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RECRUITING Phase 3

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

NCT05835310 · View on ClinicalTrials.gov ↗

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)

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

FieldValue
Enrollment Target 100 participants
Start Date 2024-03-14
Est. Completion 2030-01-09
Phase Phase 3

Sponsor

AstraZeneca

1,053 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05835310 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Ohio, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05835310?

The interventions under investigation include: Placebo (DRUG), Anifrolumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05835310?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial