CompletedPhase 2

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

China363 participantsStarted 2024-05-23

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-act…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 2 trial of HS-10380, what do we know so far about its safety profile compared to schizophrenia medications I might already be familiar with, given that Phase 2 studies are still in early stages of establishing that information?
2The trial measured changes in PANSS scores over 6 weeks in hospitalized patients — does my current symptom severity and living situation match the kind of patients who were enrolled, and would that affect whether these results are relevant to me?
3Now that this trial is completed, has any of the data been published or shared, and what did the results suggest about how well HS-10380 reduced positive and negative symptoms of schizophrenia?
4Would starting or staying on a currently approved schizophrenia treatment be a better first step for me right now, rather than waiting to see if HS-10380 moves forward to a later-phase trial?
5If HS-10380 does advance to a Phase 3 trial based on these results, is that something worth monitoring, and how would you recommend I stay informed about whether I might be a candidate for future studies?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and Week 6

Trial details

NCT IDNCT07550387

SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-02

View on ClinicalTrials.gov More SCHIZOPHRENIA 1 (Disorder) trials