NCT05304767

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Xanomeline and Trospium Chloride Capsules	KarXT 50 mg/20 mg BID KarXT 75mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID

Timeline

• Start date: 2022-03-07
• Primary completion: 2026-03-19
• Completion: 2026-03-19
• First posted: 2022-03-31
• Last updated: 2026-03-11

Locations

175 sites across 9 countries: United States, Bulgaria, Czechia, India, Japan, Poland, Romania, Serbia, United Kingdom

Regulatory

• FDA-regulated drug study