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Intravenous anifrolumab for children with moderate to severe systemic lupus erythematosus

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy

Phase 3 Interventional AstraZeneca · NCT05835310

This study will try intravenous anifrolumab in children with moderate to severe SLE to see if it is safe and helps control their disease while they remain on standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment100 (estimated)
Ages5 Years to 17 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsanifrolumab, rituximab
Locations98 sites (Phoenix, Arizona and 97 other locations)
Trial IDNCT05835310 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 3 trial compares intravenous anifrolumab plus standard of care to placebo plus standard of care in pediatric participants with moderate to severe active SLE. Part A is a four-week randomized pharmacokinetic/pharmacodynamic period, Part B is a 48–52 week randomized safety and efficacy period depending on prior participation, Part C is a 52-week open-label extension, and Part D is a 12-week safety follow-up, with total participation of approximately 116 weeks. The study collects PK/PD, clinical response, and safety data and includes tuberculosis screening and infection monitoring per protocol. Participants continue their background standard therapies and are randomized to receive anifrolumab infusions or matching placebo.

Who should consider this trial

Good fit: Children who meet the 2019 EULAR/ACR criteria for SLE for at least three months, have moderate to severe active disease, are on standard of care therapy, and can complete TB screening and consent requirements are ideal candidates.

Not a fit: Children with only mild SLE, active untreated tuberculosis, recent high-risk TB exposure without appropriate treatment, or who cannot comply with the long follow-up schedule may not receive benefit from participation.

Why it matters

Potential benefit: If successful, anifrolumab could provide a targeted treatment that better controls disease activity and may reduce reliance on high-dose steroids for children with moderate to severe SLE.

How similar studies have performed: Adult Phase 3 trials of anifrolumab have shown clinical benefit and led to regulatory approval, but pediatric evidence is limited and this trial extends those adult findings to children.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.
* Participant should meet all of following tuberculosis (TB) criteria:

A. No signs or symptoms of active TB B. No medical history or past physical examinations suggestive of active TB C. No recent contact with a person with active TB or if there has been such contact, referral to a TB specialist for evaluation and initiation of treatment for latent TB, if warranted, prior to the first administration of study intervention in accordance with local SoC D. No history of latent TB without documented completion of treatment prior to initial screening visit

* 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 Criteria:

* 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.

Where this trial is running

Phoenix, Arizona and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusSLEMonoclonal AntibodyAnifrolumabParallel-group treatmentPediatric participantsStandard of care therapyIntravenous
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.