A Phase II Study of 9MW3811 in Patients With Pathological Scar
30 de abril de 2026 actualizado por: Mabwell (Shanghai) Bioscience Co., Ltd.
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics Properties, and Preliminary Efficacy of 9MW3811 in Patients With Pathological Scar
This is a randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of 9MW3811 in patients with pathological scar.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
30
Fase
Fase
- Fase 2
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
Estudio Contacto
- Nombre: Liecheng Yang
- Número de teléfono: 021-58585793
- Correo electrónico: liecheng.yang@mabwell.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200011
- Reclutamiento
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
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Contacto:
- Tao Zan, Professor, MD, PhD
- Número de teléfono: +86 13795204523
- Correo electrónico: zantao@sjtu.edu.cn
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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
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥18 years
- Pathological scar with no spontaneous regression over the prior 6 months
- At least one scar with modified Vancouver Scar Scale (mVSS) score ≥9
- Willing to use effective contraception for 6 months after last dose (if of childbearing potential)
- Provide written informed consent
Exclusion Criteria:
- Contracture scar causing deformity
- All eligible scars either >10 cm in length and >5 cm in width, or located exclusively on sun-exposed areas (head, face, hands)
- Evidence of scar infection or active systemic infection requiring treatment
- Use of anti-scar medications (e.g., corticosteroids, immunosuppressants) or anti-scar procedures (surgery, laser, radiation, etc.) within 4 weeks prior to first dose
- Prior treatment with IL-11 cytokine or IL-6 family targeted therapy (e.g., tocilizumab) within specified washout periods
- Participation in another interventional study within 28 days
- Positive serology for HBV, HCV, HIV, or syphilis with clinical significance
- History of severe allergy or known hypersensitivity to study drug components
- Clinically significant laboratory abnormalities (eGFR <90 mL/min/1.73m², PLT <100×10⁹/L, QTc >450/470 ms, bilirubin >1.5×ULN, AST/ALT >1.5×ULN)
- Alcohol or drug abuse within 1 year
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Any other condition that, in the investigator's judgment, would compromise subject safety or study compliance
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
4
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: 9MW3811 Injection (Low Dose)
Intravenous infusion, multiple doses administered according to the protocol
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9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
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Experimental: 9MW3811 Injection (Middle Dose)
Intravenous infusion, multiple doses administered according to the protocol
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9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
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Experimental: 9MW3811 Injection (High Dose)
Intravenous infusion, multiple doses administered according to the protocol
|
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
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Comparador de placebos: Placebo
Intravenous infusion, matching placebo administered on the same schedule
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Matching placebo solution with no active ingredient, administered intravenously.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in modified Vancouver Scar Scale (mVSS) score
Periodo de tiempo: Up to Week 12
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There are 6 items in the mVSS scale (modified Vancouver Scar Scale), pigmentation, vascularity, pliability, thickness, pain, and itching.
A total of 18 points, with minimum 0 indicating normal skin and maximum 18 indicating the most scarring and worst appearance.
Change from baseline will be evaluated.
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Up to Week 12
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Assessment of adverse events (AE) / serious adverse events (SAEs)
Periodo de tiempo: Up to Week 12
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Adverse Events occurring from ICF to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 6.0.
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Up to Week 12
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Number of participants with abnormal vital signs
Periodo de tiempo: Up to Week 12
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Vital signs: include pulse, respiration, body temperature and blood pressure
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Up to Week 12
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Number of participants with abnormal Physical examination findings
Periodo de tiempo: Up to Week 12
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Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
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Up to Week 12
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Number of participants with abnormal 12-lead ECG readings
Periodo de tiempo: Up to Week 12
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12-lead ECG: HR, PR, QRS, QT, QTcF,
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Up to Week 12
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Number of participants with abnormal laboratory test results
Periodo de tiempo: Up to Week 12
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Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
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Up to Week 12
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
Periodo de tiempo: Up to Week 12
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POSAS includes observer scale (vascularity, pigmentation, thickness, relief, pliability, surface area) and patient scale (pain, itching, color, stiffness, thickness, irregularity).
