NCT06179108

Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: LB Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.

Detailed description

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to examine the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. The primary objective of the study is to assess the efficacy of LB-102 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores at day 28 in approximately 350 adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in CGI-S, PANSS subscale and Marder Factor scores, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia. The duration of treatment of the study is 28 days (4 weeks). Patients in this study will be randomized 3:3:3:1 to receive either: placebo, 50 mg QD LB-102, 75 mg QD LB-102, or 100 mg QD LB-102; that is, \~105 patients will get placebo, \~105 will get 50 mg LB-102 QD, \~105 will get 75 mg LB-102 QD, \~35 will get 100 mg LB-102 QD. LB-102 will be dosed orally once a day. Pharmacokinetic data will be measured for the first 60 patients in this study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	LB-102	LB-102 is a dopamine D2/3 and 5HT7 antagonist.

Timeline

• Start date: 2023-11-29
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2023-12-21
• Last updated: 2025-10-22
• Results posted: 2025-10-22

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study