Systemic lupus erythematosus (SLE) is a prototypic autoimmune disease with diverse clinical manifestations including nephritis, arthritis, serositis, cytopenias, and central nervous system involvement. Despite decades of off-label use of hydroxychloroquine and immunosuppressants, only three drugs have been specifically approved for SLE in the past 60 years — belimumab, anifrolumab, and voclosporin (for lupus nephritis) — reflecting the extraordinary challenge of conducting trials in a heterogeneous, relapsing-remitting condition.
Active trials investigate obinutuzumab (anti-CD20) for lupus nephritis, dapirolizumab pegol (anti-CD40L), deucravacitinib (TYK2 inhibitor), iberdomide (CELMoD agent), telitacicept (TACI-Fc fusion targeting BLyS and APRIL), and CAR-T cell therapy for severe refractory SLE. Patient selection using type I interferon gene expression signatures, anti-dsDNA titers, and complement levels guides both eligibility and endpoint assessment.
SLE trials use SLEDAI or BILAG disease activity scores at baseline; lupus nephritis trials typically require kidney biopsy confirmation of Class III/IV or V nephritis.
Frequently Asked Questions — sle systemic lupus Clinical Trials
How many clinical trials are currently recruiting for sle systemic lupus?
ClinicalMetric currently tracks 1 actively recruiting clinical trials for sle systemic lupus, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 1. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for sle systemic lupus?
sle systemic lupus research spans Phase 1 (1 trial). Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a sle systemic lupus clinical trial?
Eligibility criteria for sle systemic lupus trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Top Sponsors
Nanjing Bioheng Biotech Co., Ltd. 1 trial
Recruiting Clinical Trials
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional.
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Last Reviewed: April 2026 ·
Data Methodology