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

Last updated: November 2, 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
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:
August 15, 2028

Connect with a study center

  • UZ Antwerpen

    Edegem, Antwerp 2650
    Belgium

    Active - Recruiting

  • CHU Saint-Pierre

    Brussels, 1000
    Belgium

    Active - Recruiting

  • AP-HM Hôpital de La Timone

    Marseille, Bouches-du-Rhône 13005
    France

    Active - Recruiting

  • CHU de Nantes, Hotel-Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • CHU de Rouen-Hôpital Charles-Nicolle

    Rouen, 76000
    France

    Active - Recruiting

  • Institut Universitaire du Cancer de Toulouse

    Toulou, 31100
    France

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna

    Cona, Ferrara 44124
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genoa, 16132
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900
    Italy

    Active - Recruiting

  • AORN Antonio Cardarelli

    Naples, 80131
    Italy

    Active - Recruiting

  • IRCCS Bambino Gesù Children's Hospital

    Rome, 00165
    Italy

    Active - Recruiting

  • AOUI Verona and University of Verona

    Verona, 37134
    Italy

    Active - Recruiting

  • Amsterdam UMC - VUmc

    Amsterdam, North Holland 1105AZ
    Netherlands

    Active - Recruiting

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin 33000
    Turkey (Türkiye)

    Active - Recruiting

  • Mersin University Medical Faculty

    Yenişehir, Mersin 33110
    Turkey (Türkiye)

    Active - Recruiting

  • Acibadem Adana Hastanesi

    Adana, 1130
    Turkey (Türkiye)

    Active - Recruiting

  • Hacettepe University Medical Faculty

    Ankara, 6230
    Turkey (Türkiye)

    Active - Recruiting

  • Manchester Royal Infirmary

    Manchester, England M13 9WL
    United Kingdom

    Active - Recruiting

  • Royal Liverpool University Hospital

    Liverpool, L7 8YE
    United Kingdom

    Active - Recruiting

  • Central Middlesex Hospital

    London, NW10 7NS
    United Kingdom

    Active - Recruiting

  • Guy's Hospital

    London, SE17EH
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital Imperial College Healthcare NHS Trust

    London, W120HS
    United Kingdom

    Active - Recruiting

  • St George's University Hopsitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • The Royal London Hospital

    London, E1 2ES
    United Kingdom

    Active - Recruiting

  • UAMS Medical Center

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • The Foundation for Sickle Cell Disease

    Hollywood, Florida 33023-6703
    United States

    Active - Recruiting

  • Arthur M. Blank Hospital- Children's Healthcare of Atlanta

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Southern Specialty Research

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • NYC Health + Hospitals/Queens

    Jamaica, New York 11432
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Jacobi Medical Center

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • UT Physicians Comprehensive Adult Sickle Cell Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

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