A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507977-16-00

Acronym

ALXN1210-NEPH-202

Enrollment

Registered

2024-03-11

Start date

2021-05-10

Completion date

2025-07-15

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)

Brief summary

Percentage change in proteinuria

Detailed description

Common to both disease cohorts: - Percentage change in proteinuria - Change from baseline in eGFR, For LN: - Percentage of participants meeting the criteria for Complete Renal Response - Percentage of participants meeting the criteria for Partial Renal Response - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g - Percentage of participants achieving corticosteroid taper to 7.5 mg/day - Percentage of participants with Renal Flare - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare, For IgAN: - Percentage of participants meeting the criteria for Partial Remission

Interventions

DRUGUltomiris 300 mg/30 mL concentrate for solution for infusion

DRUGConcentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage change in proteinuria	—

Secondary

Measure	Time frame
Common to both disease cohorts: - Percentage change in proteinuria - Change from baseline in eGFR, For LN: - Percentage of participants meeting the criteria for Complete Renal Response - Percentage of participants meeting the criteria for Partial Renal Response - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g - Percentage of participants achieving corticosteroid taper to 7.5 mg/day - Percentage of participants with Renal Flare - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare, For IgAN: - Percentage of participants meeting the criteria for Partial Remission	—

Measure

Time frame

—

Countries

France, Germany, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026