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El ensayo clínico NCT07502105 para Esclerodermia sistémica está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis 30 Etiqueta abierta

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07502105 es un estudio intervencionista para Esclerodermia sistémica. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 2 de marzo de 2026 hasta completar 30 participantes. Dirigido por Tongji Hospital, se espera que finalice el 1 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 30 de marzo de 2026.
Resumen
This study is a single-center, single-arm, open-label, exploratory clinical trial. A total of 30 patients with diffuse cutaneous systemic sclerosis (dcSSc) will be enrolled. A historical control cohort will be established to evaluate the efficacy and safety of Firsekibart by comparing with historical data.
Título oficial

A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

Condiciones médicas
Esclerodermia sistémica
Otros ID del estudio
  • TJ-IRB202601060
Número del NCT
NCT07502105
Inicio del estudio (real)
2026-03-02
Última actualización
2026-03-30
Fecha de finalización (estimada)
2028-12-01
Inscripción (prevista)
30
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
Systemic Scleroderma
SSc
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalFirsekibart injection
Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8.
Firsekibart injection
Firsekibart, independently developed by GeneScience, was officially approved for marketing by the NMPA in July 2025 as China's first domestically developed fully human monoclonal antibody targeting IL-1β.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change in the modified Rodnan Skin Score (mRSS) from baseline
The mRSS is independently assessed by two physicians, evaluating the thickness of skin in 17 anatomic areas rated from 0 to 3, with a total score ranging from 0 to 51.
Week 12
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change in modified Rodnan skin score (mRSS) from baseline
The mRSS is independently assessed by two physicians, evaluating the thickness of skin in 17 anatomic areas rated from 0 to 3, with a total score ranging from 0 to 51.
Week 16, 24
Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline
CRISS is a weighted score and includes five core set measures: modified Rodnan skin score, FVC% predicted, health assessment questionnaire-disability index, and patient and clinician global assessments.
Week 12, 16, 24
Change from baseline in pulmonary function (FVC)
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled after the deepest possible breath.
Week 12, 16, 24
Change from baseline in pulmonary function (DLCO)
Diffusing capacity of the lungs for carbon monoxide (DLCO)is a key measure of gas diffusion across the alveolar-capillary membrane, determined by the single-breath method.
Week 12, 16, 24
Change in serum IL-1β levels from baseline
IL-1β plays an important role in inflammation and fibrosis, and its expression is aberrantly regulated in various autoimmune diseases. IL-1β is considered an effective target for diseases associated with fibrosis and tissue remodeling.
Week 12, 16, 24
Change in serum IL-6 levels from baseline
IL-1β acts as a potent upstream stimulus for IL-6 production. IL-6 activates fibroblasts, promoting their proliferation and driving the abundant synthesis of collagen and extracellular matrix components. In parallel, IL-6 induces endothelial-to-mesenchymal transition in endothelial cells, thereby exacerbating the vicious cycle between microvascular pathology and fibrosis.
Week 12, 16, 24
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  1. Age 18-70 years (inclusive), male or female.
  2. Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR diagnostic criteria.
  3. Disease duration of diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy & Medsger (2001), of ≤ 5 years (from the time of first onset of non-Raynaud's phenomenon).
  4. Modified Rodnan skin score (mRSS) ≥10;
  5. Voluntarily signed informed consent form and ability to comply with the requirements of the study protocol.

  1. Allergy to the active ingredient of Firsekibart or any of its excipients, or a history of allergy to monoclonal antibodies.
  2. Presence of any rheumatic disease other than SSc.
  3. Moderate to severe lung disease with FVC < 60% or DLCO < 50% of predicted value.
  4. Use of medications that may interfere with the evaluation of the efficacy and safety of Firsekibart, except for stable use of permitted concomitant therapies that have been maintained for at least 4 weeks prior to screening and are kept at a stable dose throughout the study period.
  5. Use of biological agents or stem cell therapy within 3 months prior to screening or within 5 half-lives of the known drug.
  6. Receipt of live or attenuated vaccines within two months prior to screening.
  7. Severe hepatic impairment, renal impairment, or hematologic abnormalities at screening.
  8. Acute or chronic infection (excluding infection complicated by finger ulceration), active infection, history of malignant tumor, or immunodeficiency disorder.
  9. Women who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period.
  10. Any other conditions that, in the investigator's judgment, render the subject ineligible for this trial.
Tongji Hospital logoTongji Hospital
Parte responsable del estudio
Lingli Dong, Investigador principal, professor; professor of medicine, Tongji Hospital
Contactos centrales del estudio
Contacto: Lingli Dong, Professor, 0086-027-83665519, [email protected]
1 Centros del estudio en 1 países

Hubei

Tongji Hospital, Tong ji Medical Colledge, Wuhan, Hubei, 430000, China
Lingli Dong, Professor, Contacto, 0086-027-83665519, [email protected]