Last updated 45 hours ago

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

472 patients around the world

Available in United States, Argentina

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

472Patients around the world

This study is for people with

Schizophrenia

To 65 Years

All Gender

: Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1.
Item 1 (P1; delusions).
Item 2 (P2; conceptual disorganization).
Item 3 (P3; hallucinatory behavior).
Item 6 (P6; suspiciousness/persecution).
Participant must have a CGI-S score of ≥ 4 at screening and Day -1.
Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

: Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
Participant must not have a history of treatment resistance to schizophrenia medications.
Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
Other protocol-defined Inclusion/Exclusion criteria apply.

SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Study typeInterventional

Conditions

Schizophrenia

Requirements

To 65 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07686263