SLE most commonly refers to systemic lupus erythematosus, a systemic autoimmune disease and the most common form of lupus. It can affect multiple organs and occurs disproportionately in women.
The FDA approved AstraZeneca’s Saphnelo Pen for once-weekly self-administration in adults with systemic lupus erythematosus. Approval was based on Phase III TULIP-SC results showing reduced disease activity versus placebo.
Biogen announced that litifilimab received FDA Breakthrough Therapy Designation for cutaneous lupus erythematosus and will present Phase 2 AMETHYST study results at the 2026 AAD Annual Meeting, with Phase 3 data expected in 2027.
AbbVie reported positive Phase 3 data for Skyrizi's subcutaneous Crohn's disease treatment and is advancing lutikizumab and Rinvoq in hidradenitis suppurativa, with multiple readouts expected throughout 2026 as the company pursues combination therapy strategies.
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
A 24-year-old woman with refractory lupus achieved two successful pregnancies following dual-target CAR-T cell therapy, while bispecific T cell engagers showed efficacy in treatment-refractory antisynthetase syndrome and systemic sclerosis patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07364396 |
Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07260877 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus |
RECRUITING | PHASE2 |
| NCT07203404 |
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases. |
RECRUITING | EARLY_PHASE1 |
| NCT07149402 |
Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus |
NOT_YET_RECRUITING | |
| NCT07148115 |
Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus |
RECRUITING | |
| NCT07107659 |
Safety and Efficacy of ONT01 in Lupus |
RECRUITING | EARLY_PHASE1 |
| NCT07069348 |
SLE Severity Linked to Vitamin D Via Treg Cells in Pediatric Patients |
COMPLETED | |
| NCT06872086 |
Assessment of Blood Indices in Systemic Lupus Erythematosus |
NOT_YET_RECRUITING | |
| NCT06839976 |
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus |
RECRUITING | PHASE1/PHASE2 |
| NCT06775912 |
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases |
RECRUITING | EARLY_PHASE1 |
