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

NCT04564339 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-01-22

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2025-03-26
Completion
2025-08-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04564339 on ClinicalTrials.gov