Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease

• Research type

  Research Study

• Full title

  Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease.

• IRAS ID

  1013260

• Contact name

  Study Director -

• Contact email

  clinicaltrials@cslbehring.com

• Sponsor organisation

  CSL Behring LLC

• Clinicaltrials.gov Identifier

  NCT07224360

• Research summary

  This is a Phase 2a, global research study taking place at multiple hospitals. The main goal of this study is to find out how safe and well-tolerated anumigilimab is in participants with sickle cell disease (SCD).
  The study also aims to:
  • Understand how anumigilimab is absorbed, distributed throughout, and removed from the body (this is called pharmacokinetics, or PK).
  • Assess the effect of anumigilimab on the frequency of vaso-occlusive crises (VOCs).
  Participants will be chosen at random (like flipping a coin) to receive either anumigilimab or a placebo (a dummy treatment that has no active medicine). Neither the participants nor the study doctors will know which treatment each person is getting until the study ends.
  Anumigilimab will be given as an injection under the skin once every two weeks. The total study lasts about 64 weeks (just over a year).
  • During the first 12 weeks (called the “dose escalation period”), doctors will slowly increase the dose for each person until they reach their maximum tolerated dose (MTD) — the highest dose that is safe and tolerable for them.
  • For the remaining 52 weeks (the “maintenance period”), participants will continue to receive that same safe dose.
  All participants will keep taking their usual treatments for sickle cell disease, such as hydroxyurea, L-glutamine, or crizanlizumab, if their doctor has prescribed them. The main focus is to check for any side effects or safety concerns. Researchers will also study how anumigilimab behaves in the body and whether it helps prevent painful crises. Participants will have more frequent safety checks and blood tests during the first 12 weeks while doses are being adjusted. These checks will happen less often during the maintenance period to make participation easier.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  26/LO/0133

• Date of REC Opinion

  5 Mar 2026

• REC opinion

  Further Information Favourable Opinion