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

30 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200011
        • Recrutement
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Tao Zan, Professor, MD, PhD
          • Numéro de téléphone: +86 13795204523
          • E-mail: zantao@sjtu.edu.cn

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 9MW3811 Injection (Low Dose)
Intravenous infusion, multiple doses administered according to the protocol
Médicament: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Expérimental: 9MW3811 Injection (Middle Dose)
Intravenous infusion, multiple doses administered according to the protocol
Médicament: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Expérimental: 9MW3811 Injection (High Dose)
Intravenous infusion, multiple doses administered according to the protocol
Médicament: 9MW3811 Injection
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
Comparateur placebo: Placebo
Intravenous infusion, matching placebo administered on the same schedule
Médicament: Placebo
Matching placebo solution with no active ingredient, administered intravenously.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in modified Vancouver Scar Scale (mVSS) score
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: Up to Week 12
12-lead ECG: HR, PR, QRS, QT, QTcF,
Up to Week 12
Number of participants with abnormal laboratory test results
Délai: Up to Week 12
Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
Up to Week 12

Mesures de résultats secondaires

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in pharmacodynamic biomarkers
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Mabwell (Shanghai) Bioscience Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 décembre 2025

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

12 avril 2026

Première soumission répondant aux critères de contrôle qualité

30 avril 2026

Première publication (Réel)

8 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 9MW3811-CP201

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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