Systemic sclerosis
Conditions
Interventions
experimental group:Subcutaneous injection of Firsekibart 200 mg once every 4 weeks for 24 weeks (a total of 6 administrations).
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form, aged between 18 and 70 years old, regardless of gender; 2. Meet the classification criteria for systemic sclerosis established by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2013; 3. Inadequate response to prior therapy (poor efficacy or intolerance with continuous use for at least three months), with current disease progression as determined by the investigator, including but not limited to (progression of skin involvement, worsening gastrointestinal involvement, progressive pulmonary fibrosis, worsening vasculopathy of Raynaud's phenomenon, or uncontrolled pulmonary arterial hypertension). 4. If glucocorticoids are used during the screening period, the dosage should be stable (=4 weeks; if immunosuppressants (such as mycophenolate mofetil, methotrexate, azathioprine) are used, the dosage should be stable for =8 weeks.
Exclusion criteria
Exclusion criteria: 1. Severe organ dysfunction: a) Severe heart disease (LVEF < 40%, NYHA cardiac function class III - IV, history of unstable angina or myocardial infarction within 6 months); b) Renal insufficiency (eGFR < 30 ml/min/1.73m²). 2. Active infection (e.g., uncontrolled HBV, HCV, or HIV infection, positive T - SPOT test for tuberculosis infection or imaging suggesting active tuberculosis), or severe infection requiring hospitalization or intravenous antibiotic treatment within 4 weeks before screening. 3. History of or current malignancy (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). 4. Pregnant or lactating women, or those planning to become pregnant and unwilling to take effective contraceptive measures. 5. History of allergy to the study drug or any of its excipients. 6. Any other unstable or poorly - controlled diseases that, in the judgment of the investigator, make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with baseline mRSS>20 were evaluated by CRISS score at 24 weeks. Patients with baseline mRSSS=20, an increase in lung function DLCO >15% or an increase in FVC >10% of the predicted value, combined; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRISS score at week 48;Assessment of improvement in interstitial lung disease at week 48, Lung function DLCO increase >15% or FVC increase >10% predicted value, combined with chest HRCT;Systemic Sclerosis Clinical Trials Consortium Impairment Index (SCTC-DI) at week 24 and week 48;Skin improvement assessment at week 24 and week 48: baseline >20, mRSS decreased >25% compared with baseline; Baseline mRSS=20, mRSS score decline =5 points;Biomarkers(Blood, tissue)); | — |
Countries
China
Contacts
Public ContactQing Yufeng
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed