Stable Systemic sclerosis
Conditions
Interventions
Low /Medium/High dose group:SKLB-V02 recombinant protein Formulation
Sponsors
Department of Rheumatology and Immunology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria: (1) Voluntarily sign the informed consent form, understand and be able to complete the trial according to the protocol; (2) Aged 18-70 years old (inclusive), male or female; (3) Study participants meet the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria and are diagnosed with diffuse systemic sclerosis; (4) Interstitial lung disease (ILD) confirmed by high-resolution lung CT (HRCT) within 6 months before screening; (5) FVC during the screening period >=40% of the predicted value; (6) DLCO (corrected by hemoglobin) during the screening period >=40% of the predicted value; (7) SSc course during the screening period =< 60 months (course is defined as the time from the first manifestation of non-Raynaud's phenomenon to the screening period); (8) Skin thickening of SSc-ILD subjects does not involve the injection site of the trial drug; (9) SSc-ILD subjects can receive one of the drugs, mycophenolate mofetil/sodium or methotrexate, and both must maintain a stable dose within 3 months before the first dose, and agree to maintain a stable dose for at least 6 months after the first dose; (10) Subjects of childbearing age who have no pregnancy or sperm/egg donation plan during the trial and within 6 months after the last dose, and agree to take prescribed reliable contraceptive measures (except for subjects or partners who are infertile).
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible for inclusion: 1. Acute exacerbation of SSc 4 weeks before screening or during the screening period; 2. Combination with other rheumatic and autoimmune diseases, including but not limited to idiopathic inflammatory myopathy, systemic lupus erythematosus, primary Sjögren's syndrome, mixed connective tissue disease, systemic vasculitis, Crohn's disease, ulcerative colitis, etc; 3. Oral corticosteroids > 10 mg/day prednisone or equivalent, hydroxychloroquine > 400 mg/day, methotrexate > 25 mg/week, mycophenolate mofetil > 2 g/day (can accept combined treatment with hydroxychloroquine and methotrexate or hydroxychloroquine and mycophenolate mofetil, and must receive stable dose treatment for at least 4 weeks before the baseline visit); 4. Drug abusers and alcoholics; 5. Cerebrovascular events within 6 months before screening, including but not limited to cerebral hemorrhage and subarachnoid hemorrhage; 6. Active viral, bacterial or fungal infection during the screening period, which cannot be controlled with appropriate anti-infection treatment; 7. Patients with a history of malignant tumors (cancer that has been confirmed to have been cured or in remission for >=5 years, except for radically resected basal cell or squamous cell skin cancer, cervical cancer in situ and resected colon polyps); 8. History of HIV and syphilis (determined by medical records or patient reports.; 9. Positive hepatitis B HBV-DNA test; Patients with hepatitis B virus (HBV) infection, currently receiving anti-HBV treatment and HBV-DNA negative can be enrolled, and HBV-DNA will be monitored during the study; 10. Positive hepatitis C test; Patients with hepatitis C virus (HCV) infection (positive hepatitis C antibody and positive HCV ribonucleic acid RNA); Note: Patients with previous HCV infection and anti-HCV treatment and HCV RNA negative can be enrolled; 11. Subjects at risk of tuberculosis (TB); (1) Participants who have a history of active TB in the past 3 years (even if they have received treatment) are specifically excluded from this study; history of active TB for more than 3 years, unless there is a record of appropriate duration and type of previous anti-TB treatment; current clinical, imaging, or laboratory evidence of active TB; 12. The presence of the following clinically significant heart diseases: (1). History of chronic congestive heart failure (NYHA IV heart function), history of echocardiogram-detected cardiac ejection fraction (EF) = 480 ms (according to Fridericia correction formula, where QTcF=QT/RR^0.33), or a history of prolonged QTc interval; 13. Received any clinical trial research drug (not on the market) or medical device treatment within 3 months or 5 half-lives (the longer of the two) before baseline; 14. Suffering from mental illness or other medical conditions, unable to c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Acute exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function test;High-resolution CT results of the chest;Scleroderma Specialist Color Doppler Ultrasound;Complete blood test;Blood biochemistry;Coagulation;Immune indicators;Electrocardiogram data;Immunoglobulins;Modified Rodnan Skin Score;Baseline Cochin Hand Function Scale;Dyspnea score (mMRC scale);Health Assessment Questionnaire Disability Index (HAQ-DI);Physician's overall assessment;Patient Global Assessment;Vital signs and physical examination;Autoimmune antibodies;ESR;Stool routine;Urinalysis;Laborary examination; | — |
Countries
China
Contacts
Public ContactQibing Xie
West China Hospital, Sichuan University
Outcome results
None listed