Phase II test of 9MW3811 for pathological scars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase II trial testing 9MW3811 injections in adults with pathological scars. The study measures clinical efficacy alongside safety, tolerability, pharmacokinetics, and immunogenicity. Eligible participants must be ≥18 years old, have at least one scar with a modified Vancouver Scar Scale (mVSS) score ≥9 and no spontaneous regression in the prior 6 months. Key exclusions include contracture scars causing deformity, very large or exclusively sun-exposed scars, active infection, recent anti-scar treatments, prior IL‑11 or IL‑6 family targeted therapy, and positive viral serology for HBV/HCV/HIV or syphilis.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Liecheng Yang
• Email: liecheng.yang@mabwell.com
• Phone: 021-58585793

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.