Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.

Key facts

Study ID: NCT06179108
Run by: LB Pharmaceuticals Inc.
People needed: 359
Starts: 2023-11-29
Expected to finish: 2024-12-04
Last updated by the study team: 2025-10-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

A patient will be eligible for inclusion in the study if they meet all of the following criteria:
Patient who is able to provide written informed consent (as required by Institutional Review Board [IRB]) prior to the initiation of any protocol-required procedures.
Must be willing to be hospitalized for the duration of the inpatient period of the study.
Have stable living environment when not in a hospital.
Male and female patients 18 to 55 years of age inclusive at the time of informed consent with a diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by the MINI 7.0.2 .
Body mass index (BMI) must be ≥18 and ≤40 kg/m2.
Patient who experiencing an acute exacerbation of psychotic symptoms, AND the patient requires hospitalization OR if already an inpatient at Screening, has been hospitalized for onset < 2 weeks for the current exacerbation.
Patients who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the Screening and Baseline visits:
Total PANSS score between 80 and 120, inclusive, and
Score of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items: Item 1 (P1; delusions), Item 2 (P2; conceptual disorganization), Item 3 (P3; hallucinatory behavior), Item 6 (P6; suspiciousness/persecution), and
CGI-S score ≥4 (moderately to severely ill).
Have received previous antipsychotic treatment (dose and duration as per the label) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the Investigator's opinion.
Have history of relapse and/or exacerbation of symptoms when they were not receiving antipsychotic treatment.
Patients willing to discontinue all prohibited psychotropic medications prior to Screening, if determined to be clinically appropriate by the Investigator, and not for the sole purpose of inclusion in the trial.

You may not qualify if…

A patient will be excluded from the study if they meet any of the following criteria:
Sex and Reproductive Status
Sexually active females of childbearing potential and male patients who are not practicing 2 different methods of birth control with their partner during the trial and for 30 days after the last dose of trial medication or who would not remain abstinent during the trial and for 30 days after the last dose.
Females who are breastfeeding or who have a positive pregnancy test result prior to receiving trial medication.
Patients who presented with a first episode of schizophrenia.
Improvement of ≥20% in total PANSS score between the Screening and Baseline assessments.
History of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (dose and duration as per the label) or required clozapine within the last 12 months.
Current DSM-5 Axis I diagnosis other than schizophrenia.
Risk for suicidal behavior during the study.
Risk of violent or destructive behavior.
Patients with clinically significant tardive dyskinesia.
Patients with a score of 3 on the Barnes Akathisia Rating Scale (BARS) global clinical assessment of akathisia.
Patients who met DSM-5 criteria for substance abuse or dependence within the past 1 year.
Patients with hypothyroidism or hyperthyroidism or clinically significant abnormal thyroid function.
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 subject or the validity of the study results.
Patients with insulin-dependent diabetes mellitus (i.e., any patient using insulin) are excluded. Patients with non-insulin-dependent diabetes mellitus may be eligible for the trial if their condition is stable as determined by satisfying ALL of the following criteria:
Glycosylated hemoglobin (HbA1c) <7.0%, and
Screening glucose must have been ≤125 mg/dL or ≤6.94 mmol/L (fasting) or <200 mg/dL or <11.1 mmol/L (nonfasting), and
Patient had been maintained on a stable regimen of oral antidiabetic medication(s) for at least 28 days prior to Screening or diabetes had been well controlled by diet for at least 28 days prior to Screening, and
Patient had no hospitalizations within the 12 months prior to Screening due to diabetes or complications related to diabetes, and
Patient's diabetes should not be newly diagnosed during Screening for the trial.
Patients with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
Patients with known ischemic heart disease or any history of myocardial infarction, congestive heart failure.
Patients with epilepsy or a history of seizures.
Patients with a positive urine drug screen or a positive blood alcohol test.

Where it is running

Pillar Clinical Research — Bentonville, Arkansas, United States
Woodland Internation Research Group — Little Rock, Arkansas, United States
Woodland Research Northwest — Rogers, Arkansas, United States
CelExel Clinical Innovations — Bellflower, California, United States
Synexus — Cerritos, California, United States
ProScience Research Group — Culver City, California, United States
CelExel CNS — Garden Grove, California, United States
Synergy Research — Lemon Grove, California, United States
CenExel CIT Riverside — Riverside, California, United States
NRC Research Institute — Santa Ana, California, United States
Behavioral Clinical Research, Inc. — Hollywood, Florida, United States
CenExel RCA — Hollywood, Florida, United States
Segal Institute for Clinical Research — Miami Lakes, Florida, United States
CenExel ACMR — Atlanta, Georgia, United States
CenExel iResearch — Decatur, Georgia, United States
Uptown Research Institute — Chicago, Illinois, United States
Pillar Clinical Research — Chicago, Illinois, United States
CenExel CBH — Gaithersburg, Maryland, United States
CenExel HRI — Berlin, New Jersey, United States
Richmond Behavioral Associates — Staten Island, New York, United States
Midwest Clinical Research Center — Dayton, Ohio, United States
Neuro-Behavioral Clinical Research — North Canton, Ohio, United States
Community Clinical Research — Austin, Texas, United States
InSite Clinical Research — DeSoto, Texas, United States
Pillar Clinical Research — Richardson, Texas, United States

Full record on ClinicalTrials.gov

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