Clinical trial NCT06360068: A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus
Official title: A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Sulfasalazine
interferon
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the change of disease activity (SLEDAI score)
timeFrame: 16 weeks
Secondary outcomes:
measure: the number of patients who can reach SRI-4
timeFrame: 16 weeks
measure: the change of prednisone dosage
timeFrame: 16 weeks
Other outcomes:
measure: the change of interferon stimulating genes (ISG) expression
timeFrame: 16 weeks
Locations:
Study officials:
References: