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NCT Number: NCT07369154

52-week Open Label Safety-Tolerability Study

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chandler Clinical Trials, Chandler, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LB-102

Drug

LB-102 flexible dosing 50 mg - 100 mg

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate long term safety and tolerability

    Time frame: 52 weeks

    Evaluating the safety of treatment by number of adverse events

  2. 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

  3. Evaluate long term safety and tolerability

    Time frame: 52 weeks

    Evaluating the safety of treatment by conducting physical examinations

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Branislav Mancevski, MD

CONTACT

[email protected]

212-605-0300

Sponsors and collaborators

Lead sponsor

LB Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Acronym: NOVA3

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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