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

Study Purpose

A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	5 Years - 17 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05835310
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AstraZeneca
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, Canada, China, Colombia, France, Germany, Italy, Japan, Mexico, Poland, Portugal, South Africa, Spain, Turkey (Türkiye), United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus

Additional Details

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.

Arms & Interventions

Arms

Experimental: Anifrolumab

Randomized participants will receive a single dose of Anifrolumab via IV infusion every 4 weeks

Placebo Comparator: Placebo

Randomized participants will receive matching placebo via IV infusion

Interventions

Biological: - Anifrolumab

Participants will receive a single dose of Anifrolumab via IV infusion.

Drug: - Placebo

Participants will receive matching placebo via IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

Research Site

Phoenix 5308655, Arizona 5551752, 85016

Site Contact

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