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Clinical Trials in the UK / NCT05835310
Recruiting Phase 3

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

NCT05835310 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-03-14
Last updated
2026-09-10

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

AnifrolumabPlacebo

Anifrolumab: Participants will receive anifrolumab via IV infusion.

Placebo: Participants will receive matching placebo via IV infusion

Study summary

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)

Eligibility

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (103)

FacilityCityRegionStatus
Research Site Phoenix Arizona Recruiting
Research Site Los Angeles California Recruiting
Research Site Washington D.C. District of Columbia Recruiting
Research Site Chicago Illinois Recruiting
Research Site Chicago Illinois Recruiting
Research Site New Orleans Louisiana Recruiting
Research Site Bethesda Maryland Withdrawn
Research Site Saint Paul Minnesota Recruiting
Research Site New Hyde Park New York Recruiting
Research Site New York New York Recruiting
Research Site The Bronx New York Recruiting
Research Site Valhalla New York Recruiting
Research Site Durham North Carolina Recruiting
Research Site Cincinnati Ohio Recruiting
Research Site Cleveland Ohio Recruiting
Research Site Columbus Ohio Recruiting
Research Site Portland Oregon Recruiting
Research Site Philadelphia Pennsylvania Recruiting
Research Site Greenville South Carolina Withdrawn
Research Site El Paso Texas Recruiting
Research Site Houston Texas Recruiting
Research Site Salt Lake City Utah Recruiting
Research Site Buenos Aires Argentina Withdrawn
Research Site Córdoba Argentina Recruiting
Research Site Rosario Argentina Recruiting
Research Site San Miguel de Tucumán Argentina Recruiting
Research Site Belo Horizonte Brazil Not Yet Recruiting
Research Site Belo Horizonte Brazil Not Yet Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Ribeirão Preto Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site Calgary British Columbia Not Yet Recruiting
Research Site Vancouver British Columbia Recruiting
Research Site Toronto Ontario Recruiting
Research Site Beijing China Withdrawn
Research Site Beijing China Not Yet Recruiting
Research Site Beijing China Recruiting
Research Site Changchun China Recruiting
Research Site Changsha China Recruiting

+ 63 more sites — see the full list on the official registry below.

On this site

📄 Saphnelo (anifrolumab) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05835310 on ClinicalTrials.gov ↗ ← All trials in the UK