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A Phase II Study of 9MW3811 in Patients With Pathological Scar

2026年4月30日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200011
        • 招聘中
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：9MW3811 Injection (Low Dose)
Intravenous infusion, multiple doses administered according to the protocol
药品：9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
实验性的：9MW3811 Injection (Middle Dose)
Intravenous infusion, multiple doses administered according to the protocol
药品：9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
实验性的：9MW3811 Injection (High Dose)
Intravenous infusion, multiple doses administered according to the protocol
药品：9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
安慰剂比较：Placebo
Intravenous infusion, matching placebo administered on the same schedule
药品：Placebo
Matching placebo solution with no active ingredient, administered intravenously.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in modified Vancouver Scar Scale (mVSS) score
大体时间：Up to Week 12
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.
Up to Week 12
Assessment of adverse events (AE) / serious adverse events (SAEs)
大体时间：Up to Week 12
Adverse Events occurring from ICF to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 6.0.
Up to Week 12
Number of participants with abnormal vital signs
大体时间：Up to Week 12
Vital signs: include pulse, respiration, body temperature and blood pressure
Up to Week 12
Number of participants with abnormal Physical examination findings
大体时间：Up to Week 12
Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
Up to Week 12
Number of participants with abnormal 12-lead ECG readings
大体时间：Up to Week 12
12-lead ECG: HR, PR, QRS, QT, QTcF,
Up to Week 12
Number of participants with abnormal laboratory test results
大体时间：Up to Week 12
Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
Up to Week 12

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
大体时间：Up to Week 12
POSAS includes observer scale (vascularity, pigmentation, thickness, relief, pliability, surface area) and patient scale (pain, itching, color, stiffness, thickness, irregularity). Lower scores indicate improvement.
Up to Week 12
Change from baseline in Dermatology Life Quality Index (DLQI) score
大体时间：Up to Week 12
DLQI measures impact of skin disease on quality of life. Total score ranges 0-30; lower scores indicate better quality of life.
Up to Week 12
Maximum Plasma Concentration (Cmax)
大体时间：Up to Day 85
To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Time to reach Cmax (Tmax)
大体时间：Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
大体时间：Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Terminal elimination half-life (t1/2)
大体时间：Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
AUC from time 0 extrapolated to infinity (AUC0-inf)
大体时间：Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Terminal elimination rate constant (λz)
大体时间：Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Apparent clearance (CL)
大体时间：Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Volume of distribution (Vz)
大体时间：Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Immunogenicity: incidence of anti-drug antibodies (ADA)
大体时间：Up to Day 85
Percentage of participants who develop detectable ADA against 9MW3811.
Up to Day 85

其他结果措施

结果测量
措施说明
大体时间
Change in pharmacodynamic biomarkers
大体时间：Up to Day 85
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.
Up to Day 85
Change from baseline in superficial vascularity distribution score in scar tissue
大体时间：Up to Week 12
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.
Up to Week 12
Change from baseline in red pigment (hemoglobin) and black pigment (melanin) index in scar tissue
大体时间：Up to Week 12
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).
Up to Week 12
Change from baseline in skin viscoelasticity (R2 value) in scar tissue
大体时间：Up to Week 12
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).
Up to Week 12
Change from baseline in scar thickness measured by ultrasound
大体时间：Up to Week 12
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).
Up to Week 12
Change from baseline in scar hardness measured by ultrasound
大体时间：Up to Week 12
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).
Up to Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mabwell (Shanghai) Bioscience Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月29日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年4月12日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 9MW3811-CP201

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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