A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia
7 de agosto de 2026 actualizado por: Jiangsu Hansoh Pharmaceutical Co., Ltd.
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety of HS-10380 in Chinese Adult Patients With Schizophrenia
The primary purpose of this open-label phase 3 study is to evaluate the safety of HS-10380 on the incidence, severity, relationship to investigational product of adverse events (AE), serious adverse events (SAE), and adverse events leading to study drug discontinuationin Chinese adult participants with schizophrenia.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
The study will comprise 3 periods : a Screening Period, an Open-Label Treatment Period during which participants will be treated for 52 weeks and a 14-day Follow-up Period before an End of Study (EOS) Visit.
The total study duration for each participant on this study is 57 weeks.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
500
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Tianmei Si
- Número de teléfono: 010-62723761
- Correo electrónico: si.tian-mei@163.com
Ubicaciones de estudio
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Porcelana, 100191
- Peking University Sixth Hospital
-
Contacto:
- Tianmei Si
- Número de teléfono: 010-62723761
- Correo electrónico: si.tian-mei@163.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
- Willing and able to give informed consent/assent as per local requirements.
- Participants are willing and able to discontinue all antipsychotic medications prior to the baseline visit, as determined by the investigator.
Exclusion Criteria:
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- 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 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.
- 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.
- Abnormal physical examination findings、vital signs or 12-lead electrocardiogram (ECG) at screening .
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HS-10380 (1.5-6mg)
|
Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence and severity of adverse events (AE)
Periodo de tiempo: From first dose to end of study (Up to approximately 54 weeks )
|
TEAEs are defined as events with an onset date on or after the first dose of HS-10380.
An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event.
|
From first dose to end of study (Up to approximately 54 weeks )
|
|
Incidence and severity of serious adverse events (SAE)
Periodo de tiempo: From first dose to end of study (Up to approximately 52 weeks)
|
An SAE is any untoward medical occurrence, in the view of either the investigator or sponsor, that results in death; is life-threatening; results in inpatient hospitalization or prolongation of existing hospitalization ; results in persistent or significant disability/incapacity, and/or; is a congenital anomaly/birth defect.
|
From first dose to end of study (Up to approximately 52 weeks)
|
|
Incidence of Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation
Periodo de tiempo: From first dose to end of study (Up to approximately 54 weeks )
|
TEAEs are defined as events with an onset date on or after the first dose of HS-10380.
An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event.
|
From first dose to end of study (Up to approximately 54 weeks )
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Periodo de tiempo: Open-label extension baseline, week 52
|
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales.
Participants are rated from 1 to 7 on each symptom scale.
The positive symptoms in schizophrenia are the excess or distortion of normal function and the negative symptoms are the diminution or loss of normal functions .
PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210.
Higher scores indicate more severe symptoms.
|
Open-label extension baseline, week 52
|
|
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score
Periodo de tiempo: Open-label extension baseline, week 52
|
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?"
The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
|
Open-label extension baseline, week 52
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
9 de septiembre de 2026
Finalización primaria (Estimado)
31 de julio de 2028
Finalización del estudio (Estimado)
31 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
7 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2026
Publicado por primera vez (Actual)
12 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HS-10380-303
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .