Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: KarXT

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Alamitos, California, United States, 90720-3118
      • Local Institution - 0002
    • Riverside, California, United States, 92506-3257
      • Local Institution - 0004
  • Florida
    • Hollywood, Florida, United States, 33024
      • Local Institution - 0006
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Local Institution - 0005
    • Decatur, Georgia, United States, 30030
      • Local Institution - 0003
  • New Jersey
    • Marlton, New Jersey, United States, 08053-3449
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KarXT on empty stomach and with food	Drug: KarXT; Specified dose on specified days; Other Names: BMS-986510

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Up to approximately 11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of TEAEs by study period		Up to approximately 11 weeks
Incidence of serious TEAEs		Up to approximately 11 weeks
Incidence of serious TEAEs by study period		Up to approximately 11 weeks
Incidence of TEAEs leading to study intervention discontinuation		Up to approximately 11 weeks
Incidence of TEAEs leading to study intervention discontinuation by study period		Up to approximately 11 weeks
Incidence of pro- and anticholinergic TEAEs		Up to approximately 11 weeks
Incidence of pro- and anticholinergic TEAEs by study period		Up to approximately 11 weeks
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score		Up to approximately 11 weeks
Change from baseline in PANSS positive score		Up to approximately 11 weeks
Change from baseline in PANSS negative score		Up to approximately 11 weeks
Change from baseline in PANSS negative Marder Factor score		Up to approximately 11 weeks
Change from baseline in Clinical Global Impression-Severity (CGI-S) score		Up to approximately 11 weeks
Spontaneously reported adverse event of special interest (AESIs)		Up to approximately 11 weeks
Change from baseline in body weight		Up to approximately 11 weeks
Change from baseline in body mass index (BMI)		Up to approximately 11 weeks
Change from baseline in waist circumference		Up to approximately 11 weeks
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	BP includes systolic and diastolic measurements (mm Hg); Heart rate is measured in beats/minute (bpm)	Up to approximately 11 weeks
Change from baseline in blood pressure		Up to approximately 11 weeks
Change from baseline in heart rate		Up to approximately 11 weeks
Change from baseline in clinical laboratory assessment (Hematology)	Hematology will include full, differential blood [red blood cell (RBC), white blood cell (WBC)] and platelet counts, hemoglobin, hematocrit, mean corpuscular measures.	Up to approximately 11 weeks
Change from baseline in clinical laboratory assessment (Clinical chemistry)	Clinical chemistry will include liver and kidney function tests along with metabolic, lipids panel and electrolytes.	Up to approximately 11 weeks
Change from baseline in clinical laboratory assessment (Urinalysis)		Up to approximately 11 weeks
Change from baseline in clinical laboratory assessment (Drug screen)		Up to approximately 11 weeks
Change from baseline in 12-lead ECG [Ventricular rate (bpm)]		Up to approximately 11 weeks
Change from baseline in 12-lead ECG [PR interval (msec)]		Up to approximately 11 weeks
Change from baseline in 12-lead ECG [QRS interval (msec)]		Up to approximately 11 weeks
Change from baseline in 12-lead ECG [QT interval (msec)]		Up to approximately 11 weeks
Change from baseline in 12-lead ECG [QTcF interval (msec)]		Up to approximately 11 weeks
Change from baseline in physical examination	A complete (body temperature, general appearance, head/eyes/ears/nose/throat, examination of thorax and abdomen, assessment of cardiac, musculoskeletal, and circulatory systems, palpations for lymphadenopathy, and limited neurological examination) and targeted organ systems physical examinations will be performed.	Up to approximately 11 weeks
Suicidal ideation scale with the use of Columbia-Suicide Severity Rating Scale (C-SSRS)		Up to approximately 11 weeks

Collaborators and Investigators

• Sponsor: Karuna Therapeutics
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): March 13, 2025
• Study Completion (Actual): March 13, 2025

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mental Disorders; BMS-986510; KarXT; DSM-5 Schizophrenia; Diagnostic and Statistical Manual of Mental Disorders
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: CN012-0048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No