Lupus Erythematosus, SystemicPhase 4NCT07381465
Efficacy and Safety of IL-1 Inhibitors in Mild to Moderate Systemic Lupus Erythematosus
A Phase 4 study testing Firsekibart in people with Lupus Erythematosus, Systemic, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial summary
Systemic lupus erythematosus (SLE) is a systemic autoimmune disorder in which pro-inflammatory factors of the IL-1 family play a pivotal role in its pathogenesis. In SLE patients, an innate immune hyperreactivity coupled with excessive inflammasome activation leads to substantial IL-1β production, triggering… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Firsekibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 65 years, male or female; female participants must not be pregnant or breastfeeding and must agree to use effective contraception during the trial period.
- Meets the 2012 SLICC classification criteria for SLE or the 2019 ACR/EULAR classification criteria for SLE;
- Mild to moderate disease activity, 1 point ≤ SLEDAI ≤ 12 points (cSLEDAI ≠ 0);
- The presence of at least one of the following recent clinical manifestations: fever (excluding fever caused by infection, tumor, endocrine or metabolic disorders, central nervous system diseases, medications, or physical factors), serositis (such as pericarditis or pleurisy), arthritis, rash, or alopecia;
- ESR or CRP exceeds the upper limit of normal, i.e. ESR > 20 mm/h or CRP > 10 mg/L;
- Patients had received standard therapy prior to study drug administration: ≤1 immunosuppressive agent for at least 12 weeks (methotrexate ≤15 mg/week, azathioprine ≤100 mg/day, mycophenolate mofetil ≤1.5 g/day, tacrolimus ≤2 mg/day, cyclosporine ≤150 mg/day, sirolimus ≤1.5 mg/day); Hydroxychloroquine (HCQ) may be used; Patients previously treated with biologics (e.g., Belimumab, Telitacicept, Anifrolumab) with inadequate response may also be considered for inclusion, provided they undergo a washout period of three half-lives during screening.
- The patient voluntarily participated in this trial, demonstrated good compliance, and possessed the capacity to understand and sign the informed consent form prior to the study.
Who cannot join
- SLE with major organ dysfunction, including impaired consciousness, cognitive decline, renal insufficiency, cardiac insufficiency (NYHA class 3 or 4), pulmonary hypertension, and pulmonary interstitial disease.
- Active SLE organ involvement, including but not limited to active lupus encephalopathy, active lupus nephritis (proteinuria ≥1g/24h), cardiac involvement, gastrointestinal involvement, diffuse alveolar haemorrhage, thrombocytopenic purpura, hemophagocytic syndrome, and retinopathy.
- SLE coexisting with other autoimmune diseases potentially affecting efficacy assessment, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
- Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal; total bilirubin (TBIL) > 1 times the upper limit of normal.
- Any active malignancy or history of malignancy within the preceding five years.
- Concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease.
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- Acute or chronic infections requiring anti-infective treatment, including but not limited to tuberculosis, HBV or HCV infection, HIV infection, or CMV infection.
- Major surgical procedures within the preceding three months.
- Hypersensitivity or intolerance to Firsekibart; individuals with known hypersensitivity to Chinese hamster ovary (CHO) cell-derived products should also be excluded (Firsekibart is a recombinant monoclonal antibody with potential residual CHO expression risk).
- Pregnancy, planned pregnancy, or lactation.
- Use of biological agents within 3 months prior to enrolment, including but not limited to CD20 monoclonal antibodies (e.g., rituximab), B-lymphocyte stimulatory factor inhibitors (e.g., belimumab, telitacicept), or TNF-α inhibitors (e.g., adalimumab, infliximab).
- Receipt within 3 months prior to enrolment of high-dose glucocorticoids (prednisolone or equivalent ≥60mg qd), plasma exchange, IVIG, or oral/intravenous cyclophosphamide.
- Individuals who have received live attenuated vaccines (e.g., varicella, herpes zoster, intranasal influenza vaccines) within 3 months prior to enrolment, or who plan to receive live vaccines during the study period.
- Any condition deemed by the investigator to potentially prevent the subject from completing the study or pose a significant risk to the subject.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Efficacy and Safety of IL-1 Inhibitors in the Treatment of Mild to Moderate Systemic Lupus Erythematosus With Inadequate Response to Conventional Therapy: A Single-Centre, Single-Arm, Pilot Study
Systemic lupus erythematosus (SLE) is a systemic autoimmune disorder in which pro-inflammatory factors of the IL-1 family play a pivotal role in its pathogenesis. In SLE patients, an innate immune hyperreactivity coupled with excessive inflammasome activation leads to substantial IL-1β production, triggering inflammatory phenotypes such as fever and serositis. For SLE patients unresponsive to conventional therapies, particularly those exhibiting high fever and serositis indicative of innate immune overactivation, effective targeted treatments remain scarce. Firsekibart, as a first anti-IL-1β biologic, holds promise in delivering novel therapeutic benefits for SLE patients with high-inflammatory phenotypes who prove refractory to standard therapies.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Firsekibart
- 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.
