9MW3811 Injection: 9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Placebo: Matching placebo solution with no active ingredient, administered intravenously.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline in modified Vancouver Scar Scale (mVSS) score — Up to Week 12 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) — Up to Week 12 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 — Up to Week 12 Vital signs: include pulse, respiration, body temperature and blood pressure
Number of participants with abnormal Physical examination findings — Up to Week 12 Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
Number of participants with abnormal 12-lead ECG readings — Up to Week 12 12-lead ECG: HR, PR, QRS, QT, QTcF,
Number of participants with abnormal laboratory test results — Up to Week 12 Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
Trial sites (1)
Facility
City
Region
Status
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
More Mabwell (Shanghai) Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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