EU lupus nephritis · Phase II/III
EU lupus nephritis Phase II/III trials: which studies are recruiting?
Updated 13 September 2026
Six of the 16 EU Phase II/III lupus nephritis trials are recruiting in at least one country. The landscape is led by Phase II and B-cell-directed programs, while renal response remains the dominant efficacy measure.
Study breakdown
16 EU lupus nephritis trials span Phase II to Phase III
Phase II accounts for 10 of the 16 studies. Six are recruiting in at least one EU country.
Intervention strategy
B-cell-directed programs account for most of the landscape, but use very different modalities
10 of 16 trials test B-cell-directed approaches, spanning antibodies, a T-cell-engaging bispecific and CD19-directed CAR-T programs.
B-cell-directed
Obinutuzumab (four studies), ianalumab (two), mosunetuzumab (one), and three CD19 CAR-T programs: YTB323, CC-97540/BMS-986353 and obe-cel/AUTO1.
Complement pathway
ALXN2050, ravulizumab and iptacopan/LNP023 test distinct complement-pathway strategies. Iptacopan is the only one currently recruiting.
Immunoproteasome
PALIZADE evaluated zetomipzomib/KZR-616, with complete renal response at Week 37 as the primary efficacy measure.
Other immune/cellular
Anifrolumab targets the type I interferon pathway; MSV-ALLO evaluates allogeneic mesenchymal cells.
Renal response
Renal response remains the dominant efficacy measure
Renal response or proteinuria
Most trials anchor efficacy in complete or partial renal response, often combining proteinuria, kidney function and treatment constraints. Examples include anifrolumab at Week 52, ianalumab at Week 72 and iptacopan at Week 24 without renal flare.
Validated cohort
All 16 EU Phase II/III lupus nephritis trials
“Recruiting” indicates that at least one EU country is currently listed as recruiting.
| EU CT number | Phase | Status | Program / intervention | Planned n | Scope note |
|---|---|---|---|---|---|
| 2022-502227-22-00 | II | Ended | PALIZADE · zetomipzomib Kezar Life Sciences | 165 | Active LN |
| 2023-504825-38-00 | II | Ended | ALXN2050 Alexion | 91 | LN or IgAN cohorts |
| 2023-505825-15-00 | II | Recruiting | POSTERITY · obinutuzumab Roche | 30 | Pediatric LN |
| 2023-507977-16-00 | II | Ended | Ravulizumab Alexion | 58 | LN or IgAN cohorts |
| 2023-509332-26-00 | II | Recruiting | Iptacopan / LNP023 Novartis | 192 | Active Class III/IV ± V LN |
| 2023-510150-17-00 | II | Recruitment ended | YTB323 Novartis | 73 | Difficult-to-treat SLE or kidney disease due to SLE |
| 2024-519278-37-00 | II | Halted | CC-97540 / BMS-986353 Celgene / BMS | 54 | Active SLE; LN included |
| 2024-519930-22-00 | II | Recruiting | Mosunetuzumab Roche | 28 | SLE with or without active LN |
| 2024-519941-32-00 | II | Not yet recruiting | Obe-cel / AUTO1 Autolus | 32 | Severe refractory SLE with active LN |
| 2024-519985-35-00 | II | Not yet recruiting | OBLUMEN · obinutuzumab AP-HP | Not reported | Pure Class V LN |
| 2023-503628-22-00 | III | Recruitment ended | Obinutuzumab Roche | 219 | Class III/IV LN |
| 2023-506359-68-00 | III | Recruitment ended | Anifrolumab AstraZeneca | 267 | Active proliferative LN |
| 2023-508559-37-00 | III | Recruitment ended | Ianalumab / VAY736 Novartis | 315 | Active LN |
| 2024-515280-60-00 | III | Recruiting | SIRIUS-LN extension · ianalumab Novartis | 311 | Open-label extension |
| 2024-516242-19-00 | III | Recruiting | Obinutuzumab + MMF, steroid-sparing AP-HP | Not reported | Class III/IV ± V LN |
| 2024-514750-67-00 | II/III | Recruiting | MSV-ALLO mesenchymal cells Hospital Universitario Río Hortega | Not reported | LN after inadequate/partial response or recurrence |