A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia

Jiangsu Hansoh Pharmaceutical Co., Ltd.363 enrolled

Overview

This is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics.

This trial is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study, aims to further evaluate the efficacy and safety of HS-10380 in participants with acute schizophrenia, who were randomized (2:2:2:1:2) to receive HS-10380 ( Low Dose), HS-10380 (Medium dose), HS-10380 ( High Dose), Aripiprazole, or placebo, with the primary endpoint as the changes from baseline in PANSS total score on D42.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

363

Conditions

SCHIZOPHRENIA 1 (Disorder)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is aged 18-65 years, inclusive, at screening. * Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening. * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria. * Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening. * Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening or baseline Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: Item 1 (P1; delusions)\\Item 2 (P2; conceptual disorganization)\\Item 3 (P3; hallucinatory behavior)\\Item 6 (P6; suspiciousness/persecution). Exclusion Criteria: * Judged by the investigator as having treatment-resistant schizophrenia. * Patients with risk of violent or destructive behavior, or suicidal risk. * History or presence of clinically significant neuropsychiatric, cardiovascular, urinary, digestive, respiratory, musculoskeletal, metabolic/endocrine, hematological, immune, dermatological, and oncological systems disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. * Received electroconvulsive therapy within 3 months prior to screening, or received systemic transcranial magnetic stimulation (TMS) therapy within 1 month prior to screening. * Used clozapine or long-acting antipsychotic medications within 6 months prior to screening, or within 5 half-lives of long-acting antipsychotic medications at screening, whichever is longer. * Previous inadequate response to adequate dose and duration of aripiprazole treatment (≥20 mg/day for at least 6 weeks). * History of epilepsy (except febrile convulsions) or neuroleptic malignant syndrome. * Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria. * History of severe allergic reactions. * Female patients who are pregnant, in puerperium, or lactating at screening or baseline. * History of drug abuse within 1 year prior to screening. * History of alcohol abuse within 6 months prior to screening.

Outcomes

Primary Outcomes

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)

The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.