An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Part A- Anifrolumab serum concentration — Pre-dose Day 29
The serum concentration will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severely active SLE. - Part A - Maximum observed serum (peak) drug concentration (Cmax) — Up to Day 29
The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severely active SLE. - Part A - Area under the serum concentration curve (AUC) — Up to Day 29
The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severe active SLE. - Part A - Minimum observed serum concentration (Cmin) — Up to Day 29
The serum PK will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severe active SLE. - Part B - Number of participants who are British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responders (yes/no) — At Week 52
BICLA response is defined as: * Reduction of all baseline British Isles Lupus Assessment Group BILAG-2004 A to B/C/D and B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG- 2004 B. * No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), defined as an increase from baseline of \> 0 points. * No worsening from baseline in participant's lupus disease activity, defined by an increase ≥ 0.30 points on a Physician's Global Assessment (PGA) 3-point visual analogue scale (VAS).
Trial sites (103)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Alberta | 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 Spain
Other trials for the same condition
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 Spain