drugset / Trial / NCT04564339
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
RandomizedParallel-groupTriple-blindTreatment
Summary
The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).
Timeline
- Start
- 2021-01-19
- Primary completion
- 2025-03-26
- Completion
- 2025-08-18
Outcome
Mixed primary results
Stopped (Business): “Sponsor Decision.”
registry analysis (superiority test); IgAN Cohort: Ravulizumab vs IgAN Cohort: Placebo; p = 0.0053; Percentage Difference -30.1 (90% CI -43.5 to -13.7); ANCOVA NCT04564339 ↗
registry analysis (superiority test); LN Cohort: Ravulizumab vs LN Cohort: Placebo; p = 0.8036; Percentage Difference -8.4 (90% CI -48.6 to 63.2); ANCOVA NCT04564339 ↗
Publications
- Lafayette R, Tumlin J, Fenoglio R, Kaufeld J, Perez Valdivia MA, Wu MS, Susan Huang SH, Alamartine E, Kim SG, Yee M, Kateifides A, Rice K, Garlo K, Barratt J; SANCTUARY Study Investigators. Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Apr 1;36(4):645-656. doi: 10.1681/ASN.0000000534. Epub 2024 Oct 25.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ravulizumab | Monoclonal antibody | — | Intravenous |