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

Phase 3RecruitingNCT06882785

Bristol-Myers Squibb250 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

250

Conditions

Schizophrenia

Interventions

KarXTDRUG

Specified dose on specified days

PlaceboOTHER

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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 Criteria * 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.

Locations (55)

Outcomes

Primary Outcomes

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

Double-Blind Part

Time frame: At week 5

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

Open-label extension (OLE) Part

Time frame: At Week 52 from OLE baseline

Secondary Outcomes

Change from baseline in PANSS positive score

Double-blind Part

Time frame: At week 5

Change from baseline in PANSS negative score

Double-blind Part

Time frame: At week 5

Change from baseline in PANSS Negative Marder Factor score

Double-blind Part

Time frame: At week 5

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

Double-blind Part

Time frame: At week 5

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

Double-blind Part

Time frame: At week 5

Number of participants wtih adverse events (AEs)

Double-blind Part

Time frame: Up to day 35

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

Time frame: Up to week 57

Central 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

Data from ClinicalTrials.gov

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Hotei Hospital

Kōnan, Aichi-ken, Japan

RECRUITING

Local Institution - 0056

Nagoya, Aichi-ken, Japan

NOT_YET_RECRUITING

Okehazama Hospital

Toyoake, Aichi-ken, Japan

RECRUITING

Fujita Health University

Toyoake, Aichi-ken, Japan

RECRUITING

National Kohnodai Medical Center.

Ichikawa, Chiba, Japan

RECRUITING

National Hospital Organization Shimofusa Psychiatric Medical Center

MIdori-ku, Chiba-shi, Chiba, Japan

RECRUITING

Local Institution - 0032

Iizuka, Fukuoka, Japan

WITHDRAWN

Local Institution - 0037

Kitakyushu, Fukuoka, Japan

NOT_YET_RECRUITING

Shiranui Hospital

Omuta, Fukuoka, Japan

RECRUITING

Takeda General Hospital - Aizuwakamatsu

Aizu-Wakamatsu, Fukushima, Japan

RECRUITING

...and 45 more locations

Number of participants with procholinergic symptoms

Time frame: Up to week 57

Number of participants with anticholinergic symptoms

Time frame: Up to week 57

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

Double-blind Part

Time frame: Up to day 35

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

Double-blind Part

Time frame: Up to day 35

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

Double-blind Part

Time frame: Up to day 35

Change from baseline in body weight

Double-blind Part

Time frame: Up to day 35

Change from baseline in body mass index (BMI)

Double-blind Part

Time frame: Up to day 35

Blood pressure (BP) sitting and standing after 2 minutes

Time frame: Up to week 57

Heart rate (HR) sitting and standing after 2 minutes

Time frame: Up to week 57

Number of participants wtih a change from baseline in hematology evaluations

Time frame: Up to week 57

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

Time frame: Up to week 57

Number of participants wtih a change from baseline in coagulation evaluations

Time frame: Up to week 57

Number of participants wtih a change from baseline in urinalysis evaluations

Time frame: Up to week 57

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

Time frame: Up to week 57

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

Time frame: Up to week 57

Number of participants wtih physical examination abnormalities

Time frame: Up to week 57

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

Time frame: Up to week 57

International Prostate Symptom Score (IPSS)

Male participants ≥ 45 years of age only

Time frame: Up to week 57

Area under the plasma concentration-time curve (AUC)

Double-blind Part

Time frame: Up to day 35

Maximum observed plasma concentration (Cmax)

Double-blind Part

Time frame: Up to day 35

Time of maximum observed plasma concentration (Tmax)

Double-blind Part

Time frame: Up to day 35

Number of participants wtih serious TEAEs

OLE Part

Time frame: Up to week 57

Number of participants wtih TEAEs leading to discontinuation of study intervention

OLE Part

Time frame: Up to week 57

Change from OLE baseline in PANSS total score

OLE Part

Time frame: At week 57

Change from OLE baseline in CGI-S score

OLE Part

Time frame: At week 57

Percentage of PANSS responders

OLE Part

Time frame: At week 57