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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT05835310

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Anifrolumab (biological), Placebo (drug)
How long the study runs
Study runs about 70 months (dates as stated)
About the drug or intervention
Anifrolumab — biological: Participants will receive anifrolumab via IV infusion. · Placebo — drug: Participants will receive matching placebo via IV infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
5 Years to 17 Years
Who
All
Number of participants
100
Started
2024-03-14
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic lupus erythematosus
  • • Phase3 - 100 participants
  • • A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)

Who can take part?

  • • Ages 5 Years to 17 Years
  • • Diagnosed with systemic lupus erythematosus

Where?

  • • Birmingham - Research Site
  • • Bristol - Research Site
  • • Liverpool - Research Site
  • • London - Research Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)

More detail

This study aims to characterize the pharmacokinetics, pharmacodynamics, efficacy, and safety of anifrolumab solution for infusion compared with placebo solution for infusion in pediatric participants with severe active systemic lupus erythematosus who are on background standard of care therapy. The study duration for a participant will be approximately 116 weeks, which includes: * Screening period of up to 30 days. * Part A consists of a four-week, double-blind, placebo-controlled, randomised, pharmacokinetic period. * Part B is a double-blind, placebo-controlled, randomised, safety/efficacy period lasting 48 weeks (for rollover participants from Part A) or 52 weeks (for de novo participants). * Part C is a 52-week open-label extension period. * Part D is a safety follow-up period. One safety visit at 12 weeks post last dose.

Systemic Lupus Erythematosus

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 5 Years - 17 Years
  • Who can join: All genders

Biomarkers mentioned

have a negativeand negativeAny positive

Treatment history

Treatments you must have had:

  • ✓ a negative serum pregnancy test at screening and negative urine pregnancy test at randomization

What the study is looking for

  • ✓Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology...
  • ✓At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central...
  • ✓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...
  • ✓Female participants of childbearing and male participants must adhere to the contraception methods.

Who cannot take part

  • ✗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...
  • ✗Any positive result on screening for human immunodeficiency virus.
See the full 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. * At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central Adjudication Committee, defined as: (a) SLEDAI-2K activity of: (i) ≥ 6 points with at least 4 points (≥ 4 points) coming from the following clinical components ('Clinical' SLEDAI-2K score): arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis and excluding points attributed to a fever, SLE headache, and organic brain syndrome (ii) Clinical SLEDAI score of ≥ 4 points verified at Day 1 (b) BILAG-2004 activity of: (i) ≥ 1 BILAG A score; or (ii) ≥ 2 BILAG B scores (c) PGA score ≥ 1.0 on a 0 to 3 VAS * 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 Is This Study? (7 UK sites)

Research Site

Birmingham B4 6NH, United Kingdom

Recruiting

Research Site

Bristol BS2 8BJ, United Kingdom

Recruiting

Research Site

Liverpool L12 2AP, United Kingdom

Recruiting

Research Site

London NW1 2PG, United Kingdom

Recruiting

Research Site

London WC1N 3JH, United Kingdom

Recruiting

Research Site

Manchester M13 9WL, United Kingdom

Recruiting

Research Site

Southampton SO16 6YD, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09