Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT06360068
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of SLE according to the 2012 SLICC SLE classification criteria.
* 18 to 65 years old, regardless of gender.
* Active SLE, i.e. SLEDAI-2K score ≥ 4 points at enrollment.
* Receiving standard of care:
1. Prednisone dosage≤20mg/day, with or without hydroxychloroquine (HCQ,≤400mg/day), classic immunosuppressive agents (IS),ie, mycophenolate mofetil(≤2.0g/day), azathioprine (≤2mg/kg/day), cyclosporine(≤5.0mg/kg/day), tacrolimus(≤3.0mg/day), methotrexate(≤20mg/week), leflunomide(≤40mg/day), or biological agents such as belimumab(≤ 10mg/kg/month) and telitacicept (≤160mg/week);
2. No more than three types of combined classic IS or biological agents, not including HCQ.
3. Prednisone dosage should NOT be increased within one month of the screening period, and the immunosuppressants regimen should be stable for at least one month.
* Agree to sign the informed consent form.
* Agree to receive contraception through intrauterine devices or oral contraceptives (progesterone or compound progesterone) or condoms.
Exclusion Criteria:
* Severely active SLE: SLEDAI-2K \>12 at screening.
* 24-hour urine protein≥ 3g/24 hours.
* eGFR \< 60mL/min/1.73m2 (EPI formula).
* Baseline prednisone dosage\>40mg/d at screening.
* Other autoimmune diseases, such as rheumatoid arthritis, Sjogren's syndrome, myositis, scleroderma, autoimmune liver disease, etc.
* Leukopenia or thrombocytopenia (WBC≤3×109/L or PLT≤50×109/L) not caused by SLE.
* Liver dysfunction (ALT or AST more than twice the normal upper limit).
* Allergic to sulfonamide drugs.
* Pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06360068
Study Brief:
Protocol Section:
NCT06360068