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Anifrolumab for Pediatric Systemic Lupus Erythematosus

This study is testing anifrolumab, a biological medicine, in children aged 5 to 17 who have moderate to severe Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease that can affect many parts of the body. The study aims to understand how anifrolumab works in the body, how safe it is, and if it helps improve symptoms compared to a placebo (an inactive substance). You would receive anifrolumab or a placebo through an IV infusion. The main goals are to measure the levels of anifrolumab in the blood over time. The study is currently unclear on its recruitment status and plans to enroll 100 participants.

Study design
This is an interventional study with a planned enrollment of 100 participants. It includes double-blind (neither you nor your doctor know if you're getting the study drug or placebo) and open-label (everyone knows what they are receiving) periods.
What's involved
Your participation would last approximately 116 weeks, including screening, treatment periods, and a safety follow-up.
Compensation
Not stated in the trial record.
Follow-up
There will be one safety follow-up visit 12 weeks after your last dose of the study medicine.

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NCT05835310

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

Recruiting
PHASE3Ages 5–17InterventionalTreatment
AstraZeneca
~100 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:AnifrolumabPlacebo

At a glance

Recruiting sites
80 of 100 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A- Anifrolumab serum concentration
Measured over Pre-dose Day 29
+4 more outcomes measured

Conditions

Systemic Lupus Erythematosus

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

100 sites across 32 states
China10
Japan10
Spain7
United Kingdom7
Italy6
Brazil5
France5
Mexico5

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant's parent/caregiver/legally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation.
Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for at least 3 months prior to signing the ICF.
At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central Adjudication Committee, defined as:
Participant should meet all of following tuberculosis (TB) criteria:
Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
Female participants of childbearing and male participants must adhere to the contraception methods.

Exclusion

Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.
History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.
In participants aged 11 years and above: history or evidence of suicidal ideation.
History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
Any positive result on screening for human immunodeficiency virus.
Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any active or recent case of Herpes Zoster infection.
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
History of severe COVID-19 infection requiring hospitalization, intensive care unit care, or assisted ventilation or any prior COVID-19 infection with unresolved sequelae. Any mild/asymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms).
Prior use of anifrolumab.
Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) \< 26 weeks prior to ICF signature.
Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.

What this trial measures

  • Part A- Anifrolumab serum concentrationPre-dose Day 29

    The serum concentration will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severely active SLE.

  • Part A - Maximum observed serum (peak) drug concentration (Cmax)Up to Day 29

    The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severely active SLE.

  • Part A - Area under the serum concentration curve (AUC)Up to Day 29

    The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severe active SLE.

  • Part A - Minimum observed serum concentration (Cmin)Up to Day 29

    The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severe active SLE.

  • Part B - Number of participants who are British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responders (yes/no)At Week 52

    BICLA response is defined as: * Reduction of all baseline British Isles Lupus Assessment Group BILAG-2004 A to B/C/D and B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG- 2004 B. * No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), defined as an increase from baseline of \> 0 points. * No worsening from baseline in participant's lupus disease activity, defined by an increase ≥ 0.30 points on a Physician's Global Assessment (PGA) 3-point visual analogue scale (VAS).