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

NCT06572449 | Completed Phase 3 FDA Drug

• 1 other identifier: CN012-0048
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 6

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.

Conditions

Schizophrenia

Keywords

BMS-986510; KarXT; DSM-5 Schizophrenia; Diagnostic and Statistical Manual of Mental Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to approximately 11 weeks

Secondary Outcomes (30)

• 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

Study Arms (1)

KarXT on empty stomach and with food

EXPERIMENTAL

Drug: KarXT

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510

KarXT on empty stomach and with food

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karuna Therapeutics: lead

Study Sites (6)

Local Institution - 0002

Los Alamitos, California, 90720-3118, United States

Location

Local Institution - 0004

Riverside, California, 92506-3257, United States

Location

Local Institution - 0006

Hollywood, Florida, 33024, United States

Location

Local Institution - 0005

Atlanta, Georgia, 30331, United States

Location

Local Institution - 0003

Decatur, Georgia, 30030, United States

Location

Local Institution - 0001

Marlton, New Jersey, 08053-3449, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia; Disease; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 27, 2024
• Study Start: October 28, 2024
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (6)