Clinical trial NCT06572449: Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
Official title: A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: BMS-986510
KarXT
DSM-5 Schizophrenia
Diagnostic and Statistical Manual of Mental Disorders
Mental Disorders
Lead sponsor: Karuna Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
* Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
* Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
* Willing and able to discontinue all antipsychotic medications prior to baseline visit.

Exclusion Criteria:

* History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
* Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
* History of treatment resistance to schizophrenia medications.
* History of allergy/hypersensitivity to KarXT.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 11 weeks
Secondary outcomes:
measure: Incidence of TEAEs by study period
timeFrame: Up to approximately 11 weeks
measure: Incidence of serious TEAEs
timeFrame: Up to approximately 11 weeks
measure: Incidence of serious TEAEs by study period
timeFrame: Up to approximately 11 weeks
measure: Incidence of TEAEs leading to study intervention discontinuation
timeFrame: Up to approximately 11 weeks
measure: Incidence of TEAEs leading to study intervention discontinuation by study period
timeFrame: Up to approximately 11 weeks
measure: Incidence of pro- and anticholinergic TEAEs
timeFrame: Up to approximately 11 weeks
measure: Incidence of pro- and anticholinergic TEAEs by study period
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in PANSS positive score
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in PANSS negative score
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in PANSS negative Marder Factor score
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in Clinical Global Impression-Severity (CGI-S) score
timeFrame: Up to approximately 11 weeks
measure: Spontaneously reported adverse event of special interest (AESIs)
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in body weight
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in body mass index (BMI)
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in waist circumference
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in orthostatic vital signs (supine and standing after 2 minutes) at Day 7 and Day 14: blood pressure (systolic and diastolic) and heart rate
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in blood pressure
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in heart rate
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in clinical laboratory assessment (Hematology)
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in clinical laboratory assessment (Clinical chemistry)
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in clinical laboratory assessment (Urinalysis)
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in clinical laboratory assessment (Drug screen)
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in 12-lead ECG [Ventricular rate (bpm)]
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in 12-lead ECG [PR interval (msec)]
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in 12-lead ECG [QRS interval (msec)]
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in 12-lead ECG [QT interval (msec)]
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in 12-lead ECG [QTcF interval (msec)]
timeFrame: Up to approximately 11 weeks
measure: Change from baseline in physical examination
timeFrame: Up to approximately 11 weeks
measure: Suicidal ideation scale with the use of Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to approximately 11 weeks
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Local Institution - 0002
state: California
city: Riverside
country: United States
facility: Local Institution - 0004
state: California
city: Hollywood
country: United States
facility: Local Institution - 0006
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0005
state: Georgia
city: Decatur
country: United States
facility: Local Institution - 0003
state: Georgia
city: Marlton
country: United States
facility: Local Institution - 0001
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: