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

Qiong Fu

Status and phase

Not yet enrolling

Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Sulfasalazine Tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT06360068

SLE-SASP POC

82371767 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.