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Efficacy and Safety of IL-1 Inhibitors in Mild to Moderate Systemic Lupus Erythematosus

NCT07381465 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-02

No results posted yet for this study

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 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

Interventions

DRUG

Firsekibart

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.

Sponsors & Collaborators

  • Chinese SLE Treatment And Research Group

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-12-20
Completion
2027-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07381465 on ClinicalTrials.gov