Actively Recruiting
A Phase II Study 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
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 present without spontaneous regression for at least 6 months
- At least one scar with a modified Vancouver Scar Scale (mVSS) score of 9 or more
- Willingness to use effective contraception for 6 months after last dose if of childbearing potential
- Ability to provide written informed consent
You will not qualify if you...
- Presence of contracture scar causing deformity
- 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 before first dose
- Prior treatment with IL-11 cytokine or IL-6 family targeted therapy within required 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 including low kidney function, low platelets, abnormal heart rhythm, or elevated liver enzymes
- Alcohol or drug abuse within the past year
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Any other condition that might affect participant safety or study compliance as determined by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
L
Liecheng Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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