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NCT Number: NCT07576608

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location status: Recruiting

Location contact

Tao Zan, Professor, MD, PhD

CONTACT

[email protected]

+86 13795204523

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

9MW3811 injection

Drug

9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.

Placebo

Drug

Matching placebo solution with no active ingredient, administered intravenously.

Primary outcomes

  1. Change from baseline in modified Vancouver Scar Scale (mVSS) score

    Time frame: 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.

  2. Assessment of adverse events (AE) / serious adverse events (SAEs)

    Time frame: 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.

  3. Number of participants with abnormal vital signs

    Time frame: Up to Week 12

    Vital signs: include pulse, respiration, body temperature and blood pressure

  4. Number of participants with abnormal Physical examination findings

    Time frame: Up to Week 12

    Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites

  5. Number of participants with abnormal 12-lead ECG readings

    Time frame: Up to Week 12

    12-lead ECG: HR, PR, QRS, QT, QTcF,

  6. Number of participants with abnormal laboratory test results

    Time frame: Up to Week 12

    Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function

Secondary outcomes

  1. Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score

    Time frame: Up to Week 12

    POSAS includes observer scale (vascularity, pigmentation, thickness, relief, pliability, surface area) and patient scale (pain, itching, color, stiffness, thickness, irregularity). Lower scores indicate improvement.

  2. Change from baseline in Dermatology Life Quality Index (DLQI) score

    Time frame: Up to Week 12

    DLQI measures impact of skin disease on quality of life. Total score ranges 0-30; lower scores indicate better quality of life.

  3. Maximum Plasma Concentration (Cmax)

    Time frame: Up to Day 85

    To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.

  4. Time to reach Cmax (Tmax)

    Time frame: Up to Day 85

    To determine the PK of 9MW3811 following multiple intravenous infusions.

  5. 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

    To determine the PK of 9MW3811 following multiple intravenous infusions.

  6. Terminal elimination half-life (t1/2)

    Time frame: Up to Day 85

    To determine the PK of 9MW3811 following multiple intravenous infusions.

  7. AUC from time 0 extrapolated to infinity (AUC0-inf)

    Time frame: Up to Day 85

    To determine the PK of 9MW3811 following multiple intravenous infusions.

  8. Terminal elimination rate constant (λz)

    Time frame: Up to Day 85

    To determine the PK of 9MW3811 following multiple intravenous infusions.

  9. Apparent clearance (CL)

    Time frame: Up to Day 85

    To determine the PK of 9MW3811 following multiple intravenous infusions.

  10. Volume of distribution (Vz)

    Time frame: Up to Day 85

    To determine the PK of 9MW3811 following multiple intravenous infusions.

  11. Immunogenicity: incidence of anti-drug antibodies (ADA)

    Time frame: Up to Day 85

    Percentage of participants who develop detectable ADA against 9MW3811.

Other outcomes

  1. Change in pharmacodynamic biomarkers

    Time frame: Up to Day 85

    Change from baseline in blood levels of interleukin-11; Collect skin biopsy samples from the same scar lesion in patients before baseline assessment and on Day 85 to evaluate changes from baseline in: total collagen content and arrangement pattern, extracellular matrix components such as type I and type III collagen. and expression levels of fibroblast activation markers such as α-smooth muscle actin in the lesional tissue.

  2. Change from baseline in superficial vascularity distribution score in scar tissue

    Time frame: Up to Week 12

    Assessed using a 3D skin imaging device. The scar region is selected as the ROI (region of interest), and the device's built-in red area analysis function is used to quantify vascular distribution via feature count points and a derived score. One normal skin area adjacent to the scar serves as a control.

  3. Change from baseline in red pigment (hemoglobin) and black pigment (melanin) index in scar tissue

    Time frame: Up to Week 12

    Measured by a skin colorimeter under resting conditions. Depending on scar size, 1-4 measurement points are taken within the scar, and 2 points on adjacent normal skin. The mean value of each region is reported as the black pigment index (unit: arbitrary scale from the device).

  4. Change from baseline in skin viscoelasticity (R2 value) in scar tissue

    Time frame: Up to Week 12

    Assessed using a skin viscoelasticity meter. R2 = Ua/Uf, where Ua is the elastic-plastic deformation during retraction and Uf is the elastic-plastic deformation during stretching. R2 closer to 1 indicates better skin elasticity. Depending on scar size, 1-4 measurement points are taken within the scar and 1 point on adjacent normal skin. The mean R2 value of the scar region is reported (unit: ratio, dimensionless).

  5. Change from baseline in scar thickness measured by ultrasound

    Time frame: Up to Week 12

    Scar thickness is defined as the distance from the dermal-epidermal junction to the subcutaneous fat layer (strong collagen signal region). Ultrasound measurement is taken at the most prominent point of the scar (usually the center). The result is reported in millimeters (mm).

  6. Change from baseline in scar hardness measured by ultrasound

    Time frame: Up to Week 12

    Assessed using the tissue hardness measurement function of an ultrasound device. The scar region is defined as the dermis from the dermal-epidermal junction to the subcutaneous fat layer. Depending on scar size, 1-3 measurement points are taken within the scar, and the mean value is reported. Units are as provided by the device (e.g., kilopascals [kPa] or relative stiffness units).

Study contacts

Contact information is provided by the study sponsor or research team.

Liecheng Yang

CONTACT

[email protected]

021-58585793

Sponsors and collaborators

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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