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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firsekibart injection | Experimental | Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firsekibart injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingli Dong, Professor | Contact | 0086-027-83665519 | tjhdongll@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tong ji Medical Colledge | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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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 |