Lower scores indicate improvement.
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Up to Week 12
|
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Change from baseline in Dermatology Life Quality Index (DLQI) score
Periodo de tiempo: Up to Week 12
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DLQI measures impact of skin disease on quality of life.
Total score ranges 0-30; lower scores indicate better quality of life.
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Up to Week 12
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Maximum Plasma Concentration (Cmax)
Periodo de tiempo: Up to Day 85
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To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Time to reach Cmax (Tmax)
Periodo de tiempo: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Periodo de tiempo: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Terminal elimination half-life (t1/2)
Periodo de tiempo: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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AUC from time 0 extrapolated to infinity (AUC0-inf)
Periodo de tiempo: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Terminal elimination rate constant (λz)
Periodo de tiempo: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Apparent clearance (CL)
Periodo de tiempo: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Volume of distribution (Vz)
Periodo de tiempo: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Immunogenicity: incidence of anti-drug antibodies (ADA)
Periodo de tiempo: Up to Day 85
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Percentage of participants who develop detectable ADA against 9MW3811.
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Up to Day 85
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Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pharmacodynamic biomarkers
Periodo de tiempo: Up to Day 85
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Change from baseline in blood levels of interleukin-11; Collect skin biopsy samples from the same scar lesion in patients before baseline assessment and on Day 85 to evaluate changes from baseline in: total collagen content and arrangement pattern, extracellular matrix components such as type I and type III collagen.
and expression levels of fibroblast activation markers such as α-smooth muscle actin in the lesional tissue.
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Up to Day 85
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Change from baseline in superficial vascularity distribution score in scar tissue
Periodo de tiempo: Up to Week 12
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Assessed using a 3D skin imaging device.
The scar region is selected as the ROI (region of interest), and the device's built-in red area analysis function is used to quantify vascular distribution via feature count points and a derived score.
One normal skin area adjacent to the scar serves as a control.
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Up to Week 12
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Change from baseline in red pigment (hemoglobin) and black pigment (melanin) index in scar tissue
Periodo de tiempo: Up to Week 12
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Measured by a skin colorimeter under resting conditions.
Depending on scar size, 1-4 measurement points are taken within the scar, and 2 points on adjacent normal skin.
The mean value of each region is reported as the black pigment index (unit: arbitrary scale from the device).
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Up to Week 12
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Change from baseline in skin viscoelasticity (R2 value) in scar tissue
Periodo de tiempo: Up to Week 12
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Assessed using a skin viscoelasticity meter.
R2 = Ua/Uf, where Ua is the elastic-plastic deformation during retraction and Uf is the elastic-plastic deformation during stretching.
R2 closer to 1 indicates better skin elasticity.
Depending on scar size, 1-4 measurement points are taken within the scar and 1 point on adjacent normal skin.
The mean R2 value of the scar region is reported (unit: ratio, dimensionless).
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Up to Week 12
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Change from baseline in scar thickness measured by ultrasound
Periodo de tiempo: Up to Week 12
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Scar thickness is defined as the distance from the dermal-epidermal junction to the subcutaneous fat layer (strong collagen signal region).
Ultrasound measurement is taken at the most prominent point of the scar (usually the center).
The result is reported in millimeters (mm).
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Up to Week 12
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Change from baseline in scar hardness measured by ultrasound
Periodo de tiempo: Up to Week 12
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Assessed using the tissue hardness measurement function of an ultrasound device.
The scar region is defined as the dermis from the dermal-epidermal junction to the subcutaneous fat layer.
Depending on scar size, 1-3 measurement points are taken within the scar, and the mean value is reported.
Units are as provided by the device (e.g., kilopascals [kPa] or relative stiffness units).
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Up to Week 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
Inicio del estudio
29 de diciembre de 2025
Finalización primaria (Estimado)
Finalización primaria
1 de diciembre de 2026
Finalización del estudio (Estimado)
Finalización del estudio
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
12 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
8 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
8 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
30 de abril de 2026
Última verificación
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 9MW3811-CP201
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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