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

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.

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.

Number of participants with abnormal vital signs

Vital signs: include pulse, respiration, body temperature and blood pressure

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

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.

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.

Maximum Plasma Concentration (Cmax)

To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.

Time to reach Cmax (Tmax)

To determine the PK of 9MW3811 following multiple intravenous infusions.

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.

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.

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).

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).