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

NCT07576608 | Recruiting Phase 2

• 1 other identifier: 9MW3811-CP201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Scar

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

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

  Up to Week 12

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

  Up to Week 12

• Maximum Plasma Concentration (Cmax)

  Up to Day 85

• Time to reach Cmax (Tmax)

  Up to Day 85

• Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)

  Up to Day 85

Other Outcomes (6)

• Change in pharmacodynamic biomarkers

  Up to Day 85

• Change from baseline in superficial vascularity distribution score in scar tissue

  Up to Week 12

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

  Up to Week 12

Study Arms (4)

9MW3811 Injection (Low Dose)

EXPERIMENTAL

Intravenous infusion, multiple doses administered according to the protocol

Drug: 9MW3811 Injection

9MW3811 Injection (Middle Dose)

EXPERIMENTAL

Intravenous infusion, multiple doses administered according to the protocol

Drug: 9MW3811 Injection

9MW3811 Injection (High Dose)

EXPERIMENTAL

Intravenous infusion, multiple doses administered according to the protocol

Drug: 9MW3811 Injection

Placebo

PLACEBO COMPARATOR

Intravenous infusion, matching placebo administered on the same schedule

Drug: Placebo

Interventions

9MW3811 Injection DRUG

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

9MW3811 Injection (High Dose); 9MW3811 Injection (Low Dose); 9MW3811 Injection (Middle Dose)

Placebo DRUG

Matching placebo solution with no active ingredient, administered intravenously.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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

Sponsors & Collaborators

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

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liecheng Yang

CONTACT

021-58585793; liecheng.yang@mabwell.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 8, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)