IgG4-RD refers to IgG4-related disease, a chronic fibroinflammatory immune-mediated condition that can involve multiple organs, including pancreas, salivary glands, biliary tract, kidneys, and retroperitoneum. It is characterized by tumefactive lesions and tissue infiltration by IgG4-positive plasma cells. Early recognition is important because many patients respond to immunosuppressive therapy.
Sanofi's oral BTK inhibitor rilzabrutinib received orphan drug designation in Japan for IgG4-related disease and warm autoimmune hemolytic anemia, while also securing U.S. FDA breakthrough therapy designation for the rare anemia indication.
Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to Sanofi's rilzabrutinib for IgG4-related disease, marking the third global orphan designation for this indication based on positive phase 2 study data.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06978738 |
UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases |
NOT_YET_RECRUITING | PHASE1 |
| NCT04918147 |
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) |
TERMINATED | PHASE2 |
| NCT02725476 |
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD) |
COMPLETED | PHASE2 |
