SchizophreniaPhase 3NOVA3NCT07369154
52-week Open Label Safety-Tolerability Study
A Phase 3 study testing LB-102 in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 23 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LB-102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 23 sitesUnited States
- Study dates
- 23 Apr 2026to Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide ICF
- Patients clinically stable PANSS </= 80 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
Advanced Research Center
Anaheim, California, 92805
Halynn Nguyen, 714-999-6688, hnguyen@arctrials.com
- Recruiting
CenExel
Atlanta, Georgia, 30331
Amber Tannahill, 404-881-5800, a.tannahill@cenexel.com
- Recruiting
Pillar Clinical Research
Bentonville, Arkansas, 72712
Nicole Gutierrez, 479-367-2688, ngutierrez@pillarhc.com
Fayz Hudefi, MD
- Recruiting
Neuro-Behavioral Clinical Research
Canton, Ohio, 44720
Crystal Blackford, 330-493-1118, cblackford@nb-cr.com
Nate Fontes, 330-493-1118
- Recruiting
Synapse Clinical Trials
Cerritos, California, 90703
Paige Mansfield, 949-350-0492, p.mansfield@synapsetrials.com
- Recruiting
Chandler Clinical Trials
Chandler, Arizona, 85224
Anna Mangus, 480-716-4590, amangus@chandlertrials.com
Lauryn Shearer, 480-716-4590, lshearer@chandlertrials.com
- Recruiting
Pillar Clinical Research
Chicago, Illinois, 60641
Nichole Gutierrez, 479-367-2688, ngutierrez@pillarhc.com
Betty Davis, bdavis@pillarhc.com
- Recruiting
ProScience Research Group
Culver City, California, 90230
Paola Aguirre, 424-227-8127 ext. 2, paola.aguirre@proscienceerg.com
- Recruiting
CenExel
Culver City, California, 92845
Dakota Gainers, 714-943-5874, d.gainers@cenexel.com
- Recruiting
Adams Clinical
DeSoto, Texas, 75115
Ben Kurian, MD, MPH, 972-544-6121 ext. 1223, bkurian@adamsclinical.com
Jaya Koonjbearry, 945-293-7506 ext. 1407, jkoonjbearry@adamsclinical.com
- Recruiting
CenExel Gaithersburg
Gaithersburg, Maryland, 20877
Evan Covington, 301-251-4702, e.covington@cenexel.com
- Recruiting
CenExel
Hollywood, Florida, 33024
Anna Molero, 954-990-7649, a.molero@cenexel.com
Aliarys Alcantara, 954-990-7649, a.alcantara@cenexel.com
- Recruiting
Redbird Research
Las Vegas, Nevada, 89119
Pamela Pioquinto, 702-577-200, pamela@redbird-research.com
Eline Kalamkaryan, 702-577-2000, eline@redbird-research.com
- Recruiting
Pillar Clinical Research
Little Rock, Arkansas, 72204
Nichole Gutierrez, 501-307-1919, ngutierrez@pillarhc.com
Leslie Smith, MD
- Recruiting
Woodland International Research Group
Little Rock, Arkansas, 72211
Ashley Poole, 501-221-8681, apoole@ergclinical.com
- Recruiting
Segal Trials
Miami Lakes, Florida, 33063
Melissa Rodco, 305-722-8444 ext. 6006, mrodco@segaltrials.com
Luis Sotolongo, 305-722-8444 ext. 3611, lsotolongo@segaltrials.com
- Recruiting
Neuro-Behavioral Clinical Research
New York, New York, 11516
Cameron Anthony, 516-295-7230, canthony@NBReasearch.com
- Recruiting
Adams Clinical
Philadelphia, Pennsylvania, 19104
Cassie Blanchard, 267-207-2511, cblanchard@adamsclinical.com
Isabel Bear, ibear@adamsclinical.com
- Recruiting
Pillar Clinical Research
Richardson, Texas, 75080
Scott Bartley, MD, 214-396-4844, studies@pillarhc.com
- Recruiting
Synergy San Diego
San Diego, California, 92064
Corey Weise, 619-303-6130, cweise@ergclinical.com
- Recruiting
Accelerated Clinical Trial
Snellville, Georgia, 30078
Alexis Melson, 678-255-1041, amelson@acceleratedclinicaltrials.org
- Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
Israa Diab, 314-266-1243, idiab@archclinicaltrials.com
- Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
Katherine Grigelis, 561-473-3472, kat@hscresearch.com
About this study
Official title: 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
Read the 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
- Conditions
- Schizophrenia
- Being tested
- LB-102
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-102Drug
LB-102 flexible dosing 50 mg - 100 mg
| Study group | Role | What they receive |
|---|---|---|
| LB-102 | Other | An open label study Receives: Drug: LB-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.
Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation
Measured: 52 weeks
Secondary outcomes (4)
Evaluate long term safety and tolerability
Evaluating the safety of treatment by number of adverse events
Measured: 52 weeks
Evaluate long term safety and tolerability
Evaluating the safety of treatment by change in vital signs, electrocardiogram (QTC), and weight/height for BMI
Measured: 52 weeks
Evaluate long term safety and tolerability
Evaluating the safety of treatment by conducting physical examinations
Measured: 52 weeks
Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start23 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LB Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369154
- Sponsor's protocol ID
- LB-102-010
- Acronym
- NOVA3
- Status last verified
- Sep 2026
- First submitted
- 26 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07369154
- Acronym / sponsor ID
- NOVA3 / LB-102-010
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- LB Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study
| Arm | Type | Receives |
|---|---|---|
| LB-102 | Other | Drug: LB-102An open label study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide ICF
- Patients clinically stable PANSS </= 80 at screening
- CGI-S </+ 3 at screening
- Medically stable
- BMI 18 -40
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB-102LB-102 flexible dosing 50 mg - 100 mg | Drug | LB-102 |
Primary outcome
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
4 secondary outcomes
Evaluate long term safety and tolerability
Time frame: 52 weeks
Evaluate long term safety and tolerability
Time frame: 52 weeks
Evaluate long term safety and tolerability
Time frame: 52 weeks
Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LB-102 in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Branislav Mancevski, MD (212-605-0300, clinicaltrials@lbpharma.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.