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

Launched by ASTRAZENECA · Apr 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Anifrolumab, which is given through an intravenous (IV) line, to see how well it works and how safe it is for treating children with a condition called systemic lupus erythematosus (SLE), which is an autoimmune disease that can cause inflammation and damage to various parts of the body. The trial is looking for children aged 18 to 26 and from 6 to 209 years old who have been diagnosed with SLE for at least six months. They must not have certain infections, like tuberculosis or COVID-19, and should not have had severe health issues related to these conditions.

Participants in the trial will receive treatment with Anifrolumab and will be closely monitored for its effects. They will have tests and check-ups to ensure their safety and to see how well the medication is working. If you think your child might be eligible and you want to learn more, this could be an opportunity to help advance research in treating SLE while also receiving medical care.

Gender

ALL

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 6 months prior to signing the ICF.
• * 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 pregnancy test at Screening.
• • Female participants of childbearing and non-childbearing potential and male participants must adhere to the contraception methods.
• • At screening, negative SARS-CoV-2 RT-PCR or rapid antigen test result and no known or suspected COVID-19 infection or exposure between screening and randomization visits.
• 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 severe 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.