Safety of Anumigilimab in Adults With Sickle Cell Disease
Tests anumigilimab, given by injection, against placebo in adults with sickle cell disease.
Plain-language title generated from the registry record
Registry title: Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Key facts
- Where
- Ferrara, Genoa, Modena, Monza, Naples, Palermo, Rome, and Verona, ItalySee the 8 sites
- Phase
- Phase 2
Where in Italy
- University Hospital Of FerraraFerrara, ItalyTaking people
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyTaking people
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloPalermo, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
- Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CSL Behring
- Trial code
- NCT07224360EU 2025-521154-42-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease
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.
Inclusion: 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: If on SCD preventive medication, dose is not stable in the 30 days before Screening; Absolute neutrophil count less than (<) 2.5 ×10\^9 cells/Litre at Screening or Baseline (Week 1 Day 1).