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

NCT06572449 | Completed Phase 3 Results 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 (5)

• Number of Participants With TEAEs From First Dose to End of Study Follow up.

  Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

  From first dose to end of study follow up (63 days)

• Number of Participants With TEAEs at the End of Period 1 and Period 2.

  Number of participants with TEAEs at the end of period 1 and period 2. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

  Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)

• Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.

  Number of participants with TEAEs at the end of period 1 and period 2. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

  Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

• Number of Participants With TEAEs Leading to Treatment Discontinuation.

  Number of participants with TEAEs leading to treatment discontinuation.

  Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

• Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.

  The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.

  Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

Secondary Outcomes (8)

• Change From Baseline in PANSS Total Score, Positive Score and Negative Score

  From first dose to end of treatment (56 days)

• Change From Baseline in Marder Factor Score.

  From first dose to end of treatment (56 days)

• Change From Baseline in CGI Severity Score

  From first dose to end of treatment (56 days)

• Number of Participants With Spontaneously Reported AESIs

  From first dose to end of study follow up (63 days)

• Number of Participants With Clinically Significant Changes in Vital Signs

  From first dose to end of study follow up (63 days)

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, Inc., a Bristol Myers Squibb company: 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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2026-06

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)