A Phase II Study of 9MW3811 in Patients With Pathological Scar
2026年4月30日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Liecheng Yang
- 電話番号：021-58585793
- メール：liecheng.yang@mabwell.com
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200011
- 募集
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
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コンタクト：
- Tao Zan, Professor, MD, PhD
- 電話番号：+86 13795204523
- メール：zantao@sjtu.edu.cn
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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実験的：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.
|
|
実験的：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.
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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in modified Vancouver Scar Scale (mVSS) score
時間枠：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.
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Up to Week 12
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Assessment of adverse events (AE) / serious adverse events (SAEs)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pharmacodynamic biomarkers
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年12月29日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年4月12日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月8日
QC基準を満たした最後の更新が送信されました
2026年4月30日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 9MW3811-CP201
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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