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

Last updated: May 11, 2026
Sponsor: CSL Behring
Overall Status: Active - Recruiting

Phase

2

Condition

Red Blood Cell Disorders

Sickle Cell Disease

Anemia

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 treatmentwith parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug withinthe 12 months 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 beforeScreening.

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

Connect with a study center

  • UAMS Medical Center

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • The Foundation for Sickle Cell Disease

    Hollywood, Florida 33023-6703
    United States

    Active - Recruiting

  • The Foundation for Sickle Cell Disease

    Hollywood 4158928, Florida 4155751 33023-6703
    United States

    Site Not Available

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Southern Specialty Research

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Southern Specialty Research

    Flowood 4426822, Mississippi 4436296 39232
    United States

    Site Not Available

  • Jacobi Medical Center

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Jacobi Medical Center

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.