Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
NOVA2
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
1 other identifier
interventional
456
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Mar 2026
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
March 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
May 6, 2026
May 1, 2026
1.2 years
December 26, 2025
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 weeks
Secondary Outcomes (2)
Evaluate the Safety and Tolerability of LB-102
10 weeks
Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)
6 weeks
Study Arms (3)
LB-102 (50 mg tablet)
EXPERIMENTAL• LB-102 50 mg given orally for 6 weeks
LB-102 (100 mg tablet)
EXPERIMENTALLB-102 100 mg given orally for 6 weeks
Placebo
PLACEBO COMPARATORPlacebo given orally for 6 weeks
Interventions
LB-102 oral tablet given for six weeks
LB-102 oral tablet given for six weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Pillar Clinical Research
Bentonville, Arkansas, 72712, United States
Pillar Clinical Research
Little Rock, Arkansas, 72204, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
ProScience Research Group
Culver City, California, 90230, United States
CenExel
Garden Grove, California, 92845, United States
Synergy San Diego
Lemon Grove, California, 92064, United States
Clinical Innovations, Inc.
Riverside, California, 92506, United States
Health Synergy Clinical Research
Boynton Beach, Florida, 33426, United States
Innovative Clinical Research
Miami Lakes, Florida, 33016, United States
Accelerated Clinical Trial
Snellville, Georgia, 30078, United States
Pillar Clinical Research
Chicago, Illinois, 60641, United States
Arch Clinical Trials
St Louis, Missouri, 63141, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2025
First Posted
January 23, 2026
Study Start
March 25, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share