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NCT07363577PHASE3Recruiting

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

LB Pharmaceuticals Inc.

Start Date

3/25/2026

Completion Date

10/1/2027

Summary

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.

Detailed Description

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Able to provide ICF * Willing to be hospitalized for duration of the study * Diagnosis of schizophrenia as defined by DSM-5 * BMI - 18-40 * PANSS 80-120 Exclusion Criteria: * Sexually active m/f not willing to adhere to highly effect birth control * Breast feeding * Increase in PANSS of \> 20% between screening and baseline * History of resistant treatment to schizophrenia medications * DSM-5 diagnosis other than schizophrenia * Risk of suicidal behavior * Risk of violent or destructive behavior * Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening * Score of ≥3 on the BARS global clinical assessment of akathisia at Screening * Insulin dependent diabetes * Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient

Interventions

DRUG

LB-102 (50 mg tablet)

DRUG

LB-102 (100 mg tablet)

OTHER

Placebo

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Conditions

Schizophrenia

Locations

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

ProScience Research Group

Culver City, California 90230

United States

CenExel

Garden Grove, California 92845

United States

Synergy San Diego

Lemon Grove, California 92064

United States

Clinical Innovations, Inc.

Riverside, California 92506

United States

Health Synergy Clinical Research

Boynton Beach, Florida 33426

United States

Innovative Clinical Research

Miami Lakes, Florida 33016

United States

Accelerated Clinical Trial

Snellville, Georgia 30078

United States

Pillar Clinical Research

Chicago, Illinois 60641

United States

Arch Clinical Trials

St Louis, Missouri 63141

United States

Neuro-Behavioral Clinical Research

North Canton, Ohio 44720

United States