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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360068
• Other study ID #: SLE-SASP POC
• Secondary ID: 82371767
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 6, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: qiong Fu
• Phone: 86-021-53882280
• Email: 14749[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Sulfasalazine Tablets
All subjects who meet the inclusion/exclusion criteria will be given sulfasalazine 750mg/dose, twice a day. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient tolerates well.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qiong Fu

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the change of interferon stimulating genes (ISG) expression	the ISG level at baseline subtracts the ISG level at week 4, week 8, week 12 and week 16.	16 weeks
Primary	the change of disease activity (SLEDAI score)	reaching the SLEDAI score based on clinical symptoms and laboratory tests according to the SLEDAI score system	16 weeks
Secondary	the number of patients who can reach SRI-4	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)	16 weeks
Secondary	the change of prednisone dosage	baseline prednisone dosage subtracts the prednisone dosage at week 16.	16 weeks