52-week Open Label Safety-Tolerability Study (NOVA3)

May 13, 2026 updated by: LB Pharmaceuticals Inc.

A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

900

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
    • Arizona
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pillar Clinical Research
        • Principal Investigator:
          • Fayz Hudefi, MD
        • Contact:
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
        • Contact:
      • Little Rock, Arkansas, United States, 72204
        • Pillar Clinical Research
        • Principal Investigator:
          • Leslie Smith, MD
        • Contact:
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center
        • Contact:
      • Cerritos, California, United States, 90703
      • Culver City, California, United States, 90230
      • Culver City, California, United States, 92845
      • San Diego, California, United States, 92064
    • Florida
      • Hollywood, Florida, United States, 33024
      • Miami Lakes, Florida, United States, 33063
      • West Palm Beach, Florida, United States, 33407
        • Health Synergy Clinical Research
        • Contact:
    • Georgia
    • Illinois
      • Chicago, Illinois, United States, 60641
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
    • Missouri
      • St Louis, Missouri, United States, 63141
    • Nevada
    • New York
      • New York, New York, United States, 11516
        • Neuro-Behavioral Clinical Research
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44720
        • Neuro-Behavioral Clinical Research
        • Contact:
        • Contact:
          • Nate Fontes
          • Phone Number: 330-493-1118
    • Pennsylvania
    • Texas
      • DeSoto, Texas, United States, 75115
      • Richardson, Texas, United States, 75080
        • Pillar 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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LB-102
An open label study
Drug: LB-102
LB-102 flexible dosing 50 mg - 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.
Time Frame: 52 weeks
Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate long term safety and tolerability
Time Frame: 52 weeks
Evaluating the safety of treatment by number of adverse events
52 weeks
Evaluate long term safety and tolerability
Time Frame: 52 weeks
Evaluating the safety of treatment by change in vital signs, electrocardiogram (QTC), and weight/height for BMI
52 weeks
Evaluate long term safety and tolerability
Time Frame: 52 weeks
Evaluating the safety of treatment by conducting physical examinations
52 weeks
Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)
Time Frame: 52 weeks
Change in Positive and Negative Syndrome Scale (PANSS) from Baseline to end of treatment where a decrease in score likely indicate response to treatment whereas an increase in score may indicate a worsening of disease where an increase in the scale score may indicate a worsening of disease and decrease in score likely indicates response to treatment.
52 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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB-102-010

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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