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

Karuna Therapeutics, Inc., a Bristol Myers Squibb company173 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

173

Conditions

Schizophrenia

Interventions

KarXTDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

Local Institution - 0002

Los Alamitos, California, United States

Local Institution - 0004

Riverside, California, United States

Local Institution - 0006

Hollywood, Florida, United States

Local Institution - 0005

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

The Positive and Negative Syndrome Scale (PANSS) assesses schizophrenia symptom severity using 30 items: 7 positive, 7 negative, and 16 general psychopathology scales. Each item is rated from 1 (absent) to 7 (extreme). Positive symptoms represent excesses or distortions of normal function (e.g., hallucinations, delusions), while negative symptoms reflect diminished function. The PANSS positive and negative scores each sum their respective 7 items, ranging from 7 to 49, with higher scores indicating greater severity. The PANSS Total Score sums all 30 items, ranging from 30 to 210, with higher scores reflecting worse overall symptom severity.

Time frame: From first dose to end of treatment (56 days)

Change From Baseline in Marder Factor Score.

PANSS Marder factor score is the sum of 5 negative scales and 2 general scales (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance). Participants are rated from 1 to 7 on each symptom scale, with a total score ranging from 7 to 49. Higher score indicates more severe symptoms. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Baseline is defined as the PANSS score at screening.

Time frame: From first dose to end of treatment (56 days)

Change From Baseline in CGI Severity Score

Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days. Higher score indicates more severe illness.

Time frame: From first dose to end of treatment (56 days)

Number of Participants With Spontaneously Reported AESIs

The AEs of special interest (AESIs) will be monitored and include symptomatic orthostasis, syncope(a transient loss of consciousness or fainting),and liver function test elevations as defined below. For SAE reporting requirements for events of liver injury.

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

Number of Participants With Clinically Significant Changes in Vital Signs

Number of participants with clinically significant changes in vital signs

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

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Number of participants with clinically significant changes in clinical laboratory assessments