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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (7 UK sites)
Research Site
Birmingham B4 6NH, United Kingdom
Research Site
Bristol BS2 8BJ, United Kingdom
Research Site
Liverpool L12 2AP, United Kingdom
Research Site
London NW1 2PG, United Kingdom
Research Site
London WC1N 3JH, United Kingdom
Research Site
Manchester M13 9WL, United Kingdom
Research Site
Southampton SO16 6YD, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
