Clinical trial NCT06882785: A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: At week 5
measure: Number of participants wtih treatment-emergent adverse events (TEAEs)
timeFrame: At Week 52 from OLE baseline
Secondary outcomes:
measure: Change from baseline in PANSS positive score
timeFrame: At week 5
measure: Change from baseline in PANSS negative score
timeFrame: At week 5
measure: Change from baseline in PANSS Negative Marder Factor score
timeFrame: At week 5
measure: Change from baseline in Clinical Global Impressions-Severity (CGI-S) score
timeFrame: At week 5
measure: The percentage of PANSS responders (a ≥ 30% change in PANSS total score)
timeFrame: At week 5
measure: Number of participants wtih adverse events (AEs)
timeFrame: Up to day 35
measure: Number of participants wtih adverse events of special interest (AESIs)
timeFrame: Up to week 57
measure: Number of participants with procholinergic symptoms
timeFrame: Up to week 57
measure: Number of participants with anticholinergic symptoms
timeFrame: Up to week 57
measure: Change from baseline in Simpson-Angus Scale (SAS) score
timeFrame: Up to day 35
measure: Change from baseline in Barnes Akathisia Rating Scale (BARS) score
timeFrame: Up to day 35
measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
timeFrame: Up to day 35
measure: Change from baseline in body weight
timeFrame: Up to day 35
measure: Change from baseline in body mass index (BMI)
timeFrame: Up to day 35
measure: Blood pressure (BP) sitting and standing after 2 minutes
timeFrame: Up to week 57
measure: Heart rate (HR) sitting and standing after 2 minutes
timeFrame: Up to week 57
measure: Number of participants wtih a change from baseline in hematology evaluations
timeFrame: Up to week 57
measure: Number of participants wtih a change from baseline in clinical chemistry evaluations
timeFrame: Up to week 57
measure: Number of participants wtih a change from baseline in coagulation evaluations
timeFrame: Up to week 57
measure: Number of participants wtih a change from baseline in urinalysis evaluations
timeFrame: Up to week 57
measure: Number of participants wtih a change from baseline in drug screen evaluations
timeFrame: Up to week 57
measure: Number of participants wtih a change from baseline in 12-lead electrocardiogram (ECG) evaluations
timeFrame: Up to week 57
measure: Number of participants wtih physical examination abnormalities
timeFrame: Up to week 57
measure: Number of participants wtih suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to week 57
measure: International Prostate Symptom Score (IPSS)
timeFrame: Up to week 57
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to day 35
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to day 35
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to day 35
measure: Number of participants wtih serious TEAEs
timeFrame: Up to week 57
measure: Number of participants wtih TEAEs leading to discontinuation of study intervention
timeFrame: Up to week 57
measure: Change from OLE baseline in PANSS total score
timeFrame: At week 57
measure: Change from OLE baseline in CGI-S score
timeFrame: At week 57
measure: Percentage of PANSS responders
timeFrame: At week 57
Other outcomes:
Locations:
city: Konan
country: Japan
facility: Local Institution - 0034
state: Aichi
city: Toyoake
country: Japan
facility: Local Institution - 0001
state: Aichi
city: Toyoake
country: Japan
facility: Local Institution - 0003
state: Aichi
city: Ichikawa
country: Japan
facility: Local Institution - 0009
state: Chiba
city: MIdori-ku, Chiba-shi
country: Japan
facility: Local Institution - 0015
state: Chiba
city: Iizuka-city
country: Japan
facility: Local Institution - 0032
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Local Institution - 0037
state: Fukuoka
city: Omuta
country: Japan
facility: Local Institution - 0016
state: Fukuoka
city: Aizuwakamatsu
country: Japan
facility: Local Institution - 0042
state: Fukushima
city: Toki
country: Japan
facility: Local Institution - 0044
state: Gifu
city: Kure
country: Japan
facility: Local Institution - 0007
state: Hiroshima
city: Sapporo
country: Japan
facility: Local Institution - 0004
state: Hokkaido
city: Hadano-shi
country: Japan
facility: Local Institution - 0025
state: Kanagawa
city: Hiratsuka
country: Japan
facility: Local Institution - 0040
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution - 0023
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution - 0028
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution - 0035
state: Kanagawa
city: Kumamoto-City
country: Japan
facility: Local Institution - 0011
state: Kumamoto
city: Yatsushiro
country: Japan
facility: Local Institution - 0019
state: Kumamoto
city: Maizuru
country: Japan
facility: Local Institution - 0046
state: Kyoto
city: Miyakonojo
country: Japan
facility: Local Institution - 0017
state: Miyazaki
city: Komoro
country: Japan
facility: Local Institution - 0014
state: Nagano
city: Hirakata
country: Japan
facility: Local Institution - 0022
state: Osaka
city: Moriguchi
country: Japan
facility: Local Institution - 0026
state: Osaka
city: Neyagawa
country: Japan
facility: Local Institution - 0021
state: Osaka
city: Takatsuki
country: Japan
facility: Local Institution - 0005
state: Osaka
city: Takatsuki
country: Japan
facility: Local Institution - 0024
state: Osaka
city: Karatsu-shi
country: Japan
facility: Local Institution - 0010
state: Saga-Ken
city: Tosu
country: Japan
facility: Local Institution - 0038
state: Saga
city: Kumagaya
country: Japan
facility: Local Institution - 0020
state: Saitama
city: Shimotsuga
country: Japan
facility: Local Institution - 0047
state: Tochigi
city: Utsunomiya
country: Japan
facility: Local Institution - 0043
state: Tochigi
city: Hachioji
country: Japan
facility: Local Institution - 0012
state: Tokyo
city: Itabashi City
country: Japan
facility: Local Institution - 0013
state: Tokyo
city: Kodaira
country: Japan
facility: Local Institution - 0002
state: Tokyo
city: Machida
country: Japan
facility: Local Institution - 0027
state: Tokyo
city: Setagaya
country: Japan
facility: Local Institution - 0045
state: Tokyo
city: Ube
country: Japan
facility: Local Institution - 0036
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Local Institution - 0008
city: Miyazaki
country: Japan
facility: Local Institution - 0029
city: Okinawa
country: Japan
facility: Local Institution - 0018
city: Osaka
country: Japan
facility: Local Institution - 0031
city: Saitama
country: Japan
facility: Local Institution - 0041
city: Tokushima
country: Japan
facility: Local Institution - 0039
city: Tottori
country: Japan
facility: Local Institution - 0033
city: Wakayama
country: Japan
facility: Local Institution - 0006
city: Yamagata
country: Japan
facility: Local Institution - 0030
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: