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Clinical Trials in the USA / NCT07024563
Recruiting Phase 3

Study of Ravulizumab in Pediatric Participants With Primary IgAN

NCT07024563 · tracked via the Priya Life Science USA tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2025-06-14
Last updated
2026-07-30

Condition(s) studied

IgANIgAVNImmunoglobulin A NephropathyImmunoglobulin A Vasculitis Associated NephritisHenoch-schonlein Purpura NephritisIgA Vasculitis

Investigational drug(s) / intervention(s)

Ravulizumab

Ravulizumab: Participants will receive Ravulizumab via intravenous (IV) infusion.

Study summary

The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or IgAVN.

Eligibility

Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Participant must be 2 to \< 18 years of age at the time of signing the informed consent or assent. * Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106. * UPCR ≥ 1.0 g/g from the mean of 3 first morning voids (FMV) collected within 1 week during the Screening Period * Estimated GFR ≥ 30 mL/min/1.73 m2 during Screening * Meningococcal infection vaccine * Haemophilus influenzae type b and Streptococcus pneumoniae vaccine * Participants who are receiving SGLT2i, DEARA (eg, sparsentan), MRA, ERA, or GLP-1 agonists must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 34. * Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3 years prior to Screening or during the Screening Period Exclusion Criteria: * Diagnosis of rapidly progressive glomerulonephritis * Secondary forms of IgAN not in the context of primary IgAN or IgAV * Concomitant clinically significant renal disease other than IgAN or IgAVN * Clinical remission of IgAN/IgAVN or clinically significant improvement in proteinuria within the last 6 months. * Uncontrolled diabetes mellitus with HbA1c \> 8.5% * History of kidney transplant or planned kidney transplant during the Primary Evaluation Period. * History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant * Splenectomy or functional asplenia * Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening. * Hemolytic uremic syndrome diagnosed any time prior to Screening. * Planned urological surgery expected to influence kidney function within the study time frame. * Congenital immunodeficiency * Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment * Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior to Screening

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Research Site Palo Alto California Not Yet Recruiting
Research Site Aurora Colorado Recruiting
Research Site Beijing China Recruiting
Research Site Shanghai China Recruiting
Research Site Genova Italy Recruiting
Research Site Roma Italy Recruiting
Research Site Torino Italy Recruiting
Research Site Wakayama Japan Recruiting
Research Site Seoul South Korea Recruiting
Research Site Almería Spain Not Yet Recruiting
Research Site Barcelona Spain Recruiting
Research Site Barcelona Spain Recruiting
Research Site Seville Spain Recruiting
Research Site Taipei Taiwan Recruiting
Research Site Taoyuan Taiwan Recruiting

On this site

📄 Ultomiris (ravulizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07024563 on ClinicalTrials.gov ↗ ← All trials in the USA