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New treatment option for Scar
Official title A Phase II Study of 9MW3811 in Patients With Pathological Scar
ClinicalTrials.gov ID: NCT07576608
What this study is testing
What is 9MW3811 Injection?
9MW3811 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for scar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 treatment with IL-11 cytokine or IL-6 family targeted therapy (e.g., tocilizumab) within specified washout periods
- Participation in another treatment study within 28 days
See the full eligibility 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
- 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 treatment 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.