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Recruiting NCT07576608

A Phase II Study of 9MW3811 in Patients With Pathological Scar

Phase II Interventional Scar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 9MW3811 Injection, Placebo.
Who it may be relevant to
Registry conditions: Scar. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 9MW3811 Injection
    9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
  • Drug Placebo
    Matching placebo solution with no active ingredient, administered intravenously.

Primary outcome measures

  • Change from baseline in modified Vancouver Scar Scale (mVSS) score [Time frame: Up to Week 12]
  • Assessment of adverse events (AE) / serious adverse events (SAEs) [Time frame: Up to Week 12]
  • Number of participants with abnormal vital signs [Time frame: Up to Week 12]
  • Number of participants with abnormal Physical examination findings [Time frame: Up to Week 12]
  • Number of participants with abnormal 12-lead ECG readings [Time frame: Up to Week 12]
  • Number of participants with abnormal laboratory test results [Time frame: Up to Week 12]
Secondary outcome measures (11)
  • Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score [Time frame: Up to Week 12]
  • Change from baseline in Dermatology Life Quality Index (DLQI) score [Time frame: Up to Week 12]
  • Maximum Plasma Concentration (Cmax) [Time frame: Up to Day 85]
  • Time to reach Cmax (Tmax) [Time frame: Up to Day 85]
  • Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) [Time frame: Up to Day 85]
  • Terminal elimination half-life (t1/2) [Time frame: Up to Day 85]
  • AUC from time 0 extrapolated to infinity (AUC0-inf) [Time frame: Up to Day 85]
  • Terminal elimination rate constant (λz) [Time frame: Up to Day 85]
  • Apparent clearance (CL) [Time frame: Up to Day 85]
  • Volume of distribution (Vz) [Time frame: Up to Day 85]
  • Immunogenicity: incidence of anti-drug antibodies (ADA) [Time frame: Up to Day 85]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07576608 · 9MW3811-CP201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