systemic lupus erythematosus
Conditions
Interventions
Experimental group:Oral Sirolimus Capsules
Control group:Conventional lupus treatment
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. 18-55 years old; 2. Meet the 2012 SLICC classification criteria for systemic lupus erythematosus, patients need to meet at least 4 of the classification criteria, of which at least 1 clinical criterion and 1 immunological criterion are met, or in the case of positive antinuclear antibody or anti-dsDNA antibody, pathologically confirmed lupus nephritis, or meet the 2019 EULAR/ACR SLE classification criteria; Diagnosis of systemic lupus erythematosus for at least 3 months; 3 Subjects must meet the definition of clinical activity at the screening and baseline visits: Systemic Lupus Erythematosus Disease Activity Score (SLEDAI-2000) >=4 points; 4 Subjects have received a stable dose of standard therapy prior to the first dose of study drug, including: glucocorticoids (prednisone 0-30mg/day, or equivalent other preparations) for at least 4 weeks; antimalarials, immunosuppressants (mycophenolate mofetil <=1.5 g/day, methotrexate <=15 mg/week) for at least 8 weeks; ACE inhibitors or angiotensin receptor antagonists, nonsteroidal anti-inflammatory drugs, or other analgesics at stable doses for at least 2 weeks.
Exclusion criteria
Exclusion criteria: 1. Combined with other connective tissue diseases or inflammatory diseases; 2. Any condition that may require multiple courses of systemic glucocorticoid therapy (e.g., uncontrolled asthma, COPD); 3. Neuropsychiatric lupus; 4. Proteinuria >=3.5g/24 hours; eGFR100mg/day within 3 months; or use of calcineurin inhibitors within 3 months; or the application of traditional Chinese medicine or proprietary Chinese medicine (e.g. Tripterygium wilfordii) within 1 month; 8. Major surgical treatment within the past month; 9. Patients with malignant tumors or history of malignant tumors within 5 years prior to screening, or history of lymphoproliferative disorders: Patients with squamous cell carcinoma and basal cell carcinoma of the skin who have been treated and have no evidence of recurrence are allowed to enroll; Patients with carcinoma in situ of the cervix who have documented cure of formal surgery are allowed to enroll; 10. Previous stem cell transplantation (including hematopoietic stem cell transplantation and mesenchymal stem cell transplantation); 11. Have undergone splenectomy; 12. Current infection or infection that is difficult to control requiring antibiotic or antiviral therapy; 13. White blood cell (WBC) count 2 times the upper limit of normal; 15. Has any condition that, in the opinion of the investigator, may cause the subject to be unable to complete this study or pose a significant risk to the subject. Note: The exclusion criteria for drugs other than those allowed by the inclusion criteria are as follows: (1) Other systemic immunomodulators (e.g., leflunomide, tacrolimus, cyclosporine, azathioprine, imidzoribine, etc.) other than drugs are allowed by the inclusion criteria; (2) Received treatment with a topical/cream formulation of cyclosporine A (except for ophthalmic preparations), potent topical glucocorticoids, or other topical immunomodulators (e.g., tacrolimus) within 4 weeks prior to the first dose of study drug; (3) Oral cyclophosphamide within 90 days prior to screening or intravenous cyclophosphamide infusion within 180 days prior to screening; (4) B-cell targeted therapy (e.g., belimumab, rituximab, tetanercept), as follows: Received 1 B-cell targeted therapy within 3 months prior to the first dose of study drug Received > 1 B-cell targeted therapy within 6 months prior to the first dose of study drug, received B-cell clearance therapy (e.g., rituximab) within 12 months prior to the first dose of study drug, or has evidence of persistent B-cell clearance; (5) Received treatment with biologics, including but not limited to anakinra, abatacept, afacept, afacidem, tocilizumab, brodalumab, secukinumab, ixekizumab, therapeutics and investigational drugs targeting TNFa, IL-1, IL-2, IL-6, IL-17 or interferon pathway within 5 half-lives or 3 months (whichever is longer) prior <to the first dose of the study drug; (6) Received epidural, IV, IM, IA, IB, IL administration of glucocorticoids within 6 weeks prior to the first dose of study drug and are currently receiving venom immunotherapy (honeybees
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Near-infrared brain functional imaging related indexes (integral value during the task period);Brain MRI indicators (hippocampal volume, etc.);SRI-4 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLEDAI-2K?PGA?BILAG?SLE-DAS?Complement levels?Anti-dsDNA antibodies?Lymphocyte subsets;anxiety depression cognition?SF-36?SSS-8?FSS; | — |
Countries
China
Contacts
Public ContactXu Jian
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed