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

30 april 2026 bijgewerkt door: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200011
        • Werving
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 9MW3811 Injection (Low Dose)
Intravenous infusion, multiple doses administered according to the protocol
Geneesmiddel: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Experimenteel: 9MW3811 Injection (Middle Dose)
Intravenous infusion, multiple doses administered according to the protocol
Geneesmiddel: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Experimenteel: 9MW3811 Injection (High Dose)
Intravenous infusion, multiple doses administered according to the protocol
Geneesmiddel: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Placebo-vergelijker: Placebo
Intravenous infusion, matching placebo administered on the same schedule
Geneesmiddel: Placebo
Matching placebo solution with no active ingredient, administered intravenously.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in modified Vancouver Scar Scale (mVSS) score
Tijdsspanne: 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.
Up to Week 12
Assessment of adverse events (AE) / serious adverse events (SAEs)
Tijdsspanne: 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.
Up to Week 12
Number of participants with abnormal vital signs
Tijdsspanne: Up to Week 12
Vital signs: include pulse, respiration, body temperature and blood pressure
Up to Week 12
Number of participants with abnormal Physical examination findings
Tijdsspanne: Up to Week 12
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
Tijdsspanne: Up to Week 12
12-lead ECG: HR, PR, QRS, QT, QTcF,
Up to Week 12
Number of participants with abnormal laboratory test results
Tijdsspanne: Up to Week 12
Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
Up to Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
Tijdsspanne: 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.
Up to Week 12
Change from baseline in Dermatology Life Quality Index (DLQI) score
Tijdsspanne: 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.
Up to Week 12
Maximum Plasma Concentration (Cmax)
Tijdsspanne: Up to Day 85
To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Time to reach Cmax (Tmax)
Tijdsspanne: Up to Day 85
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)
Tijdsspanne: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Terminal elimination half-life (t1/2)
Tijdsspanne: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
AUC from time 0 extrapolated to infinity (AUC0-inf)
Tijdsspanne: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Terminal elimination rate constant (λz)
Tijdsspanne: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Apparent clearance (CL)
Tijdsspanne: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Volume of distribution (Vz)
Tijdsspanne: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Immunogenicity: incidence of anti-drug antibodies (ADA)
Tijdsspanne: Up to Day 85
Percentage of participants who develop detectable ADA against 9MW3811.
Up to Day 85

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in pharmacodynamic biomarkers
Tijdsspanne: 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.
Up to Day 85
Change from baseline in superficial vascularity distribution score in scar tissue
Tijdsspanne: 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.
Up to Week 12
Change from baseline in red pigment (hemoglobin) and black pigment (melanin) index in scar tissue
Tijdsspanne: 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).
Up to Week 12
Change from baseline in skin viscoelasticity (R2 value) in scar tissue
Tijdsspanne: 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).
Up to Week 12
Change from baseline in scar thickness measured by ultrasound
Tijdsspanne: 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).
Up to Week 12
Change from baseline in scar hardness measured by ultrasound
Tijdsspanne: 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).
Up to Week 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 december 2025

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

12 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 april 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

30 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 9MW3811-CP201

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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