SchizophreniaPhase 3NOVA2NCT07363577
Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
A Phase 3 study testing LB-102 (50 mg tablet) and LB-102 (100 mg tablet) in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 13 sites in United States.
Trial summary
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. 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 (50 mg tablet) and LB-102 (100 mg tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 13 sitesUnited States
- Study dates
- 25 Mar 2026to Oct 2027
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Pillar Clinical Research
Bentonville, Arkansas, 72712
Fayz Hudefi, MD, 479-367-2688, studies@pillarhc.com
- Recruiting
Health Synergy Clinical Research
Boynton Beach, Florida, 33426
Katherine Grigelis, 561-473-3472, kat@hscresearch.com
- Recruiting
Pillar Clinical Research
Chicago, Illinois, 60641
Roueen Rafeyan, MD, 224-534-7332, studies@pillarhc.com
Nicole Gutierrez, 479-367-2688, ngutierrez@pillarhc.com
- Recruiting
ProScience Research Group
Culver City, California, 90230
Paola Aguirre, 424-227-8127 ext. 2, paola.aguirre@proscienceerg.com
- Recruiting
CenExel
Garden Grove, California, 92845
Dakota Gainers, 714-943-5874, d.gainers@cenexel.com
- Recruiting
Synergy San Diego
Lemon Grove, California, 92064
Corey Weise, 619-303-6130, cweise@ergclinical.com
- Recruiting
Pillar Clinical Research
Little Rock, Arkansas, 72204
Leslie Smith, MD, 501-307-1919, studies@pillarhc.com
Nichole Gutierrez, 501-307-1919, ngutierrez@pillarhc.com
- Recruiting
Woodland International Research Group
Little Rock, Arkansas, 72211
Ashley Poole, 501-221-8681, apoole@ergclinical.com
- Recruiting
Innovative Clinical Research
Miami Lakes, Florida, 33016
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
North Canton, Ohio, 44720
Crystal Blackford, 330-493-1118, cblackford@nb-cr.com
- Recruiting
Clinical Innovations, Inc.
Riverside, California, 92506
Evagelos Coskinas, MD, PhD, 866-236-3935, info@CenExel.com
- Recruiting
Accelerated Clinical Trial
Snellville, Georgia, 30078
Alexis Melson, 978-255-1041, amelson@acceleratedclinicaltrials.org
- Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
Israa Diab, 314-266-1243, idiab@archclinicaltrials.com
About this study
Official title: 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.
Read the 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
- Conditions
- Schizophrenia
- Being tested
- LB-102 (50 mg tablet), LB-102 (100 mg tablet), Placebo
- Keywords
- acute schizophrenia,, exacerbated acute schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-102 (50 mg tablet)Drug
Also called LB-102
LB-102 oral tablet given for six weeks
LB-102 (100 mg tablet)Drug
Also called LB-102
LB-102 oral tablet given for six weeks
PlaceboOther
Placebo tablet given orally for six weeks
| Study group | Role | What they receive |
|---|---|---|
| LB-102 (50 mg tablet) | Experimental | • LB-102 50 mg given orally for 6 weeks Receives: Drug: LB-102 (50 mg tablet) |
| LB-102 (100 mg tablet) | Experimental | LB-102 100 mg given orally for 6 weeks Receives: Drug: LB-102 (100 mg tablet) |
| Placebo | Placebo comparator | Placebo given orally for 6 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 6 on the Positive and Negative Syndrome Scale
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
Measured: 6 weeks
Secondary outcomes (2)
Evaluate the Safety and Tolerability of LB-102
Evaluate the safety and tolerability of LB-102 in patients by evaluating adverse events
Measured: 10 weeks
Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start25 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (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
- Randomised
- Intervention model
- Sequential
- Model description
- Patients will be randomized 1:1:1 to one of three treatments
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 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
- NCT07363577
- Sponsor's protocol ID
- LB-102-008
- Acronym
- NOVA2
- Status last verified
- Jul 2026
- First submitted
- 26 Dec 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07363577
- Acronym / sponsor ID
- NOVA2 / LB-102-008
- Conditions
- Schizophrenia
- Keywords
- acute schizophrenia,, exacerbated acute schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- LB Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized 1:1:1 to one of three treatments
| Arm | Type | Receives |
|---|---|---|
| LB-102 (50 mg tablet) | Experimental | Drug: LB-102 (50 mg tablet)• LB-102 50 mg given orally for 6 weeks |
| LB-102 (100 mg tablet) | Experimental | Drug: LB-102 (100 mg tablet)LB-102 100 mg given orally for 6 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo given orally for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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-102 (50 mg tablet)Also: LB-102LB-102 oral tablet given for six weeks | Drug | LB-102 (50 mg tablet) |
| LB-102 (100 mg tablet)Also: LB-102LB-102 oral tablet given for six weeks | Drug | LB-102 (100 mg tablet) |
| PlaceboPlacebo tablet given orally for six weeks | Other | Placebo |
Primary outcome
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
2 secondary outcomes
Evaluate the Safety and Tolerability of LB-102
Time frame: 10 weeks
Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)
Time frame: 6 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 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
13 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 (50 mg tablet) and LB-102 (100 mg tablet) in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 13 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 5 inclusion and 12 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. Some participants in this study may receive a placebo. 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?
Change from baseline to Week 6 on the Positive and Negative Syndrome Scale (time frame: 6 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 27 Jul 2026.