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An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
100 patients around the world
Available in Spain, Colombia, Brazil, Argentina, Mexico, United States
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, single-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.
AstraZeneca
100Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.Participant should meet all of following tuberculosis (TB) criteria:A. No signs or symptoms of active TBB. No medical history or past physical examinations suggestive of active TBC. 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 SoCD. No history of latent TB without documented completion of treatment prior to initial screening visitFemale 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 antigen test result and no known or suspected COVID-19 infection or exposure between screening and randomization visits.
- Known diagnosis of a monogenic form of SLE.History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.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.
StudySLE
SponsorAstraZeneca
Conditions
Systemic lupus erythematosus
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05835310
