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Taking people in NetherlandsPhase 2

Anifrolumab given under the skin in children and teens with lupus

Tests anifrolumab injections in children and teens with moderate to severe lupus.

Key facts

Who runs it
AstraZeneca
Where
Amsterdam, Rotterdam, and Utrecht, NetherlandsSee the 3 sitesAlso in 9 other countries, 29 sites
Registry title
A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
Status
Recruiting
Phase
Phase 2
People taking part
24 people, planned
Started
31 Aug 2026
Expected to end
5 Sept 2031
Type of study
Interventional, 2 groups
Treatments tested
  • Anifrolumab + APFS
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with moderate to severe active lupus (SLE) who already take standard lupus medicine.

Age
5 to 17 years old.
Sex
All sexes can join.
Disease stage
Moderate to severe active SLE, with a SLEDAI-2K score of 6 points or more.
Earlier treatment
Must have taken at least one standard lupus treatment for 4 weeks or more: oral glucocorticoids, an antimalarial, or one permitted immunosuppressant. Must not have had anifrolumab or B-cell depleting therapy before.

Main reasons for not taking part

  • Active, severe lupus kidney disease with significant protein in the urine
  • Active severe or unstable lupus affecting the brain or nerves
  • Recent suicidal thoughts or behaviour, in those 11 years or older
  • Serious infections, HIV, or active hepatitis B or C
  • History of cancer

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • Diagnosis of SLE
  • Must be receiving at least one of the following SoC regimens for ≥ 4 weeks: oral glucocorticoids (≤1.0 mg/kg/day or ≤ 40 mg/day prednisone equivalent), antimalarials (hydroxychloroquine, chloroquine, or quinacrine), or a single permitted immunosuppressant (azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, mizoribine, or tacrolimus) within specified dose limits
  • Participant must have moderate to severe active SLE disease defined as Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) ≥ 6 total points
  • Body weight ≥ 15 kg
  • Participants must agree to follow study specific contraception requirements as per local regulations

Who cannot take part

  • Any active or recent herpes zoster (HZ) infection that has not completely resolved within 12 weeks prior to study entry or that emerges between screening and Day 1
  • Any history of severe or recurrent HZ, including non-cutaneous HZ, herpes encephalitis, ophthalmic herpes, or 2 or more prior HZ episodes
  • Prior receipt of anifrolumab
  • Prior treatment with directly acting cytotoxic B-cell depleting therapeutics
  • History of, or current diagnosis of, clinically significant non-SLE related vasculitides
  • Active, severe SLE-driven renal disease with significant proteinuria
  • Active severe or unstable neuropsychiatric SLE including but not limited to aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex
  • History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS)
  • History of recurrent or opportunistic infection requiring hospitalization and intravenous (IV) antibiotics
  • Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection
  • Active hepatitis B and C infection
  • Any cytomegalovirus (CMV) or Epstein Barr virus (EBV) infection that has not completely resolved
  • History of cancer
  • A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy, human proteins, or monoclonal antibodies (mAbs)
  • In participants ≥ 11 years of age, a history or evidence of suicidal ideation (severity of 4 [active: method and intent, but no plan] or 5 [active: method, intent, and plan]) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia suicide severity rating scale (C-SSRS)
  • Known diagnosis of an IFN mediated autoinflammatory interferonopathy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 5 and 17 years old?

Where in Netherlands

Also in 9 other countries, 29 sites

  • Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people

About the trial

What the trial wants to find out

The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.

The 2 groups in the trial

  • Cohort 1 (body weight > 40 kg)Treatment being tested

    Participants with body weight \> 40 kg will receive anifrolumab as an injection in APFS.

    Treatment: Anifrolumab + APFS

  • Cohort 2 (body weight ≥ 15 to ≤ 40 kg)Treatment being tested

    Participants with body weight ≥ 15 to ≤ 40 kg will receive anifrolumab as an injection in APFS.

    Treatment: Anifrolumab + APFS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Multicenter, Open-Label, Phase II Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
Plain-language title
Anifrolumab given under the skin in children and teens with lupusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07630714, who can take part
Record updated
28 October 2026