Diffuse systemic sclerosis
Conditions
Interventions
Treatment group:Vunakizumab
Sponsors
The Second Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to =3 in mRSS at screening from an assessment performed within the previous 1-6 months; 2) an increase of >=2 mRSS for one lesion newly detected at screening compared with an assessment performed within the previous 1-6 months; 3) two newly identified lesions with an increase in mRSS of >=1 at screening compared with an assessment performed within the previous 1-6 months. 5. Enrolled patients had negative R-interferon release assays or T-SPOT tests at screening and chest CT without evidence of tuberculosis.
Exclusion criteria
Exclusion criteria: 1.Any of the following concomitant diseases: (1) Type 1 diabetes; (2) Poor control of type 2 diabetes (HbA1c>8.5%); (3) Congestive heart failure; (4) Heart function NYHA score II to IV; (5) Myocardial infarction, unstable angina, or stroke that occurred within the 12 months prior to enrollment; (6) Poor control of hypertension (systolic blood pressure>150 mmHg or diastolic blood pressure>90 mmHg during screening); (7) History of inflammatory bowel disease or other persistent autoimmune diseases; (8) Multiple sclerosis or other demyelinating diseases; (9) Active malignant tumors or malignant tumors that have been diagnosed or treated within the past 5 years prior to informed consent (excluding resected or surgically cured epithelial cervical cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or ductal carcinoma of the breast); (10) There are other serious diseases or comorbidities, and the researcher or associate researcher believes that the patient does not qualify for the study. 2.During screening, if any virus detection item (HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, HTLV-1 antibody) is positive, with the exception of HBc antibody and/or HBs positive and HBV-DNA testing below detection sensitivity, participants can participate in the study, but further HBV-DNA testing is required every 4 weeks. 3.Active systemic infections (excluding upper respiratory tract infections) within the two weeks prior to enrollment, or severe infections requiring oral and/or intravenous antibiotic treatment within the eight weeks prior to enrollment. 4.A history of receiving any other anti-IL-17 biologics (such as sukinumab, ixekizumab, brodalumab), and a history of receiving any other biologics and jak inhibitors within 4 months (or >= 5 half lives) prior to enrollment. 5.Patients with a history of oral corticosteroid use (methylprednisolone>15 mg/d) who have changed the dosage of oral corticosteroids within 14 days before enrollment or started oral corticosteroid treatment within 14 days are not allowed to change the glucocorticoid treatment regimen after enrollment; Medication history of receiving any of the following drugs or therapies within 28 days prior to enrollment: anti fibrotic drugs (pirfenidone, nintedanib), immunosuppressants (cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, imidacloprid, methotrexate), high-dose IVIG, imatinib, D-penicillamine, and phototherapy (UVA) therapy. 6.Abnormal laboratory test results during screening (AST >= 40 U/L or ALT >= 50 U/L); Serum total bilirubin >=25.7 µ mol/L; Hemoglobin level= 133.0 µ mol/L); 7.Women who are pregnant, breastfeeding, or planning to become pregnant. 8.History or evidence of mental illness or alcohol/drug abuse; 9.According to the Colombian Suicide Severity Rating Scale (C-SSSRS) assessment during enrollment screening and baseline assessment, there is a history of depression and/or suicidal ideation or any suicidal behavior. If any answer in the survey questionnaire is "yes", or if the researcher clinically determines that the subject is at risk of suicide, the subject will be excluded. 10.Or due to reasons other than those mentioned above, the researcher or associate researcher believes that the patient is not eligible for the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function;Rodnan skin score; | — |
Countries
China
Contacts
Public ContactRong Xiao
The Second Xiangya Hospital, Central South University
Outcome results
None listed