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.

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.