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临床试验 NCT07502105 针对系统性硬皮病目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis 30 开放性试验
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临床试验NCT07502105是一项针对系统性硬皮病的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月2日开始，预计招募30名患者。该研究由Tongji Hospital主导，计划于2028年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月30日。
简要概括
This study is a single-center, single-arm, open-label, exploratory clinical trial. A total of 30 patients with diffuse cutaneous systemic sclerosis (dcSSc) will be enrolled. A historical control cohort will be established to evaluate the efficacy and safety of Firsekibart by comparing with historical data.
官方标题
A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
疾病
系统性硬皮病其他研究标识符
- TJ-IRB202601060
NCT编号
实际开始日期
2026-03-02
最近更新发布
2026-03-30
预计完成日期
2028-12-01
计划入组人数
30
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Systemic Scleroderma
SSc
SSc
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Firsekibart injection Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8. | Firsekibart injection Firsekibart, independently developed by GeneScience, was officially approved for marketing by the NMPA in July 2025 as China's first domestically developed fully human monoclonal antibody targeting IL-1β. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in the modified Rodnan Skin Score (mRSS) from baseline | The mRSS is independently assessed by two physicians, evaluating the thickness of skin in 17 anatomic areas rated from 0 to 3, with a total score ranging from 0 to 51. | Week 12 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in modified Rodnan skin score (mRSS) from baseline | The mRSS is independently assessed by two physicians, evaluating the thickness of skin in 17 anatomic areas rated from 0 to 3, with a total score ranging from 0 to 51. | Week 16, 24 |
Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline | CRISS is a weighted score and includes five core set measures: modified Rodnan skin score, FVC% predicted, health assessment questionnaire-disability index, and patient and clinician global assessments. | Week 12, 16, 24 |
Change from baseline in pulmonary function (FVC) | Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled after the deepest possible breath. | Week 12, 16, 24 |
Change from baseline in pulmonary function (DLCO) | Diffusing capacity of the lungs for carbon monoxide (DLCO)is a key measure of gas diffusion across the alveolar-capillary membrane, determined by the single-breath method. | Week 12, 16, 24 |
Change in serum IL-1β levels from baseline | IL-1β plays an important role in inflammation and fibrosis, and its expression is aberrantly regulated in various autoimmune diseases. IL-1β is considered an effective target for diseases associated with fibrosis and tissue remodeling. | Week 12, 16, 24 |
Change in serum IL-6 levels from baseline | IL-1β acts as a potent upstream stimulus for IL-6 production. IL-6 activates fibroblasts, promoting their proliferation and driving the abundant synthesis of collagen and extracellular matrix components. In parallel, IL-6 induces endothelial-to-mesenchymal transition in endothelial cells, thereby exacerbating the vicious cycle between microvascular pathology and fibrosis. | Week 12, 16, 24 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Age 18-70 years (inclusive), male or female.
- Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR diagnostic criteria.
- Disease duration of diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy & Medsger (2001), of ≤ 5 years (from the time of first onset of non-Raynaud's phenomenon).
- Modified Rodnan skin score (mRSS) ≥10;
- Voluntarily signed informed consent form and ability to comply with the requirements of the study protocol.
- Allergy to the active ingredient of Firsekibart or any of its excipients, or a history of allergy to monoclonal antibodies.
- Presence of any rheumatic disease other than SSc.
- Moderate to severe lung disease with FVC < 60% or DLCO < 50% of predicted value.
- Use of medications that may interfere with the evaluation of the efficacy and safety of Firsekibart, except for stable use of permitted concomitant therapies that have been maintained for at least 4 weeks prior to screening and are kept at a stable dose throughout the study period.
- Use of biological agents or stem cell therapy within 3 months prior to screening or within 5 half-lives of the known drug.
- Receipt of live or attenuated vaccines within two months prior to screening.
- Severe hepatic impairment, renal impairment, or hematologic abnormalities at screening.
- Acute or chronic infection (excluding infection complicated by finger ulceration), active infection, history of malignant tumor, or immunodeficiency disorder.
- Women who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period.
- Any other conditions that, in the investigator's judgment, render the subject ineligible for this trial.
Tongji Hospital研究责任方
Lingli Dong, 主要研究者, professor; professor of medicine, Tongji Hospital
研究中心联系人
联系人: Lingli Dong, Professor, 0086-027-83665519, [email protected]
1 位于 1 个国家/地区的研究中心
Hubei
Tongji Hospital, Tong ji Medical Colledge, Wuhan, Hubei, 430000, China
Lingli Dong, Professor, 联系人, 0086-027-83665519, [email protected]