Study of Ravulizumab in Pediatric Participants With Primary IgAN

Last updated: March 16, 2026
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Circulation Disorders

Dermatomyositis (Connective Tissue Disease)

Collagen Vascular Diseases

Treatment

Ravulizumab

Clinical Study ID

NCT07024563
D928FC00002
2024-520167-13-00
  • Ages 2-18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 2 to < 18 years of age at the time of signing the informedconsent or assent.

  • Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 monthsprior 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 weekduring 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-1agonists must be on a stable and maximum allowed or tolerated dose for ≥ 3 monthsprior to Screening with no planned change in dose through Week 34.

  • Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3years prior to Screening or during the Screening Period

Exclusion

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 inproteinuria within the last 6 months.

  • Uncontrolled diabetes mellitus with HbA1c > 8.5%

  • History of kidney transplant or planned kidney transplant during the PrimaryEvaluation Period.

  • History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bonemarrow transplant

  • Splenectomy or functional asplenia

  • Participants with nephrotic syndrome receiving albumin infusions or with acutekidney 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 studytime frame.

  • Congenital immunodeficiency

  • Active systemic bacterial, viral, or fungal infection within 14 days prior toenrollment

  • Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior toScreening

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Ravulizumab
Phase: 3
Study Start date:
June 14, 2025
Estimated Completion Date:
November 27, 2029

Connect with a study center

  • Research Site

    Beijing, 100045
    China

    Active - Recruiting

  • Research Site

    Beijing 1816670, 100045
    China

    Site Not Available

  • Research Site

    Shanghai, 201102
    China

    Active - Recruiting

  • Research Site

    Shanghai 1796236, 201102
    China

    Site Not Available

  • Research Site

    Genova, 16147
    Italy

    Active - Recruiting

  • Research Site

    Genova 8969657, 16147
    Italy

    Site Not Available

  • Research Site

    Roma, 00165
    Italy

    Active - Recruiting

  • Research Site

    Roma 8957247, 00165
    Italy

    Site Not Available

  • Research Site

    Torino, 10126
    Italy

    Active - Recruiting

  • Research Site

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Research Site

    Wakayama, 641-8510
    Japan

    Active - Recruiting

  • Research Site

    Wakayama 1926004, 641-8510
    Japan

    Site Not Available

  • Research Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Research Site

    Barcelona, 8950
    Spain

    Active - Recruiting

  • Research Site

    Barcelona 3128760, 8950
    Spain

    Site Not Available

  • Research Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Research Site

    Seville, 41013
    Spain

    Active - Recruiting

  • Research Site

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Research Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • Research Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Research Site

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.