FirsekibartDrug
Firsekibart combined with standard therapy: subcutaneous injection of 200mg Firsekibart at weeks 0, 4 and 8. Discontinue Firsekibart at weeks 12-24, with all other standard treatments unchanged. Observe for recurrence; if recurrence occurs, patients will be removed from the group and receive additional medication.
| Study group | Role | What they receive |
|---|---|---|
| Firsekibart group | Experimental | Firsekibart combined with standard therapy: subcutaneous injection of 200mg Firsekibart at weeks 0, 4 and 8. Firsekibart monotherapy discontinued at weeks 12-24, with all other standard treatments unchanged. Observe for recurrence; if recurrence occurs, patients will be removed from the group and receive additional therapy. Receives: Drug: Firsekibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients achieving an BICLA response at the end of 12 weeks
The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline)
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (15)
the percentage of patients achieving an BICLA response at the end of 24 weeks
The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline)
Measured: From enrollment to the end of treatment at 24 weeks
the percentage of patients achieving SRI-4 response at the end of 12 weeks.
The SRI-4（SLE Responder Index-4） response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (<0.3 points worsening from the baseline level).
Measured: From enrollment to the end of treatment at 12 weeks
the percentage of patients achieving SRI-4 response at the end of 24 weeks.
The SRI-4（SLE Responder Index-4） response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (<0.3 points worsening from the baseline level).
Measured: From enrollment to the end of treatment at 24 weeks
Changes from baseline in SLEDAI at 24 weeks
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and 12-16 representing severe disease activity
Measured: From enrollment to the end of treatment at 24 weeks
Changes from baseline in SLEDAI at 12 weeks
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and 12-16 representing severe disease activity
Measured: From enrollment to the end of treatment at 12 weeks
Changes from baseline in PGA at 24 weeks
PGA stands for Physician's Global Assessment (PGA ) . It is used to assess the activity of systemic lupus erythematosus on a scale ranging from 0 to 3, where 0 indicates no disease activity and 3 indicates the most severe disease activity.
Measured: From enrollment to the end of treatment at 24 weeks
Changes from baseline in PGA at 12 weeks
PGA stands for Physician's Global Assessment (PGA ) . It is used to assess the activity of systemic lupus erythematosus on a scale ranging from 0 to 3, where 0 indicates no disease activity and 3 indicates the most severe disease activity.
Measured: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the SJC and TJC at 24 weeks
Swollen Joint Count(SJC) and Tender Joint Count(TJC) indicate the number of swollen and tender joints in 28 joints, respectively. 28 joints refer to both shoulders, both elbows, both wrists, both knees, 10 metacarpophalangeal joints, and 10 proximal interphalangeal joints, which ranging from 0 to 28, the higher value means more serious disease activity.
Measured: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the SJC and TJC at 12 weeks
Swollen Joint Count(SJC) and Tender Joint Count(TJC) indicate the number of swollen and tender joints in 28 joints, respectively. 28 joints refer to both shoulders, both elbows, both wrists, both knees, 10 metacarpophalangeal joints, and 10 proximal interphalangeal joints, which ranging from 0 to 28, the higher value means more serious disease activity.
Measured: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the levels of Erythrocyte Sedimentation Rate (ESR) at 24 weeks
The erythrocyte sedimentation rate (ESR) is used to indicate the level of inflammation. In this study, the normal range is 0-15 mm/h. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Measured: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the levels of Erythrocyte Sedimentation Rate (ESR) at 12 weeks
The erythrocyte sedimentation rate (ESR) is used to indicate the level of inflammation. In this study, the normal range is 0-15 mm/h. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Measured: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the CLASI score at 24 weeks
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was used in this study to evaluate disease activity and lesion severity in cutaneous SLE involvement. Scores of 0-9 indicate mild disease, 10-20 moderate disease, and 21-70 severe disease.
Measured: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the CLASI score at 12 weeks
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was used in this study to evaluate disease activity and lesion severity in cutaneous SLE involvement. Scores of 0-9 indicate mild disease, 10-20 moderate disease, and 21-70 severe disease.
