Systemic Lupus Erythematosus
Conditions
Interventions
Treatment Arm (Telitacicept):Telitacicept combined with standard therapy: Telitacicept 80 mg administered subcutaneously once weekly for up to 52 weeks or until treatment failure. Throughout the study
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older, male or female; 2.Patients who meet the 2019 EULAR/ACR classification criteria and are definitively diagnosed with SLE; 3.Required glucocorticoid dose (prednisone or equivalent) for disease control is >5 mg/day and =12 weeks, defined as a sustained SLEDAI-2k score of no more than 6, with no BILAG A score and a maximum of one BILAG B score; 5.Stable treatment regimen with hydroxychloroquine and immunosuppressants/immunomodulators for at least 30 days prior to enrollment; 6.Voluntary participation in this study and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational drug; 2. Severe involvement of vital organs within the past 24 weeks, including lupus encephalopathy, diffuse alveolar hemorrhage, thrombotic thrombocytopenic purpura, rapidly progressive glomerulonephritis, severe thrombocytopenia, severe hemolytic anemia, cardiac involvement, myelitis, or severe peripheral neuropathy; 3. History of other autoimmune diseases, such as systemic sclerosis (with the exception of secondary Sjögren's syndrome); 4. History of malignancy within the past 5 years; 5. Pregnant or lactating women, or men or women planning to have children during the trial period; 6. Patients with psychiatric disorders or lack of capacity for civil conduct; 7.Presence of central nervous system diseases related to SLE or non-SLE within 8 weeks prior to enrollment; 8.Presence of infection within 1 week prior to enrollment, or hematological results suggesting significant infection; 9.Active infection at screening (e.g., hepatitis B defined as HBsAg positive, hepatitis C, HIV, tuberculosis, etc.); 10.Hypogammaglobulinemia (IgG < 400 mg/dL) or IgA deficiency (IgA < 10 mg/dL); 11.Treatment with cyclophosphamide, rituximab, belimumab, or other B-cell targeted therapies within 6 months prior to enrollment; 12.Intravenous immunoglobulin (IVIG) therapy within 28 days prior to enrollment; 13.Administration of any live vaccine within 28 days prior to enrollment; 14.Participation in any other clinical trial within 28 days prior to enrollment, or within 5 half-lives of the investigational drug from a previous trial; 15.Any other condition considered by the investigator as unsuitable for participation or potentially posing significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who reached the low disease activity state (LLDAS 5) in the 52nd week and whose glucocorticoid (prednisone or equivalent dose) was = 5 mg/day in the 48th to 52nd weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Flare rate within 52 weeks, including mild-moderate flares and severe flares (assessed using the revised SLE Flare Index [SFI]); time to first flare;Proportion of patients achieving Lupus Low Disease Activity State (LLDAS) with glucocorticoid dose =5 mg/day at Week 24, and proportion of patients achieving LLDAS with glucocorticoid dose =7.5 mg/day at Week 24 and Week 52, respectively.;Proportion of patients with glucocorticoid dose = 5 mg/day at Week 24 and Week 52, respectively;Proportion of patients having discontinued glucocorticoids by Week 52;Proportion of patients with glucocorticoid dose =5 mg/day at Week 52 without experiencing a flare throughout the 52-week period; Proportion of patients achieving Lupus Low Disease Activity State (LLDAS) with glucocorticoid dose =5 mg/day at Week 52 without experiencing a flare throughout the 52-week period.;Proportion of patients meeting the Definition of Remission in SLE (DORIS) criteria at Week 24 and Week 52, respectively;Proportion of patients with no change in SDI score from baseline (?SDI=0) at Week 52; | — |
Countries
China
Contacts
Public ContactZhu Chen
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed