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

Phase 2

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Sulfasalazine Tablets

• Registration Number: NCT06360068
• Lead Sponsor: Qiong Fu

Brief Summary

The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:

Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16?

Participants will:

Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate.

Visit the clinic once every 4 weeks for checkups and tests.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Study Start: 2024-05-06
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sulfasalazine group	Sulfasalazine Tablets	-

Primary Outcome Measures

Name	Time	Method
the change of disease activity (SLEDAI score)	16 weeks	reaching the SLEDAI score based on clinical symptoms and laboratory tests according to the SLEDAI score system

Secondary Outcome Measures

Name	Time	Method
the change of prednisone dosage	16 weeks	baseline prednisone dosage subtracts the prednisone dosage at week 16.
the number of patients who can reach SRI-4	16 weeks	SRI-4 is defined as: 1.the SELENA-SLEDAI score decreased by ≥ 4 points compared to baseline, and there were no new BILAG grade A or ≤ 2 new BILAG grade B compared to baseline, and the overall physician assessment (PGA) did not deteriorate (an increase of\<0.30 points from baseline)