Subcutaneous anifrolumab in children with systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter phase 2 study in pediatric participants aged 5 to under 18 with systemic lupus erythematosus evaluates the pharmacokinetics and pharmacodynamics of subcutaneously administered anifrolumab, in addition to background standard-of-care therapy. It includes an initial screening, a 12-week treatment period (Period A), a possible dosing-adjustment period (Period B), an optional up-to-40-week treatment extension, and a 12-week safety follow-up (Period C). The intervention uses an accessorized pre-filled syringe for subcutaneous dosing across two cohorts. Primary goals focus on how the drug is processed by the body, how it affects biological markers, and overall safety in this pediatric population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Known diagnosis of an IFN mediated autoinflammatory interferonopathy.
* 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.
* 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).
* 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 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.
* Any cytomegalovirus (CMV) or Epstein Barr virus (EBV) infection that has not completely resolved.
* History of cancer.
* Prior receipt of anifrolumab.
* Prior treatment with directly acting cytotoxic B-cell depleting therapeutics.
* 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).

Where it's running

• Research Site
  Belgrade, Serbia Recruiting
• Research Site
  Niš, Serbia Recruiting
• Research Site
  Nedlands, Australia Not yet recruiting
• Research Site
  Parkville, Australia Not yet recruiting
• Research Site
  Southport, Australia Not yet recruiting
• Research Site
  Westmead, Australia Not yet recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Anifrolumab Pregnancy Study in women with lupus

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• Monitoring pregnancy and infant outcomes after anifrolumab exposure

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.