Measured: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the levels of C-Reaction Protein (CRP) at 24 weeks
The c-reaction protein (CRP) is used to indicate the level of inflammation. In this study, the normal range is 0-10 mg/L. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Measured: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the levels of C-Reaction Protein (CRP) at 12 weeks
The c-reaction protein (CRP) is used to indicate the level of inflammation. In this study, the normal range is 0-10 mg/L. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start16 Jun 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381465
- Sponsor's protocol ID
- CSTAR012
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of IL-1 Inhibitors in the Treatment of Mild to Moderate Systemic Lupus Erythematosus With Inadequate Response to Conventional Therapy: A Single-Centre, Single-Arm, Pilot Study
- ClinicalTrials.gov ID
- NCT07381465
- Acronym / sponsor ID
- CSTAR012
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (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.
Systemic lupus erythematosus (SLE) is a systemic autoimmune disorder in which pro-inflammatory factors of the IL-1 family play a pivotal role in its pathogenesis. In SLE patients, an innate immune hyperreactivity coupled with excessive inflammasome activation leads to substantial IL-1β production, triggering inflammatory phenotypes such as fever and serositis. For SLE patients unresponsive to conventional therapies, particularly those exhibiting high fever and serositis indicative of innate immune overactivation, effective targeted treatments remain scarce. Firsekibart, as a first anti-IL-1β biologic, holds promise in delivering novel therapeutic benefits for SLE patients with high-inflammatory phenotypes who prove refractory to standard therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firsekibart group | Experimental | Drug: FirsekibartFirsekibart combined with standard therapy: subcutaneous injection of 200mg Firsekibart at weeks 0, 4 and 8. Firsekibart monotherapy discontinued at weeks 12-24, with all other standard treatments unchanged. Observe for recurrence; if recurrence occurs, patients will be removed from the group and receive additional therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 65 years, male or female; female participants must not be pregnant or breastfeeding and must agree to use effective contraception during the trial period.
- Meets the 2012 SLICC classification criteria for SLE or the 2019 ACR/EULAR classification criteria for SLE;
- Mild to moderate disease activity, 1 point ≤ SLEDAI ≤ 12 points (cSLEDAI ≠ 0);
- The presence of at least one of the following recent clinical manifestations: fever (excluding fever caused by infection, tumor, endocrine or metabolic disorders, central nervous system diseases, medications, or physical factors), serositis (such as pericarditis or pleurisy), arthritis, rash, or alopecia;
- ESR or CRP exceeds the upper limit of normal, i.e. ESR > 20 mm/h or CRP > 10 mg/L;
Key exclusion criteria (14 listed)
- SLE with major organ dysfunction, including impaired consciousness, cognitive decline, renal insufficiency, cardiac insufficiency (NYHA class 3 or 4), pulmonary hypertension, and pulmonary interstitial disease.
- Active SLE organ involvement, including but not limited to active lupus encephalopathy, active lupus nephritis (proteinuria ≥1g/24h), cardiac involvement, gastrointestinal involvement, diffuse alveolar haemorrhage, thrombocytopenic purpura, hemophagocytic syndrome, and retinopathy.
- SLE coexisting with other autoimmune diseases potentially affecting efficacy assessment, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
- Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal; total bilirubin (TBIL) > 1 times the upper limit of normal.
- Any active malignancy or history of malignancy within the preceding five years.
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 |
|---|---|---|
| FirsekibartFirsekibart combined with standard therapy: subcutaneous injection of 200mg Firsekibart at weeks 0, 4 and 8. Discontinue Firsekibart at weeks 12-24, with all other standard treatments unchanged. Observe for recurrence; if recurrence occurs, patients will be removed from the group and receive additional medication. | Drug | Firsekibart group |
Primary outcome
the percentage of patients achieving an BICLA response at the end of 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline)
15 secondary outcomes
the percentage of patients achieving an BICLA response at the end of 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
the percentage of patients achieving SRI-4 response at the end of 12 weeks.
Time frame: From enrollment to the end of treatment at 12 weeks
the percentage of patients achieving SRI-4 response at the end of 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline in SLEDAI at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline in SLEDAI at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline in PGA at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline in PGA at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the SJC and TJC at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the SJC and TJC at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the levels of Erythrocyte Sedimentation Rate (ESR) at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the levels of Erythrocyte Sedimentation Rate (ESR) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the CLASI score at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the CLASI score at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the levels of C-Reaction Protein (CRP) at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the levels of C-Reaction Protein (CRP) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Firsekibart in people with Lupus Erythematosus, Systemic, run by Chinese SLE Treatment And Research Group at 1 site in China.
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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients achieving an BICLA response at the end of 12 weeks (time frame: From enrollment to the end of treatment at 12 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 15 Jul 2026.