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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT07224360

Run by

CSL Behring

People needed

63

Starts

2026-02-02

Expected to finish

2028-06-29

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UAMS Medical Center — Little Rock, Arkansas, United States (enrolling)
• University of California Irvine — Orange, California, United States (enrolling)
• The Foundation for Sickle Cell Disease — Hollywood, Florida, United States (enrolling)
• Arthur M. Blank Hospital- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States (enrolling)
• Southern Specialty Research — Flowood, Mississippi, United States (enrolling)
• Jacobi Medical Center — The Bronx, New York, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• CHU Saint-Pierre — Brussels, Belgium (enrolling)
• CHU de Nantes, Hotel-Dieu — Nantes, France (enrolling)
• Institut Universitaire du Cancer de Toulouse — Toulou, France (enrolling)
• AOUI Verona and University of Verona — Verona, Italy (enrolling)
• Central Middlesex Hospital — London, United Kingdom (enrolling)
• St George's University Hopsitals NHS Foundation Trust — London, United Kingdom (enrolling)
• Hammersmith Hospital Imperial College Healthcare NHS Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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