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A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Primary endpoints: details revised at 1 of 5 entries · Trial sites expanded: 0 → 32 locations · Primary completion date: Sep 3, 2030 to Sep 2, 2030 · 3 more Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 5 entries
    • Trial sites expanded: 0 → 32 locations
    • Primary completion date: Sep 3, 2030 to Sep 2, 2030
    • Start date changed from estimate of Jul 28, 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 21 words
    • Study description expanded, about 5 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.
Trial Details
NCT Number NCT07630714
Lead Sponsor AstraZeneca
Conditions Systemic Lupus Erythematosus
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov