Phase II test of 9MW3811 for pathological scars

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 trial will try injections of 9MW3811 to see if they improve pathological scars in adults compared with placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (industry)
• Drugs / interventions: tocilizumab, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07576608 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with pathological scars that have not improved for at least six months and who have at least one scar with mVSS ≥9 and can comply with study visits and contraception requirements.

Not a fit: Patients with contracture deforming scars, very large or exclusively sun-exposed scars, active infection, recent anti-scar procedures or medications, prior IL-11/IL-6 family therapy, or positive hepatitis/HIV/syphilis tests would be excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, 9MW3811 could reduce scar severity and improve the appearance and symptoms of pathological scars.

How similar studies have performed: Targeting IL‑11/related pathways for pathological scarring is relatively novel and there is limited prior clinical evidence specifically supporting this approach for scars.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Liecheng Yang

Conditions: Scar