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

NCT07396870 | Not Yet Recruiting Phase 2

• 1 other identifier: LY03020/CT-CHN-204
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from Baseline in PANSS Positive subscale score

  baseline to week 6 of maintenance treatment

• Change from Baseline in PANSS Negative subscale score

  baseline to week 6 of maintenance treatment

• Change from Baseline in PANSS General Psychopathology subscale score

  baseline to week 6 of maintenance treatment

• Change from Baseline in Clinical Global Impression-Severity (CGI-S) score

  baseline to week 6 of maintenance treatment

• The Incidence of Overall AEs

  baseline to week 6 of maintenance treatment

Study Arms (2)

LY03020

EXPERIMENTAL

Subjects will take LY03020 from Day 1 to Day 48

Drug: LY03020

Placebo

PLACEBO COMPARATOR

Subjects will take Placebo from Day 1 to Day 48

Drug: Placebo

Interventions

Placebo DRUG

administered orally

Placebo

LY03020 DRUG

administered orally

LY03020

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Beijing AnDing Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Yufeng Wang

CONTACT

18665029373; wangyufeng@luye.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)