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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Sulfasalazine Tablets

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: qiong Fu; Phone Number: 86-021-53882280; Email: 14749@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sulfasalazine group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the change of prednisone dosage	baseline prednisone dosage subtracts the prednisone dosage at week 16.	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qiong Fu

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: interferon; Systemic Lupus Erythematosus; Sulfasalazine
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Sulfasalazine
• Other Study ID Numbers: SLE-SASP POC; 82371767 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No