NCT07369154 · LB Pharmaceuticals Inc.
52-week Open Label Safety-Tolerability Study
(NOVA3)
What this study is about
Phase 3, open label, conducted at multiple hospitals study designed to assess the long term safety and how well patients handle the treatment of LB-102 for the treatment of adult patients with stable schizophrenia
View original scientific 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
Interventions
DRUG
LB-102
LB-102 flexible dosing 50 mg - 100 mg
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provide ICF
- Patients clinically stable PANSS \</= 70 at screening
- CGI-S \</+ 3 at screening
- Medically stable
- 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
Where
- Chandler, Arizona
- Bentonville, Arkansas
- Little Rock, Arkansas
- Anaheim, California
- Cerritos, California
- Culver City, California
- San Diego, California
- Hollywood, Florida
- Miami Lakes, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Snellville, Georgia
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 27, 2026 · Source of record for eligibility and locations