An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 5 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 1 visit
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "One safety visit at 12 weeks post last dose."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests anifrolumab given through a vein in children with moderate to severe active lupus (SLE). It looks at how well the drug works, its safety, and how the body handles and responds to it.
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- A parent, caregiver, or legal representative must give written permission. The child must also agree when local rules require it.
- Have had a lupus diagnosis that meets the study's rules for at least 3 months before signing the consent form.
- Have moderate to severe active lupus that meets the study's symptom and disease score rules at screening and on Day 1.
- Have no signs or history suggesting active tuberculosis (TB), an infection. Any recent contact with someone with active TB needs a specialist's review and treatment if needed. Any past inactive TB must have documented completed treatment before screening.
- Girls who can become pregnant must have negative pregnancy tests at screening and when assigned to a study group.
- Girls who can become pregnant and boys must follow the study's birth control rules.
Who can't join
- Have an interferon-related inflammatory disease, or a history of serious blood vessel swelling not caused by lupus.
- For children age 11 or older, have current or past thoughts of suicide.
- Have a disease other than lupus that needed steroid pills or injections for more than 2 weeks total in the 24 weeks before consent.
- Test positive for HIV, have the listed positive hepatitis B or C test results, or have active or recent shingles.
- Have cytomegalovirus or Epstein-Barr virus infection that has not fully cleared within the 12 weeks before consent.
- Have had severe COVID-19 needing hospital care, intensive care, or breathing support; have lasting effects from COVID-19; or have any mild or symptom-free COVID-19 infection, confirmed or suspected.
- Have used anifrolumab before, or received a drug that kills certain immune cells, such as rituximab, less than 26 weeks before consent.
- Have received a blood transfusion or blood products other than albumin within 4 weeks before consent.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (22)
AZ
- Research Site · Phoenix, AZ 85016More trials in Phoenix
CA
- Research Site · Los Angeles, CA 90027More trials in Los Angeles
DC
- Research Site · Washington D.C., DC 20010More trials in Washington D.C.
IL
- Research Site · Chicago, IL 60611More trials in Chicago
- Research Site · Chicago, IL 60637More trials in Chicago
LA
- Research Site · New Orleans, LA 70118More trials in New Orleans
MD
- Research Site · Bethesda, MD 20889More trials in Bethesda
MN
- Research Site · Saint Paul, MN 55125More trials in Saint Paul
NC
- Research Site · Durham, NC 27710More trials in Durham
NY
- Research Site · New Hyde Park, NY 11042More trials in New Hyde Park
- Research Site · New York, NY 10032More trials in New York
- Research Site · The Bronx, NY 10467More trials in The Bronx
- Research Site · Valhalla, NY 10595More trials in Valhalla
OH
- Research Site · Cincinnati, OH 45229More trials in Cincinnati
- Research Site · Cleveland, OH 44109More trials in Cleveland
- Research Site · Columbus, OH 43203More trials in Columbus
OR
- Research Site · Portland, OR 97227More trials in Portland
PA
- Research Site · Philadelphia, PA 19104More trials in Philadelphia
SC
- Research Site · Greenville, SC 29605More trials in Greenville
TX
- Research Site · El Paso, TX 79902More trials in El Paso
- Research Site · Houston, TX 77030More trials in Houston
UT
- Research Site · Salt Lake City, UT 84108More trials in Salt Lake City