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NCT07369154PHASE3Recruiting

52-week Open Label Safety-Tolerability Study

LB Pharmaceuticals Inc.

Start Date

4/23/2026

Completion Date

4/1/2029

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

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Provide ICF * Patients clinically stable PANSS \</= 70 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

Interventions

DRUG

LB-102

Interested in This Trial?

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Conditions

Schizophrenia

Locations

Chandler Clinical Trials

Chandler, Arizona 85224

United States

Pillar Clinical Research

Bentonville, Arkansas 72712

United States

Pillar Clinical Research

Little Rock, Arkansas 72204

United States

Woodland International Research Group

Little Rock, Arkansas 72211

United States

Advanced Research Center

Anaheim, California 92805

United States

Synapse Clinical Trials

Cerritos, California 90703

United States

ProScience Research Group

Culver City, California 90230

United States

CenExel

Culver City, California 92845

United States

Synergy San Diego

San Diego, California 92064

United States

CenExel

Hollywood, Florida 33024

United States

Segal Trials

Miami Lakes, Florida 33063

United States

Health Synergy Clinical Research

West Palm Beach, Florida 33407

United States

CenExel

Atlanta, Georgia 30331

United States

Accelerated Clinical Trial

Snellville, Georgia 30078

United States

Pillar Clinical Research

Chicago, Illinois 60641

United States

CenExel Gaithersburg

Gaithersburg, Maryland 20877

United States

Arch Clinical Trials

St Louis, Missouri 63141

United States

Redbird Research

Las Vegas, Nevada 89119

United States

Neuro-Behavioral Clinical Research

New York, New York 11516

United States

Neuro-Behavioral Clinical Research

Canton, Ohio 44720

United States

Adams Clinical

Philadelphia, Pennsylvania 19104

United States

Adams Clinical

DeSoto, Texas 75115

United States

Pillar Clinical Research

Richardson, Texas 75080

United States