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

NCT ID: NCT06360068

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2025-05-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sulfasalazine group

Group Type: EXPERIMENTAL

Sulfasalazine Tablets

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qiong Fu

OTHER

Sponsor Role: lead

Responsible Party

Qiong Fu

Clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

qiong Fu

Role: CONTACT

14749@renji.com

86-021-53882280

Other Identifiers

82371767

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SLE-SASP POC

Identifier Type: -

Identifier Source: org_study_id