A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia

NCT05919823 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CN012-0063ZL-2701-001
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 28

Brief Summary

A Phase 3, Multicenter, Two-part Study with a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects with DSM-5 Schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 5 of the Double-Blind Period

  PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales: Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210. Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes. Baseline is defined as last non-missing assessment prior to the first dose of study drug.

  At Baseline and at Week 5 of the Double-Blind Period

Secondary Outcomes (24)

• Change From Baseline in Positive Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period

  At Baseline and at Week 5 of the Double-Blind Period

• Change From Baseline in Negative Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period

  At Baseline and at Week 5 of the Double-Blind Period

• Change From Baseline in Negative Marder Factor Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period

  At Baseline and at Week 5 of the Double-Blind Period

• Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score at Week 5 of the Double-Blind Period

  At Baseline and at Week 5 of the Double-Blind Period

• Percentage of PANSS Responders (≥30% Change in PANSS Total Score From Baseline) at Week 5 of the Double-Blind Period

  At Baseline and at Week 5 of the Double-Blind Period

Study Arms (2)

KarXT

EXPERIMENTAL

Drug: Xanomeline and Trospium Chloride Capsules

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Xanomeline and Trospium Chloride Capsules DRUG

Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability.

Also known as: KarXT

KarXT

Placebo DRUG

Placebo Capsules

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:

• Subject is Chinese national, aged 18 to 65 years, inclusive, at screening.
• Subject is capable of providing written informed consent.
• Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI.
• Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
• The subject requires hospitalization for this acute exacerbation or relapse of psychotic symptoms at screen.
• If already an inpatient at screening, hospitalization has to be ≤2 weeks for the current exacerbation at the time of screening.
• PANSS total score between 80 and 120,inclusive, with a scores of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items:
• Item 1 (P1; delusions)
• Item 2 (P2; conceptual disorganization)
• Item 3 (P3; hallucinatory behavior)
• Item 6 (P6; suspiciousness/persecution)
• Subjects with no change (improvement) in PANSS total score between screening and baseline (Day -1) of more than 20%.
• Subject has a CGI-S score of ≥4 at screening and baseline (Day -1) visits.
• Subject will have been off lithium therapy for at least 2 weeks before baseline and free of all oral antipsychotic medications for at least 5 half-lives or 1 week, whichever is longer, before baseline (Day -1).
• Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline visit (Day -1).

You may not qualify if:

• Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening).
• Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
• Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
• History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
• History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
• Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS.
• Clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results at screening that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
• Subjects are receiving or have recently received (within 5 half-lives or 1 week, whichever is longer, before baseline \[Day -1\]) oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (e.g., lamotrigine, valproate); tricyclic antidepressants (e.g., imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam, chloral hydrate).
• Subjects are receiving or have recently received (within 1 week before baseline \[Day -1\]) metformin.
• Pregnant, lactating, or less than 3 months postpartum.
• In the opinion of the investigator and/or Sponsor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator and/or Sponsor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
• Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
• Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or has required clozapine within the last 12 months.
• Subjects with prior exposure to KarXT.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: collaborator
• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (28)

Anhui Mental Health Center

Hefei, Anhui, 230022, China

Location

Wuhu Hospital of Beijing Anding Hospital

Wuhu, Anhui, 241000, China

Location

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, 100035, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100083, China

Location

Beijing HuiLongGuan Hospital

Changping, Beijing Municipality, 100096, China

Location

Chongqing 11th People's Hospital

Chongqing, Chongqing Municipality, 400047, China

Location

Chongqing Mental Health Center

Jiangbei, Chongqing Municipality, 401147, China

Location

The Affiliated Brain Hospital of Guangzhou Medical University

Guanzhou, Guangdong, 510370, China

Location

The Sixth People's Hosptial of Hebei Province

Baoding, Hebei, 071051, China

Location

Daqing City Third Hospital

Daqing, Heilongjiang, 163161, China

Location

Zhumadian Second People's Hospital

Zhumadian, Henan, 463001, China

Location

Wuhan Mental Health Center

Wuhan, Hubei, 430000, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430064, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Wuxi Mental Health Center

Wuxi, Jiangsu, 214151, China

Location

Jiangxi Mental Health Center

Nanchang, Jiangxi, 330027, China

Location

Mental Health Center of Xi'an City

Xi'an, Shaanxi, 710061, China

Location

Shandong Mental Health Center

Jinan, Shandong, 250014, China

Location

Shandong Daizhuang Hospital

Jining, Shandong, 272009, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200032, China

Location

The Fourth People's Hospital of Chengdu

Chengdu, Sichuan, 610036, China

Location

Guangyuan Mental Health Center

Guangyuan, Sichuan, 628033, China

Location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300382, China

Location

Urumqi Fourth People's Hospital

Ürümqi, Xinjiang, 830002, China

Location

Hangzhou Seventh People's Hospital

Hangzhou, Zhejiang, 310013, China

Location

HuZhou Third Municipal Hospital

Huzhou, Zhejiang, 313028, China

Location

Ningbo Kangning Hospital

Ningbo, Zhejiang, 315002, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325015, China

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

1-855-907-3286

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: May 29, 2023
• Primary Completion: September 16, 2024
• Study Completion: December 9, 2024
• Last Updated: December 17, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-12

Locations

CN (28)