RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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 (SLE) While on Background Standard of Care Therapy

Quick Facts

Study Start:2024-03-14
Study Completion:2030-03-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05835310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Participant should meet all of following tuberculosis (TB) criteria:
  4. * Female participants of childbearing potential must have a negative pregnancy test at Screening.
  5. * Female participants of childbearing and non-childbearing potential and male participants must adhere to the contraception methods.
  6. * 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.
  1. * Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.
  2. * History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.
  3. * In participants aged 11 years and above: history or evidence of suicidal ideation.
  4. * 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.
  5. * Any positive result on Screening for human immunodeficiency virus.
  6. * 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.
  7. * Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
  8. * 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).
  9. * Prior use of Anifrolumab.
  10. * Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) \< 26 weeks prior to ICF signature.
  11. * Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85016
United States
Research Site
Los Angeles, California, 90027
United States
Research Site
Washington, District of Columbia, 20010
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Bethesda, Maryland, 20889
United States
Research Site
Saint Paul, Minnesota, 55125
United States
Research Site
Bronx, New York, 10467
United States
Research Site
New Hyde Park, New York, 11042
United States
Research Site
New York, New York, 10032
United States
Research Site
Valhalla, New York, 10595
United States
Research Site
Durham, North Carolina, 27710
United States
Research Site
Cincinnati, Ohio, 45229
United States
Research Site
Cleveland, Ohio, 44109
United States
Research Site
Columbus, Ohio, 43203
United States
Research Site
Portland, Oregon, 97227
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Greenville, South Carolina, 29605
United States
Research Site
El Paso, Texas, 79902
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-14
Study Completion Date2030-03-12

Study Record Updates

Study Start Date2024-03-14
Study Completion Date2030-03-12

Terms related to this study

Keywords Provided by Researchers

  • Systemic Lupus Erythematosus
  • SLE
  • Monoclonal Antibody
  • Anifrolumab
  • Parallel-group treatment
  • Pediatric participants
  • Standard of care therapy
  • Intravenous

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus