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Clinical Trials in the USA / NCT07369154
Recruiting Phase 3

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
No
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)

FacilityCityRegionStatus
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

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

Other trials for the same condition

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia Active, not recruiting
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor Recruiting
Study of ALTO-101 in Patients With Schizophrenia Recruiting
A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia Recruiting
Long-Term Real-World Safety of Cobenfy in Adults With Schizophrenia Active, not 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