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Not yet recruitingNCT06360068Updated Apr 11, 2024

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

A Phase 2 interventional study of Sulfasalazine Tablets in Systemic Lupus Erythematosus, sponsored by Qiong Fu. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Qiong Fu · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Systemic Lupus Erythematosus
  • Sulfasalazine
  • interferon
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Qiong Fu is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Sulfasalazine group

    Drug: Sulfasalazine Tablets

Interventions

  • DrugSulfasalazine 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.

06

What researchers measure

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

    Time frame: 16 weeks

Secondary outcomes

  1. 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)

    Time frame: 16 weeks

  2. the change of prednisone dosage

    baseline prednisone dosage subtracts the prednisone dosage at week 16.

    Time frame: 16 weeks

Other outcomes

  1. 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.

    Time frame: 16 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06360068
Lead sponsor
Qiong Fu
Responsible party
Qiong Fu (Clinical professor, RenJi Hospital) — Sponsor-investigator
First posted
Apr 11, 2024
Start date
May 6, 2024 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Apr 11, 2024

Study contacts

qiong Fu
Contact
14749@renji.com
86-021-53882280

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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