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

30 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200011
        • Reclutamento
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contatto:
          • Tao Zan, Professor, MD, PhD
          • Numero di telefono: +86 13795204523
          • Email: zantao@sjtu.edu.cn

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 9MW3811 Injection (Low Dose)
Intravenous infusion, multiple doses administered according to the protocol
Droga: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Sperimentale: 9MW3811 Injection (Middle Dose)
Intravenous infusion, multiple doses administered according to the protocol
Droga: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Sperimentale: 9MW3811 Injection (High Dose)
Intravenous infusion, multiple doses administered according to the protocol
Droga: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Comparatore placebo: Placebo
Intravenous infusion, matching placebo administered on the same schedule
Droga: Placebo
Matching placebo solution with no active ingredient, administered intravenously.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in modified Vancouver Scar Scale (mVSS) score
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Week 12
12-lead ECG: HR, PR, QRS, QT, QTcF,
Up to Week 12
Number of participants with abnormal laboratory test results
Lasso di tempo: Up to Week 12
Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
Up to Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Up to Day 85
To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Time to reach Cmax (Tmax)
Lasso di tempo: 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)
Lasso di tempo: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Terminal elimination half-life (t1/2)
Lasso di tempo: 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)
Lasso di tempo: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Terminal elimination rate constant (λz)
Lasso di tempo: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Apparent clearance (CL)
Lasso di tempo: Up to Day 85
To determine the PK of 9MW3811 following multiple intravenous infusions.
Up to Day 85
Volume of distribution (Vz)
Lasso di tempo: 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)
Lasso di tempo: Up to Day 85
Percentage of participants who develop detectable ADA against 9MW3811.
Up to Day 85

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in pharmacodynamic biomarkers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 dicembre 2025

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

12 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 9MW3811-CP201

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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