A Phase II Study of 9MW3811 in Patients With Pathological Scar
30. april 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Liecheng Yang
- Telefonnummer: 021-58585793
- E-post: liecheng.yang@mabwell.com
Studiesteder
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200011
- Rekruttering
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
-
Ta kontakt med:
- Tao Zan, Professor, MD, PhD
- Telefonnummer: +86 13795204523
- E-post: zantao@sjtu.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 9MW3811 Injection (Low Dose)
Intravenous infusion, multiple doses administered according to the protocol
|
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
|
|
Eksperimentell: 9MW3811 Injection (Middle Dose)
Intravenous infusion, multiple doses administered according to the protocol
|
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
|
|
Eksperimentell: 9MW3811 Injection (High Dose)
Intravenous infusion, multiple doses administered according to the protocol
|
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
|
|
Placebo komparator: Placebo
Intravenous infusion, matching placebo administered on the same schedule
|
Matching placebo solution with no active ingredient, administered intravenously.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in modified Vancouver Scar Scale (mVSS) score
Tidsramme: 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
|
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Assessment of adverse events (AE) / serious adverse events (SAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to Week 12
|
12-lead ECG: HR, PR, QRS, QT, QTcF,
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Up to Week 12
|
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Number of participants with abnormal laboratory test results
Tidsramme: Up to Week 12
|
Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
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Up to Week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
Tidsramme: 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
Tidsramme: 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.
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Up to Week 12
|
|
Maximum Plasma Concentration (Cmax)
Tidsramme: Up to Day 85
|
To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.
|
Up to Day 85
|
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Time to reach Cmax (Tmax)
Tidsramme: Up to Day 85
|
To determine the PK of 9MW3811 following multiple intravenous infusions.
|
Up to Day 85
|
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Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Tidsramme: Up to Day 85
|
To determine the PK of 9MW3811 following multiple intravenous infusions.
|
Up to Day 85
|
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Terminal elimination half-life (t1/2)
Tidsramme: Up to Day 85
|
To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
|
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AUC from time 0 extrapolated to infinity (AUC0-inf)
Tidsramme: Up to Day 85
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To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
|
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Terminal elimination rate constant (λz)
Tidsramme: Up to Day 85
|
To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
|
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Apparent clearance (CL)
Tidsramme: Up to Day 85
|
To determine the PK of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
|
|
Volume of distribution (Vz)
Tidsramme: Up to Day 85
|
To determine the PK of 9MW3811 following multiple intravenous infusions.
|
Up to Day 85
|
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Immunogenicity: incidence of anti-drug antibodies (ADA)
Tidsramme: Up to Day 85
|
Percentage of participants who develop detectable ADA against 9MW3811.
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Up to Day 85
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in pharmacodynamic biomarkers
Tidsramme: 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.
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Up to Day 85
|
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Change from baseline in superficial vascularity distribution score in scar tissue
Tidsramme: 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
|
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Change from baseline in red pigment (hemoglobin) and black pigment (melanin) index in scar tissue
Tidsramme: 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).
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Up to Week 12
|
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Change from baseline in skin viscoelasticity (R2 value) in scar tissue
Tidsramme: 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).
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Up to Week 12
|
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Change from baseline in scar thickness measured by ultrasound
Tidsramme: 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
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. desember 2025
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
12. april 2026
Først innsendt som oppfylte QC-kriteriene
30. april 2026
Først lagt ut (Faktiske)
8. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 9MW3811-CP201
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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