An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) in subjects with schizophrenia.

NCT Number	NCT05304767
Lead Sponsor	Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions	Schizophrenia
Enrollment	290 participants
Start Date	2022-03-07
Primary Completion	2026-03-25 (estimated)
Study Completion	2026-03-25 (estimated)
Updated on ClinicalTrials.gov	2026-07-31