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Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Adults aged greater than or equal to (\>=) 18 years on the day of signing the informed consent form. * Confirmed diagnosis of SCD of any genotype. * Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening. * HU Regimen: * a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening. * or * b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect). Exclusion Criteria: * Absolute neutrophil count less than (\<) 2.5 ×10\^9 cells/Litre at Screening or Baseline (Week 1 Day 1). * If on SCD preventive medication, dose is not stable in the 30 days before Screening.
About the study
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.
What is being tested
- Anumigilimab (biological)
- Placebo (drug)
Sponsor: CSL Behring · Participants: 63 · Started: Feb 2, 2026
Contact the study team
- Trial Registration Coordinator · Phone: +1 610-878-4697
Official record on ClinicalTrials.gov — NCT07224360
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.