A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dosed Phase II Clinical Study to Evaluate the Efficacy and Safety of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Acutely Psychotic Adult Subjects With Schizophrenia

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed phase II clinical study to evaluate the efficacy and safety of LY03020 in chinese acutely psychotic adult subjects with schizophrenia.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: LY03020

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yufeng Wang; Phone Number: 18665029373; Email: wangyufeng@luye.com

Study Locations

• China
  • Beijing, China
    • Beijing Anding Hospital Capital Medical University
    • Contact: Yang Li; Phone Number: 15810468016; Email: liyang2007428@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects and their guardians sign informed consent voluntarily.
• Male or female subject aged 18 to 65 years (inclusive).
• Subject meets DSM-5 criteria for schizophrenia and confirmed using the Mandarin for China Translation Version 7.0.2).
• According to the investigator's assessment, subject has an acute exacerbation or relapse of schizophrenia requiring hospitalization (no longer than 2 months). Continuing hospitalization does not exceed 2 weeks for patients with acute psychotic exacerbation or relapse that require the hospitalization prior to screening.
• Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions(P1), conceptual disorganization(P2), hallucinations(P3), and suspicion, victimization (P6) at screening and baseline.
• Subject must have a CGI-S score ≥ 4 at screening and baseline.

Exclusion Criteria:

• - Subject who has a history or presence of symptoms consistent with a major psychiatric disorder other than schizophrenia as defined by DSM-5;
• According to the investigator's assessment, subject has a treatment-resistant schizophrenia;
• Subject who has a history or presence of symptoms consistent with neuroleptic malignant syndrome (NMS);
• Subject has received electroconvulsive therapy treatment within 3 months prior to screening or is expected to require ECT during the study;
• History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) within 1 year prior to screening or suicidal ideation within 6 months prior to screening, defined as affirmative responses ("yes") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening/baseline;
• History or presence of the following treatments:

Within 1 week prior to randomization or within 5 half lives (whichever is longer), subject has been treated with short acting antipsychotic drugs or other psychoactive drugs (such as antidepressants, mood stabilizers, and antiepileptic drugs), except for anti-anxiety drugs or sedative hypnotic drugs that can be used according to the protocol; Within two treatment cycles prior to randomization, subject has used long-acting antipsychotic drugs; Within 4 weeks prior to randomization, subject has used monoamine oxidase inhibitors (MAOIs); Previously used sufficient amounts and periods of clozapine for the treatment of schizophrenia;

• Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate <50 beats per minute (bpm) and the abnormality has clinical significance according to the researchers' assessment at screening/baseline; or QTc >450 ms (male) / QTc >460 ms (female) based on Fridericia's formula-corrected measurements and the abnormality has clinical significance according to the researchers' assessment at screening/baseline;
• Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma;.
• Subjects with a history of orthostatic hypotension or syncope.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY03020; Subjects will take LY03020 from Day 1 to Day 48	Drug: LY03020; administered orally
Placebo Comparator: Placebo; Subjects will take Placebo from Day 1 to Day 48	Drug: Placebo; administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score	The total score is 30-210, higher score is indicative of greater symptomatology.	baseline to week 6 of maintenance treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in PANSS Positive subscale score	The PANSS Positive subscale score is 7-49, higher score is indicative of greater symptomatology.	baseline to week 6 of maintenance treatment
Change from Baseline in PANSS Negative subscale score	The PANSS Negative subscale score is 7-49, higher score is indicative of greater symptomatology.	baseline to week 6 of maintenance treatment
Change from Baseline in PANSS General Psychopathology subscale score	The PANSS General Psychopathology subscale score is 16-112, higher score is indicative of greater symptomatology.	baseline to week 6 of maintenance treatment
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score	CGI-S is 0-7 with higher score is indicative of greater symptomatology	baseline to week 6 of maintenance treatment
The Incidence of Overall AEs		baseline to week 6 of maintenance treatment

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: LY03020/CT-CHN-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No