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

NCT06360068 | Not Yet Recruiting Phase 2

• 2 other identifiers: SLE-SASP POC82371767
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; Sulfasalazine; interferon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the number of patients who can reach SRI-4

  16 weeks

• the change of prednisone dosage

  16 weeks

Other Outcomes (1)

• the change of interferon stimulating genes (ISG) expression

  16 weeks

Study Arms (1)

Sulfasalazine group

EXPERIMENTAL

Drug: Sulfasalazine Tablets

Interventions

Sulfasalazine Tablets DRUG

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.

Sulfasalazine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of SLE according to the 2012 SLICC SLE classification criteria.
• to 65 years old, regardless of gender.
• Active SLE, i.e. SLEDAI-2K score ≥ 4 points at enrollment.
• Receiving standard of care:
• 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);
• No more than three types of combined classic IS or biological agents, not including HCQ.
• 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.

You may not qualify if:

• Severely active SLE: SLEDAI-2K \>12 at screening.
• 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.

Sponsors & Collaborators

• Qiong Fu: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Sulfasalazine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Central Study Contacts

qiong Fu

CONTACT

86-021-53882280; 14749@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 11, 2024
• Study Start: May 6, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share