NCT07369154

52-week Open Label Safety-Tolerability Study

A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: LB Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia

Detailed description

Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia who are experiencing inadequate response or who are having issues with side effects, general tolerability, or overall effectiveness of their current antipsychotic medication and desire to change medications, or who have completed their participation in current LB-102 clinical studies

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	LB-102	LB-102 flexible dosing 50 mg - 100 mg

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-01
• Completion: 2029-04-01
• First posted: 2026-01-27
• Last updated: 2026-04-09

Regulatory

• FDA-regulated drug study