Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia (NOVA2)

May 5, 2026 updated by: LB Pharmaceuticals Inc.

A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

456

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Recruiting
        • Pillar Clinical Research
        • Contact:
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group
        • Contact:
      • Little Rock, Arkansas, United States, 72204
    • California
      • Culver City, California, United States, 90230
      • Garden Grove, California, United States, 92845
      • Lemon Grove, California, United States, 92064
      • Riverside, California, United States, 92506
        • Recruiting
        • Clinical Innovations, Inc.
        • Contact:
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Recruiting
        • Health Synergy Clinical Research
        • Contact:
      • Miami Lakes, Florida, United States, 33016
    • Georgia
    • Illinois
      • Chicago, Illinois, United States, 60641
    • Missouri
      • St Louis, Missouri, United States, 63141
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro-Behavioral Clinical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LB-102 (50 mg tablet)
• LB-102 50 mg given orally for 6 weeks
Drug: LB-102 (50 mg tablet)
LB-102 oral tablet given for six weeks
Other Names:
  • LB-102
Experimental: LB-102 (100 mg tablet)
LB-102 100 mg given orally for 6 weeks
Drug: LB-102 (100 mg tablet)
LB-102 oral tablet given for six weeks
Other Names:
  • LB-102
Placebo Comparator: Placebo
Placebo given orally for 6 weeks
Other: Placebo
Placebo tablet given orally for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to Week 6 on the Positive and Negative Syndrome Scale
Time Frame: 6 weeks
Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Safety and Tolerability of LB-102
Time Frame: 10 weeks
Evaluate the safety and tolerability of LB-102 in patients by evaluating adverse events
10 weeks
Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)
Time Frame: 6 weeks
Assess the effect of LB-102 on the treatment for schizophrenia, as determined by a change from Baseline in the Clinical Global Impressions Severity of Illness scale: whereas increase demonstrates worsening of illness and decrease in score likely indicates response to treatment
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LB Pharmaceuticals Inc.

Investigators

  • Principal Investigator: John Kane, MD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB-102-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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