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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835310
The ClinicalTrials.gov registry entry for NCT05835310 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (74% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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