Stable diffuse systemic sclerosis
Conditions
Interventions
Experimental Group:FIBVax preparation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18–70 years. 2) The study participant has signed the informed consent form, understands the purpose, procedures, and content of the study, and voluntarily agrees to participate. 3) The study participant meets the 2013 American College of Rheumatology / European League Against Rheumatism (ACR/EULAR) classification criteria for systemic sclerosis and is diagnosed with diffuse cutaneous systemic sclerosis. 4) Within 6 months prior to screening, high-resolution computed tomography (HRCT) of the lung clearly confirms the diagnosis of interstitial lung disease (ILD). 5) Modified Rodnan skin score (mRSS) >=5. 6) Participants receiving background therapy with pirfenidone or nintedanib must have been on a stable antifibrotic regimen for more than 12 weeks prior to the visit. 7) Oral corticosteroids (=2 weeks prior to and including the baseline visit. 8) If receiving oral background therapy with methotrexate (>=7.5 mg/week) or mycophenolate mofetil (>=1.0 g/day), the dose must be stable for at least 12 weeks. 9) PDE-5 inhibitors and/or endothelin receptor antagonists are permitted as oral treatment for Raynaud’s phenomenon, digital ulcers, or pulmonary arterial hypertension. 10) Adequate organ function: within 7 days before starting treatment, routine blood tests, liver and kidney function, and coagulation laboratory results must meet the following criteria: white blood cell count (WBC) >= 3.5×10^9/L, platelet count (PLT) >= 80×10^9/L, absolute neutrophil count (ANC) >= 1.5×10^9/L, hemoglobin (HGB) >= 90 g/L, aspartate aminotransferase (AST) < 2.5× upper limit of normal (ULN) (<5×ULN in patients with liver metastases), alanine aminotransferase (ALT) < 2.5×ULN (<5×ULN in patients with liver metastases), total bilirubin (TIBC) < 1.5×ULN, serum creatinine (CR) < 1.0×ULN, and prothrombin time, partial thromboplastin time, plasma fibrinogen, and thrombin time within normal range.
Exclusion criteria
Exclusion criteria: 1) Acute exacerbation of SSc within 4 weeks prior to screening or during the screening period. 2) Presence of other connective tissue diseases, including but not limited to: systemic lupus erythematosus, inflammatory myopathy, vasculitis, rheumatoid arthritis, eosinophilic fasciitis, etc. 3) Oral corticosteroids > 10 mg/day prednisone or equivalent, hydroxychloroquine > 400 mg/day, methotrexate > 25 mg/week, mycophenolate mofetil > 2 g/day (combination therapy of hydroxychloroquine and methotrexate or hydroxychloroquine and mycophenolate mofetil is acceptable, provided that the patient has been on a stable dose regimen for at least 4 weeks prior to the baseline visit). 4) Drug abuse or alcohol addiction. 5) History of cerebrovascular events (including but not limited to cerebral hemorrhage, subarachnoid hemorrhage) within 6 months prior to screening. 6) Active viral, bacterial, or fungal infection during the screening period that cannot be controlled with appropriate anti-infective therapy. 7) History of malignancy (except for cancers that have been cured or in remission for >=5 years, radically resected basal cell or squamous cell skin cancer, in situ cervical cancer, and resected colonic polyps). 8) History of HIV infection or syphilis (as determined by medical records or patient report). 9) Positive HBV-DNA test for hepatitis B. Patients with hepatitis B virus (HBV) infection who are receiving anti-HBV therapy and have negative HBV-DNA may be enrolled; HBV-DNA will be monitored during the study. 10) Positive hepatitis C test. Patients with hepatitis C virus (HCV) infection (positive HCV antibody and positive HCV RNA). Note: Patients with documented past HCV infection who have received anti-HCV therapy and have negative HCV RNA may be enrolled. 11) Subjects at risk for tuberculosis (TB): specifically excluded are participants with a history of active TB within the past 3 years (even if treated); active TB history more than 3 years unless there is documented evidence of appropriate duration and type of prior anti-TB therapy; current clinical, radiographic, or laboratory evidence of active TB. 12) Presence of clinically significant cardiac disease, including: a) History of chronic congestive heart failure (NYHA class IV), history of echocardiographically documented ejection fraction (EF) =480 ms (Fridericia correction formula: QTcF = QT/RR^0.33), or history of prolonged QTc interval. 13) Receipt of any investigational drug (unapproved) or medical device treatment in any clinical trial within 3 months or 5 half-lives (whichever is longer) prior to baseline. 14) Known hypersensitivity to any component of the immunomodulatory agent. 15) Vaccination with other live vaccines within the past 12 weeks, or expected need/receipt of live vaccines during the study; COVID-19 vaccination within 2 weeks prior to screening. 16) Prior receipt of stem cell therapy or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom Assessment;Vital signs and physical examination;Specialized color Doppler ultrasound for scleroderma;Pulmonary function test;High-resolution chest CT scan;Laboratory examination; | — |
Countries
China
Contacts
Public ContactQibing Xie
West China Hospital, Sichuan University
Outcome results
None listed