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

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NCT05835310 · readout in 778 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

100estimated

Sites

100

Countries

Argentina, Brazil, Canada +14

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2024-03-14

actual

When the study began enrolling

Primary completion

2028-10-05

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-01-09

estimated

The whole study's end, after follow-up

First posted

2023-04-28

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Systemic Lupus Erythematosus

Interventions

Biological: Anifrolumab — also filed as (MEDI-546)
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Part A- Anifrolumab serum concentration

measured Pre-dose Day 29

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

measured Up to Day 29

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

measured Up to Day 29

Part A - Minimum observed serum concentration (Cmin)

measured Up to Day 29

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

measured At Week 52

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