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

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.

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