A Phase II Study of 9MW3811 in Patients With Pathological Scar
2026년 4월 30일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
30
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Liecheng Yang
- 전화번호: 021-58585793
- 이메일: liecheng.yang@mabwell.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200011
- 모병
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
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연락하다:
- Tao Zan, Professor, MD, PhD
- 전화번호: +86 13795204523
- 이메일: zantao@sjtu.edu.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 9MW3811 Injection (Low Dose)
Intravenous infusion, multiple doses administered according to the protocol
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9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
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실험적: 9MW3811 Injection (Middle Dose)
Intravenous infusion, multiple doses administered according to the protocol
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9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
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실험적: 9MW3811 Injection (High Dose)
Intravenous infusion, multiple doses administered according to the protocol
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9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11).
It is administered intravenously.
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위약 비교기: Placebo
Intravenous infusion, matching placebo administered on the same schedule
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Matching placebo solution with no active ingredient, administered intravenously.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in modified Vancouver Scar Scale (mVSS) score
기간: Up to Week 12
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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.
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Up to Week 12
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Assessment of adverse events (AE) / serious adverse events (SAEs)
기간: Up to Week 12
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Adverse Events occurring from ICF to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 6.0.
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Up to Week 12
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Number of participants with abnormal vital signs
기간: Up to Week 12
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Vital signs: include pulse, respiration, body temperature and blood pressure
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Up to Week 12
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Number of participants with abnormal Physical examination findings
기간: Up to Week 12
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Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
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Up to Week 12
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Number of participants with abnormal 12-lead ECG readings
기간: Up to Week 12
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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
기간: Up to Week 12
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Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
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Up to Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
기간: Up to Week 12
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POSAS includes observer scale (vascularity, pigmentation, thickness, relief, pliability, surface area) and patient scale (pain, itching, color, stiffness, thickness, irregularity).
Lower scores indicate improvement.
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Up to Week 12
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Change from baseline in Dermatology Life Quality Index (DLQI) score
기간: Up to Week 12
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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
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Maximum Plasma Concentration (Cmax)
기간: Up to Day 85
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To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.
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Up to Day 85
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Time to reach Cmax (Tmax)
기간: 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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Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
기간: 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 half-life (t1/2)
기간: 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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AUC from time 0 extrapolated to infinity (AUC0-inf)
기간: 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)
기간: 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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Apparent clearance (CL)
기간: 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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Volume of distribution (Vz)
기간: 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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Immunogenicity: incidence of anti-drug antibodies (ADA)
기간: Up to Day 85
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Percentage of participants who develop detectable ADA against 9MW3811.
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Up to Day 85
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in pharmacodynamic biomarkers
기간: Up to Day 85
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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
기간: Up to Week 12
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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.
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Up to Week 12
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Change from baseline in red pigment (hemoglobin) and black pigment (melanin) index in scar tissue
기간: Up to Week 12
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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
기간: Up to Week 12
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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
기간: Up to Week 12
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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).
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Up to Week 12
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Change from baseline in scar hardness measured by ultrasound
기간: Up to Week 12
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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).
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Up to Week 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 12월 29일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 4월 12일
QC 기준을 충족하는 최초 제출
2026년 4월 30일
처음 게시됨 (실제)
2026년 5월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 30일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 9MW3811-CP201
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
9MW3811 Injection에 대한 임상 시험
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Mabwell (Shanghai) Bioscience Co., Ltd.모병
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Mabwell (Shanghai) Bioscience Co., Ltd.아직 모집하지 않음
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Mabwell (Shanghai) Bioscience Co., Ltd.완전한
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Marmara University모병
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China Academy of Chinese Medical SciencesNational Natural Science Foundation of China모병
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Shanghai University of Traditional Chinese Medicine아직 모집하지 않음
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Shanghai University of Traditional Chinese Medicine알려지지 않은