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

Last updated: August 4, 2026
Sponsor: CSL Behring
Overall Status: Active - Recruiting

Phase

2

Condition

Anemia

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Anumigilimab

Placebo

Clinical Study ID

NCT07224360
CSL324_2002
2025-521154-42-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged greater than or equal to (>=) 18 years on the day of signing theinformed consent form.

  • Confirmed diagnosis of SCD of any genotype.

  • Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment withparenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12months before Screening.

  • HU Regimen:

  • a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days beforeScreening.

  • or

  • b. HU was discontinued or refused (eg, due to concern of side effects or lack ofeffect).

Exclusion

Exclusion Criteria:

  • Absolute neutrophil count less than (<) 2.5 ×10^9 cells/Litre at Screening orBaseline (Week 1 Day 1).

  • If on SCD preventive medication, dose is not stable in the 30 days before Screening.

Study Design

Total Participants: 63
Treatment Group(s): 2
Primary Treatment: Anumigilimab
Phase: 2
Study Start date:
February 02, 2026
Estimated Completion Date:
June 29, 2028