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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Scar
• Intervention / Treatment: Drug: 9MW3811 Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liecheng Yang; Phone Number: 021-58585793; Email: liecheng.yang@mabwell.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Recruiting
      • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Tao Zan, Professor, MD, PhD; Phone Number: +86 13795204523; Email: zantao@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9MW3811 Injection (Low Dose); Intravenous infusion, multiple doses administered according to the protocol	Drug: 9MW3811 Injection; 9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Experimental: 9MW3811 Injection (Middle Dose); Intravenous infusion, multiple doses administered according to the protocol	Drug: 9MW3811 Injection; 9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Experimental: 9MW3811 Injection (High Dose); Intravenous infusion, multiple doses administered according to the protocol	Drug: 9MW3811 Injection; 9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Placebo Comparator: Placebo; Intravenous infusion, matching placebo administered on the same schedule	Drug: Placebo; Matching placebo solution with no active ingredient, administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in modified Vancouver Scar Scale (mVSS) score	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.	Up to Week 12
Assessment of adverse events (AE) / serious adverse events (SAEs)	Adverse Events occurring from ICF to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 6.0.	Up to Week 12
Number of participants with abnormal vital signs	Vital signs: include pulse, respiration, body temperature and blood pressure	Up to Week 12
Number of participants with abnormal Physical examination findings	Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites	Up to Week 12
Number of participants with abnormal 12-lead ECG readings	12-lead ECG: HR, PR, QRS, QT, QTcF,	Up to Week 12
Number of participants with abnormal laboratory test results	Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function	Up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score	POSAS includes observer scale (vascularity, pigmentation, thickness, relief, pliability, surface area) and patient scale (pain, itching, color, stiffness, thickness, irregularity). Lower scores indicate improvement.	Up to Week 12
Change from baseline in Dermatology Life Quality Index (DLQI) score	DLQI measures impact of skin disease on quality of life. Total score ranges 0-30; lower scores indicate better quality of life.	Up to Week 12
Maximum Plasma Concentration (Cmax)	To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.	Up to Day 85
Time to reach Cmax (Tmax)	To determine the PK of 9MW3811 following multiple intravenous infusions.	Up to Day 85
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)	To determine the PK of 9MW3811 following multiple intravenous infusions.	Up to Day 85
Terminal elimination half-life (t1/2)	To determine the PK of 9MW3811 following multiple intravenous infusions.	Up to Day 85
AUC from time 0 extrapolated to infinity (AUC0-inf)	To determine the PK of 9MW3811 following multiple intravenous infusions.	Up to Day 85
Terminal elimination rate constant (λz)	To determine the PK of 9MW3811 following multiple intravenous infusions.	Up to Day 85
Apparent clearance (CL)	To determine the PK of 9MW3811 following multiple intravenous infusions.	Up to Day 85
Volume of distribution (Vz)	To determine the PK of 9MW3811 following multiple intravenous infusions.	Up to Day 85
Immunogenicity: incidence of anti-drug antibodies (ADA)	Percentage of participants who develop detectable ADA against 9MW3811.	Up to Day 85

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pharmacodynamic biomarkers	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.	Up to Day 85
Change from baseline in superficial vascularity distribution score in scar tissue	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.	Up to Week 12
Change from baseline in red pigment (hemoglobin) and black pigment (melanin) index in scar tissue	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).	Up to Week 12
Change from baseline in skin viscoelasticity (R2 value) in scar tissue	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).	Up to Week 12
Change from baseline in scar thickness measured by ultrasound	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).	Up to Week 12
Change from baseline in scar hardness measured by ultrasound	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).	Up to Week 12

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Pathological Conditions, Signs and Symptoms; Cicatrix
• Other Study ID Numbers: 9MW3811-CP201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No