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

NCT06179108 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LB-102-003
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in the PANSS Total Score

  The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome

  Baseline to Day 28 (4 weeks)

Secondary Outcomes (1)

• Change From Baseline to Week 4 in the CGI-S Score

  28 days

Study Arms (4)

LB-102, 50 mg QD

EXPERIMENTAL

Oral LB-102: 50 mg (n \~ 105)

Drug: LB-102

LB-102, 75 mg QD

EXPERIMENTAL

Oral LB-102: 75 mg (n \~ 105)

Drug: LB-102

LB-102, 100 mg

EXPERIMENTAL

Oral LB-102: 100 mg (n \~ 35)

Drug: LB-102

Placebo comparator

PLACEBO COMPARATOR

Drug: Placebo Matched placebo tablets

Drug: LB-102

Interventions

LB-102 DRUG

LB-102 is a dopamine D2/3 and 5HT7 antagonist.

LB-102, 100 mg; LB-102, 50 mg QD; LB-102, 75 mg QD; Placebo comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• LB Pharmaceuticals Inc.: lead

Study Sites (25)

Pillar Clinical Research

Bentonville, Arkansas, 72712, United States

Location

Woodland Internation Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

CelExel Clinical Innovations

Bellflower, California, 90706, United States

Location

Synexus

Cerritos, California, 90703, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

CelExel CNS

Garden Grove, California, 92845, United States

Location

Synergy Research

Lemon Grove, California, 91945, United States

Location

CenExel CIT Riverside

Riverside, California, 92506, United States

Location

NRC Research Institute

Santa Ana, California, 92705, United States

Location

Behavioral Clinical Research, Inc.

Hollywood, Florida, 33021, United States

Location

CenExel RCA

Hollywood, Florida, 33024, United States

Location

Segal Institute for Clinical Research

Miami Lakes, Florida, 33016, United States

Location

CenExel ACMR

Atlanta, Georgia, 30331, United States

Location

CenExel iResearch

Decatur, Georgia, 30030, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Pillar Clinical Research

Chicago, Illinois, 60641, United States

Location

CenExel CBH

Gaithersburg, Maryland, 20877, United States

Location

CenExel HRI

Berlin, New Jersey, 08009, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Neuro-Behavioral Clinical Research

North Canton, Ohio, 44720, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Pillar Clinical Research

Richardson, Texas, 75080, United States

Location

Related Publications (2)

• Grattan V, Vaino AR, Prensky Z, Hixon MS. Antipsychotic Benzamides Amisulpride and LB-102 Display Polypharmacy as Racemates, S Enantiomers Engage Receptors D2 and D3, while R Enantiomers Engage 5-HT7. ACS Omega. 2019 Aug 15;4(9):14151-14154. doi: 10.1021/acsomega.9b02144. eCollection 2019 Aug 27.

  PMID: 31497735 BACKGROUND

• Biernat L, Grattan VT, Hixon MS, Prensky Z, Vaino AR. A randomized, double-blind, placebo controlled, phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of LB-102, a selective dopamine D2/3/5-HT7 inhibitor. Psychopharmacology (Berl). 2022 Sep;239(9):3009-3018. doi: 10.1007/s00213-022-06185-7. Epub 2022 Jul 16.

  PMID: 35841422 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Leslie Callahan, Head, Clinical Operations
• Organization: LB Pharmaceuticals Inc

leslie@lbpharma.us

9086556884

Study Officials

• John Kane, MD

  The Zucker Hillside Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 3:3:3:1 to receive with placebo (n \~ 105), 50 mg LB-102 QD (n \~ 105), 75 mg LB-102 QD (n \~ 105), 100 mg LB-102 QD (n \~ 35) orally.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: November 29, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)