Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of 9MW3811 in Patients With Pathological Scar
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug 9MW3811 in a randomized, double-blind, placebo-controlled Phase II study involving patients with pathological scars. The study aims to assess the drugs safety, tolerability, pharmacokinetics, immunogenicity, and preliminary effectiveness in improving scar conditions. Participants will have scars that have not improved spontaneously in the past six months and meet certain severity criteria. Participants will receive multiple intravenous infusions of either low, middle, or high doses of 9MW3811 or a matching placebo according to the study protocol. The treatment phase includes administration over a period up to 12 weeks, with dosing schedules designed to monitor responses and side effects closely. The study compares the effects of the different dosage levels of 9MW3811 against placebo. During the study, participants will undergo regular assessments including modified Vancouver Scar Scale scoring, patient and observer scar evaluations, quality of life questionnaires, vital sign checks, physical exams, ECGs, and laboratory tests. Pharmacokinetic properties such as plasma concentration and antibody development will be monitored up to day 85. The study includes careful safety monitoring and will follow participants for up to 12 weeks after treatment begins.
CONDITIONS
Brief Title
A Phase II Study of 9MW3811 in Patients With Pathological Scar
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathological scar with no spontaneous regression over the prior 6 months
- At least one scar with modified Vancouver Scar Scale (mVSS) score 9 or higher
- Willing to use effective contraception for 6 months after last dose if of childbearing potential
- Provide written informed consent
You will not qualify if you...
- Contracture scar causing deformity
- All eligible scars larger than 10 cm in length and 5 cm in width or located only on sun-exposed areas (head, face, hands)
- Evidence of scar infection or active systemic infection requiring treatment
- Use of anti-scar medications or procedures within 4 weeks prior to first dose
- Prior treatment with IL-11 cytokine or IL-6 family targeted therapy 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 hypersensitivity to study drug components
- Clinically significant laboratory abnormalities (eGFR below 90 mL/min/1.73m2, platelet count below 100x10^9/L, QTc over 450/470 ms, bilirubin over 1.5 times upper limit, AST/ALT over 1.5 times upper limit)
- Alcohol or drug abuse within 1 year
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Any other condition that may compromise safety or study compliance
Research Team
L
Liecheng Yang
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