RecruitingPhase 3

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

United States, Argentina, Brazil100 participantsStarted 2024-03-14

Plain-language 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)

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 speciali…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 3 trial specifically for children and teens with lupus, how does my child's age and disease severity compare to what this study is looking for, and is this the right stage of research for us to consider participating in?
2The trial is split into two parts — Part A focusing on how the drug moves through a child's body, and Part B measuring whether kids actually respond to treatment — where would my child likely fit in, and what does that mean for their experience in the study?
3Anifrolumab is already approved for adults with lupus, but this study is testing it specifically in pediatric patients — what do doctors currently know about its safety profile in adults, and what unknowns remain for children that this trial is trying to answer?
4Since the study involves intravenous infusions, how often would my child need to come in for treatments and monitoring, and is that level of commitment realistic given our schedule and location?
5Before considering this trial, should my child try standard lupus treatments first, or is there a reason this study might be worth discussing now given where we are in their diagnosis and treatment history?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A- Anifrolumab serum concentration

Timeframe: Pre-dose Day 29

Part A - Maximum observed serum (peak) drug concentration (Cmax)

Timeframe: Up to Day 29

Part A - Area under the serum concentration curve (AUC)

Timeframe: Up to Day 29

Part A - Minimum observed serum concentration (Cmin)

Timeframe: Up to Day 29

Part B - Number of participants who are British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responders (yes/no)

Timeframe: At Week 52

Trial details

NCT IDNCT05835310

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-05

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A- Anifrolumab serum concentration

Timeframe: Pre-dose Day 29

Part A - Maximum observed serum (peak) drug concentration (Cmax)

Timeframe: Up to Day 29

Part A - Area under the serum concentration curve (AUC)

Timeframe: Up to Day 29

Part A - Minimum observed serum concentration (Cmin)

Timeframe: Up to Day 29

Part B - Number of participants who are British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responders (yes/no)

Timeframe: At Week 52