NCT04564339

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

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: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

Conditions

• Lupus Nephritis
• Immunoglobulin A Nephropathy

Interventions

Type	Name	Description
DRUG	Ravulizumab	Dosages (loading and maintenance) will be based on the participant's body weight.
DRUG	Placebo	Dosages (loading and maintenance) will be based on the participant's body weight.
OTHER	Background Therapy	Participants will receive background therapy consistent with the standard of care.

Timeline

• Start date: 2021-01-19
• Primary completion: 2025-03-26
• Completion: 2025-08-18
• First posted: 2020-09-25
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

64 sites across 12 countries: United States, Australia, Canada, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study