A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus

Launched by QIONG FU · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a medication called sulfasalazine to see if it is safe and effective for people with active systemic lupus erythematosus (SLE), a condition where the immune system attacks its own tissues. The researchers want to find out if sulfasalazine can help reduce the symptoms of lupus after 16 weeks of treatment. They will also check if this medication can help lower the amount of another drug called prednisone that patients need to take, which is often used to manage inflammation.

To participate in the trial, individuals must be between 18 and 65 years old and have a confirmed diagnosis of lupus with active symptoms. They should already be on stable treatment that includes a low dose of prednisone and possibly other medications. Participants will take sulfasalazine twice a day for 16 weeks and will visit the clinic every four weeks for checkups. This trial is not yet recruiting, but it aims to help improve treatment options for those living with lupus.

Gender

ALL

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.