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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW3811 Injection (Low Dose) | Experimental | Intravenous infusion, multiple doses administered according to the protocol |
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| 9MW3811 Injection (Middle Dose) | Experimental | Intravenous infusion, multiple doses administered according to the protocol |
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| 9MW3811 Injection (High Dose) | Experimental | Intravenous infusion, multiple doses administered according to the protocol |
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| Placebo | Placebo Comparator | Intravenous infusion, matching placebo administered on the same schedule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW3811 Injection | Drug | 9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in modified Vancouver Scar Scale (mVSS) score | 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) | 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 | Vital signs: include pulse, respiration, body temperature and blood pressure | Up to Week 12 |
| Number of participants with abnormal Physical examination findings | 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 | 12-lead ECG: HR, PR, QRS, QT, QTcF, | Up to Week 12 |
| Number of participants with abnormal laboratory test results | Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pharmacodynamic biomarkers | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liecheng Yang | Contact | 021-58585793 | liecheng.yang@mabwell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Matching placebo solution with no active ingredient, administered intravenously. |
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| Change from baseline in Dermatology Life Quality Index (DLQI) score |
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) | To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions. | Up to Day 85 |
| Time to reach Cmax (Tmax) | 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) | To determine the PK of 9MW3811 following multiple intravenous infusions. | Up to Day 85 |
| Terminal elimination half-life (t1/2) | To determine the PK of 9MW3811 following multiple intravenous infusions. | Up to Day 85 |
| AUC from time 0 extrapolated to infinity (AUC0-inf) | To determine the PK of 9MW3811 following multiple intravenous infusions. | Up to Day 85 |
| Terminal elimination rate constant (λz) | To determine the PK of 9MW3811 following multiple intravenous infusions. | Up to Day 85 |
| Apparent clearance (CL) | To determine the PK of 9MW3811 following multiple intravenous infusions. | Up to Day 85 |
| Volume of distribution (Vz) | To determine the PK of 9MW3811 following multiple intravenous infusions. | Up to Day 85 |
| Immunogenicity: incidence of anti-drug antibodies (ADA) | Percentage of participants who develop detectable ADA against 9MW3811. | Up to Day 85 |
| Up to Day 85 |
| Change from baseline in superficial vascularity distribution score in scar tissue | 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 | 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 | 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 | 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 | 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 |