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Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 5 → 16 locations Eligibility criteria shortened, about 6 wordsv4 Show 1 more changeShow less
    • Eligibility criteria shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 3 to 5v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Nov 15, 2025 to Feb 2, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Nov 15, 2025 to Feb 2, 2026
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD. The primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period.
Trial Details
NCT Number NCT07224360
Lead Sponsor CSL Behring
Conditions Sickle Cell Disease
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov