Scar
Conditions
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.
Interventions
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
DRUGPlacebo
Matching placebo solution with no active ingredient, administered intravenously.
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal vital signs | Up to Week 12 | Vital signs: include pulse, respiration, body temperature and blood pressure |
| Number of participants with abnormal Physical examination findings | Up to Week 12 | Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites |
| Number of participants with abnormal 12-lead ECG readings | Up to Week 12 | 12-lead ECG: HR, PR, QRS, QT, QTcF, |
| Number of participants with abnormal laboratory test results | Up to Week 12 | Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function |
| Change from baseline in modified Vancouver Scar Scale (mVSS) score | 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. |
| Assessment of adverse events (AE) / serious adverse events (SAEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent clearance (CL) | Up to Day 85 | To determine the PK of 9MW3811 following multiple intravenous infusions. |
| Volume of distribution (Vz) | Up to Day 85 | To determine the PK of 9MW3811 following multiple intravenous infusions. |
| Immunogenicity: incidence of anti-drug antibodies (ADA) | Up to Day 85 | Percentage of participants who develop detectable ADA against 9MW3811. |
| Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score | 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. |
| Maximum Plasma Concentration (Cmax) | Up to Day 85 | To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions. |
| Change from baseline in Dermatology Life Quality Index (DLQI) score | 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. |
| Time to reach Cmax (Tmax) | Up to Day 85 | To determine the PK of 9MW3811 following multiple intravenous infusions. |
| Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) | Up to Day 85 | To determine the PK of 9MW3811 following multiple intravenous infusions. |
| Terminal elimination half-life (t1/2) | Up to Day 85 | To determine the PK of 9MW3811 following multiple intravenous infusions. |
| AUC from time 0 extrapolated to infinity (AUC0-inf) | Up to Day 85 | To determine the PK of 9MW3811 following multiple intravenous infusions. |
| Terminal elimination rate constant (λz) | Up to Day 85 | To determine the PK of 9MW3811 following multiple intravenous infusions. |
Countries
China
Contacts
CONTACTLiecheng Yang
Outcome results
None listed