Systemic Lupus ErythematosusPhase 2NCT06360068
A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus
A Phase 2 study testing Sulfasalazine Tablets in people with Systemic Lupus Erythematosus, run by Qiong Fu.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Sulfasalazine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2024to 1 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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.
Who cannot join
- 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.
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- Liver dysfunction (ALT or AST more than twice the normal upper limit).
- Allergic to sulfonamide drugs.
- Pregnant or breast-feeding.
Trial locations and contacts
No sites are listed yet.
About this study
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?
Read more
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
- Being tested
- Sulfasalazine Tablets
- Keywords
- Systemic Lupus Erythematosus, Sulfasalazine, interferon
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfasalazine TabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sulfasalazine group | Experimental | Not described Receives: Drug: Sulfasalazine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of disease activity (SLEDAI score)
reaching the SLEDAI score based on clinical symptoms and laboratory tests according to the SLEDAI score system
Measured: 16 weeks
Secondary outcomes (2)
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)
Measured: 16 weeks
the change of prednisone dosage
baseline prednisone dosage subtracts the prednisone dosage at week 16.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start6 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiong Fu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiong Fu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360068
- Sponsor's protocol ID
- SLE-SASP POC
- Other IDs
- 82371767
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06360068
- Acronym / sponsor ID
- SLE-SASP POC
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Sulfasalazine, interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qiong FuUniversity, hospital or other
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulfasalazine group | Experimental | Drug: Sulfasalazine Tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Agree to sign the informed consent form.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfasalazine TabletsAll 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. | Drug | Sulfasalazine group |
Primary outcome
the change of disease activity (SLEDAI score)
Time frame: 16 weeks
reaching the SLEDAI score based on clinical symptoms and laboratory tests according to the SLEDAI score system
2 secondary outcomes
the number of patients who can reach SRI-4
Time frame: 16 weeks
the change of prednisone dosage
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfasalazine Tablets in people with Systemic Lupus Erythematosus, run by Qiong Fu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qiong Fu (86-021-53882280, 14749@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of disease activity (SLEDAI score) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.