drugset / Trial / NCT04221477
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
Timeline
- Start
- 2020-08-10
- Primary completion
- 2024-08-15
- Completion
- 2031-03-02
Outcome
Met primary endpoint
registry analysis (superiority test); Obinutuzumab vs Placebo; p = 0.0232; Adjusted Difference 13.40 (95% CI 1.95 to 24.84) NCT04221477 ↗
release “The REGENCY study met its primary endpoint; nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR)” roche.com ↗
Publications
- Furie RA, Rovin BH, Garg JP, Santiago MB, Aroca-Martinez G, Zuta Santillan AE, Alvarez D, Navarro Sandoval C, Lila AM, Tumlin JA, Saxena A, Irazoque Palazuelos F, Raghu H, Yoo B, Hassan I, Martins E, Sehgal H, Kirchner P, Ross Terres J, Omachi TA, Schindler T, Pendergraft WF 3rd, Malvar A; REGENCY Trial Investigators. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. 2025 Apr 17;392(15):1471-1483. doi: 10.1056/NEJMoa2410965. Epub 2025 Feb 7.
- Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
- Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Acetaminophen | Small molecule | 650 mg | — |
| Background | Acetaminophen | Small molecule | 1000 mg | — |
| Background | Diphenhydramine | Small molecule | 50 mg | — |
| Background | Methylprednisolone | Other / unclassified | 80 mg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 2 g | — |
| Background | Mycophenolate Mofetil | Small molecule | 2.5 g | — |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |