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
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Clinical Innovations, Inc.
RECRUITING
Riverside
Contact Information
Primary
Anna Eramo, MD
Anna@lbpharma.us
212-605-0300
Backup
Branislav Mancevski, MD
bmancevski@lbpharma.us
212-605-0300
Time Frame
Start Date: 2026-03-25
Estimated Completion Date: 2027-10
Participants
Target number of participants: 456
Treatments
Experimental: LB-102 (50 mg tablet)
• LB-102 50 mg given orally for 6 weeks
Experimental: LB-102 (100 mg tablet)
LB-102 100 mg given orally for 6 weeks
Placebo_comparator: Placebo
Placebo given orally for 6 weeks
Related Therapeutic Areas
Sponsors
Leads: LB Pharmaceuticals Inc.