52-week Open Label Safety-Tolerability Study
NOVA3
A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia
1 other identifier
interventional
900
1 country
23
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Apr 2026
Typical duration for phase_3 schizophrenia
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
May 15, 2026
May 1, 2026
2.7 years
December 26, 2025
May 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
52 weeks
Secondary Outcomes (4)
Evaluate long term safety and tolerability
52 weeks
Evaluate long term safety and tolerability
52 weeks
Evaluate long term safety and tolerability
52 weeks
Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)
52 weeks
Study Arms (1)
LB-102
OTHERAn open label study
Interventions
Eligibility Criteria
You may qualify if:
- Provide ICF
- Patients clinically stable PANSS \</= 70 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Chandler Clinical Trials
Chandler, Arizona, 85224, United States
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
Advanced Research Center
Anaheim, California, 92805, United States
Synapse Clinical Trials
Cerritos, California, 90703, United States
ProScience Research Group
Culver City, California, 90230, United States
CenExel
Culver City, California, 92845, United States
Synergy San Diego
San Diego, California, 92064, United States
CenExel
Hollywood, Florida, 33024, United States
Segal Trials
Miami Lakes, Florida, 33063, United States
Health Synergy Clinical Research
West Palm Beach, Florida, 33407, United States
CenExel
Atlanta, Georgia, 30331, United States
Accelerated Clinical Trial
Snellville, Georgia, 30078, United States
Pillar Clinical Research
Chicago, Illinois, 60641, United States
CenExel Gaithersburg
Gaithersburg, Maryland, 20877, United States
Arch Clinical Trials
St Louis, Missouri, 63141, United States
Redbird Research
Las Vegas, Nevada, 89119, United States
Neuro-Behavioral Clinical Research
New York, New York, 11516, United States
Neuro-Behavioral Clinical Research
Canton, Ohio, 44720, United States
Adams Clinical
Philadelphia, Pennsylvania, 19104, United States
Adams Clinical
DeSoto, Texas, 75115, United States
Pillar Clinical Research
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2025
First Posted
January 27, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share