

Local Institution - 0019; 🇯🇵 Yatsushiro, Kumamoto, Japan

Local Institution - 0046; 🇯🇵 Maizuru, Kyoto, Japan

Local Institution - 0017; 🇯🇵 Miyakonojo, Miyazaki, Japan

Local Institution - 0014; 🇯🇵 Komoro, Nagano, Japan

Local Institution - 0022; 🇯🇵 Hirakata, Osaka, Japan

Local Institution - 0026; 🇯🇵 Moriguchi, Osaka, Japan

Local Institution - 0021; 🇯🇵 Neyagawa, Osaka, Japan

Local Institution - 0005; 🇯🇵 Takatsuki, Osaka, Japan

Local Institution - 0024; 🇯🇵 Takatsuki, Osaka, Japan

Local Institution - 0010; 🇯🇵 Karatsu-shi, Saga-Ken, Japan

Local Institution - 0038; 🇯🇵 Tosu, Saga, Japan

Local Institution - 0020; 🇯🇵 Kumagaya, Saitama, Japan

Local Institution - 0047; 🇯🇵 Shimotsuga, Tochigi, Japan

Local Institution - 0043; 🇯🇵 Utsunomiya, Tochigi, Japan

Local Institution - 0012; 🇯🇵 Hachioji, Tokyo, Japan

Local Institution - 0013; 🇯🇵 Itabashi City, Tokyo, Japan

Local Institution - 0002; 🇯🇵 Kodaira, Tokyo, Japan

Local Institution - 0027; 🇯🇵 Machida, Tokyo, Japan

Local Institution - 0045; 🇯🇵 Setagaya, Tokyo, Japan

Local Institution - 0036; 🇯🇵 Ube, Yamaguchi, Japan

Local Institution - 0008; 🇯🇵 Fukuoka, Japan

Local Institution - 0029; 🇯🇵 Miyazaki, Japan

Local Institution - 0018; 🇯🇵 Okinawa, Japan

Local Institution - 0031; 🇯🇵 Osaka, Japan

Local Institution - 0041; 🇯🇵 Saitama, Japan

Local Institution - 0039; 🇯🇵 Tokushima, Japan