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NCT05835310 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05835310: Recruiting Phase 3 study of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
NCT05835310 is a Phase 3 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 100 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05835310, a Phase 3 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
The serum concentration will be characterised and the dose of anifrolumab will be defined in pediatric participants with moderate to severely active SLE.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Anifrolumab
Study Locations (20)
New York
- Research Site - New Hyde Park
- Research Site - New York
- Research Site - The Bronx
- Research Site - Valhalla
Ohio
- Research Site - Cincinnati
- Research Site - Cleveland
- Research Site - Columbus
Illinois
- Research Site - Chicago
- Research Site - Chicago
Arizona
- Research Site - Phoenix
California
- Research Site - Los Angeles
District of Columbia
- Research Site - Washington D.C.
Louisiana
- Research Site - New Orleans
Maryland
- Research Site - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-14 |
| Est. Completion | 2030-01-09 |
| Phase | Phase 3 |
What NCT05835310 shows while recruiting
NCT05835310 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05835310 names 20 study sites across 14 states, led by New York, Ohio, Illinois.
Frequently Asked Questions
What is clinical trial NCT05835310 about?
NCT05835310 is a clinical study titled "An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants". 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)
What is the current status of trial NCT05835310?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2024-03-14. Estimated completion is 2030-01-09.
What conditions does trial NCT05835310 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT05835310?
The interventions under investigation include: Placebo (DRUG), Anifrolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05835310?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835310 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05835310's enrollment target sits among peer trials
100 55th of 99 higher than 44 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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