LB-102 treatment for adults with acute schizophrenia
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 trial will test whether taking LB-102 once daily (50 mg or 100 mg) helps adults hospitalized for an acute schizophrenia episode compared with placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 456 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | LB Pharmaceuticals Inc. Industry-sponsored |
| Locations | 13 sites (Bentonville, Arkansas and 12 other locations) |
| Trial ID | NCT07363577 on ClinicalTrials.gov |
What this trial studies
This Phase 3, randomized, double-blind, placebo-controlled, fixed-dose multicenter trial compares once-daily LB-102 (50 mg and 100 mg) with placebo in adults experiencing an acute exacerbation of schizophrenia. Participants are hospitalized for the duration of the study and randomized to one of the three arms. The study tracks symptom change (including PANSS scores), safety, tolerability, and pharmacokinetics. Key eligibility includes DSM-5 schizophrenia diagnosis, PANSS 80–120, BMI 18–40, ability to consent, and agreement to required contraception where applicable.
Who should consider this trial
Good fit: Adults with DSM-5 schizophrenia experiencing an acute exacerbation who meet PANSS and BMI criteria, can provide informed consent, are willing to be hospitalized, and agree to contraception requirements are the ideal candidates.
Not a fit: People with treatment-resistant schizophrenia, other primary DSM-5 diagnoses, high suicidal or violent risk, significant cardiac or metabolic conditions, breastfeeding women, or those unwilling to use effective birth control are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, LB-102 could offer a new oral treatment option that more quickly reduces acute schizophrenia symptoms while being tolerable for patients.
How similar studies have performed: Other phase 3 fixed-dose, placebo-controlled trials of oral antipsychotics have demonstrated benefit in acute schizophrenia, but LB-102 itself is a novel compound without prior phase 3 proof of efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Bentonville, Arkansas and 12 other locations
- Pillar Clinical Research — Bentonville, Arkansas, United States (Recruiting)
- Pillar Clinical Research — Little Rock, Arkansas, United States (Recruiting)
- Woodland International Research Group — Little Rock, Arkansas, United States (Recruiting)
- ProScience Research Group — Culver City, California, United States (Recruiting)
- CenExel — Garden Grove, California, United States (Recruiting)
- Synergy San Diego — Lemon Grove, California, United States (Recruiting)
- Clinical Innovations, Inc. — Riverside, California, United States (Recruiting)
- Health Synergy Clinical Research — Boynton Beach, Florida, United States (Recruiting)
- Innovative Clinical Research — Miami Lakes, Florida, United States (Recruiting)
- Accelerated Clinical Trial — Snellville, Georgia, United States (Recruiting)
- Pillar Clinical Research — Chicago, Illinois, United States (Recruiting)
- Arch Clinical Trials — St Louis, Missouri, United States (Recruiting)
- Neuro-Behavioral Clinical Research — North Canton, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Anna Eramo, MD
- Email: clinicaltrials@lbpharma.us
- Phone: 212-605-0300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.