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

ClinicalTrials.gov ID: NCT05835310

Public ClinicalTrials.gov record NCT05835310. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 7, 2026, 9:03 AM EDT

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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 While on Background Standard of Care Therapy

Study identification

NCT ID: NCT05835310
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AstraZeneca; Industry
Enrollment: 100 participants

Conditions and interventions

Conditions

Systemic Lupus Erythematosus

Interventions

Anifrolumab Biological
Placebo Drug

Biological · Drug

Eligibility (public fields only)

Age range: 5 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 13, 2024
Primary completion: Oct 4, 2028
Completion: Jan 8, 2030
Last update posted: May 5, 2026

2024 – 2030

United States locations

U.S. sites: 22
U.S. states: 15
U.S. cities: 21

Facility	City	State	ZIP	Site status
Research Site	Phoenix	Arizona	85016	Recruiting
Research Site	Los Angeles	California	90027	Recruiting
Research Site	Washington D.C.	District of Columbia	20010	Recruiting
Research Site	Chicago	Illinois	60611	Recruiting
Research Site	Chicago	Illinois	60637	Recruiting
Research Site	New Orleans	Louisiana	70118	Not yet recruiting
Research Site	Bethesda	Maryland	20889	Withdrawn
Research Site	Saint Paul	Minnesota	55125	Recruiting
Research Site	New Hyde Park	New York	11042	Recruiting
Research Site	New York	New York	10032	Recruiting
Research Site	The Bronx	New York	10467	Recruiting
Research Site	Valhalla	New York	10595	Recruiting
Research Site	Durham	North Carolina	27710	Recruiting
Research Site	Cincinnati	Ohio	45229	Recruiting
Research Site	Cleveland	Ohio	44109	Recruiting
Research Site	Columbus	Ohio	43203	Recruiting
Research Site	Portland	Oregon	97227	Recruiting
Research Site	Philadelphia	Pennsylvania	19104	Recruiting
Research Site	Greenville	South Carolina	29605	Withdrawn
Research Site	El Paso	Texas	79902	Recruiting
Research Site	Houston	Texas	77030	Recruiting
Research Site	Salt Lake City	Utah	84108	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05835310, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 5, 2026 · Synced May 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05835310 live on ClinicalTrials.gov.

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