52-week Open Label Safety-Tolerability Study

NCT07369154 · tracked via the Priya Life Science USA tracker

Sponsor

LB Pharmaceuticals Inc.

Phase

Phase 3

Started

2026-04-23

Last updated

2026-09-09

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

LB-102

LB-102: LB-102 flexible dosing 50 mg - 100 mg

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Provide ICF * Patients clinically stable PANSS \</= 80 at screening * CGI-S \</+ 3 at screening * Medically stable * BMI 18 -40 * Taking oral antipsychotic treatment for at least 30 days * Have stable living environment Exclusion Criteria: * Sexually active M/F patients not willing to use highly effective contraception * Breast feeding * History of treatment resistance to schizophrenia medications * DSM-5 current diagnosis other than schizophrenia * Risk of suicidal behavior * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other

Primary outcome measure(s)

Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events. — 52 weeks
Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation

Trial sites (23)

Facility	City	Region	Status
Chandler Clinical Trials	Chandler	Arizona	Recruiting
Pillar Clinical Research	Bentonville	Arkansas	Recruiting
Pillar Clinical Research	Little Rock	Arkansas	Recruiting
Woodland International Research Group	Little Rock	Arkansas	Recruiting
Advanced Research Center	Anaheim	California	Recruiting
Synapse Clinical Trials	Cerritos	California	Recruiting
ProScience Research Group	Culver City	California	Recruiting
CenExel	Culver City	California	Recruiting
Synergy San Diego	San Diego	California	Recruiting
CenExel	Hollywood	Florida	Recruiting
Segal Trials	Miami Lakes	Florida	Recruiting
Health Synergy Clinical Research	West Palm Beach	Florida	Recruiting
CenExel	Atlanta	Georgia	Recruiting
Accelerated Clinical Trial	Snellville	Georgia	Recruiting
Pillar Clinical Research	Chicago	Illinois	Recruiting
CenExel Gaithersburg	Gaithersburg	Maryland	Recruiting
Arch Clinical Trials	St Louis	Missouri	Recruiting
Redbird Research	Las Vegas	Nevada	Recruiting
Neuro-Behavioral Clinical Research	New York	New York	Recruiting
Neuro-Behavioral Clinical Research	Canton	Ohio	Recruiting
Adams Clinical	Philadelphia	Pennsylvania	Recruiting
Adams Clinical	DeSoto	Texas	Recruiting
Pillar Clinical Research	Richardson	Texas	Recruiting

More LB Pharmaceuticals Inc. trials in the USA

Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia Recruiting

Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE. Recruiting

Other trials for the same condition

A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia Recruiting

Study of SPG302 in Adults With Schizophrenia Active, not recruiting

Study of ALTO-101 in Patients With Schizophrenia Recruiting

A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia Recruiting

Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07369154 on ClinicalTrials.gov ↗ ← All trials in the USA