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Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sponsor: CSL Behring
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.
Official title: Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2026-02-02
Completion Date
2028-08-15
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Anumigilimab
Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.
Placebo
Volume matched saline will be administered SC.
Locations (38)
UAMS Medical Center
Little Rock, Arkansas, United States
University of California Irvine
Orange, California, United States
The Foundation for Sickle Cell Disease
Hollywood, Florida, United States
Arthur M. Blank Hospital- Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Southern Specialty Research
Flowood, Mississippi, United States
NYC Health + Hospitals/Queens
Jamaica, New York, United States
Columbia University Medical Center
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Ohio State University
Columbus, Ohio, United States
UT Physicians Comprehensive Adult Sickle Cell Center
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
UZ Antwerpen
Edegem, Antwerp, Belgium
CHU Saint-Pierre
Brussels, Belgium
AP-HM Hôpital de La Timone
Marseille, Bouches-du-Rhône, France
CHU de Nantes, Hotel-Dieu
Nantes, France
CHU de Rouen-Hôpital Charles-Nicolle
Rouen, France
Institut Universitaire du Cancer de Toulouse
Toulou, France
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
Cona, Ferrara, Italy
IRCCS Istituto Giannina Gaslini
Genoa, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
AORN Antonio Cardarelli
Naples, Italy
IRCCS Bambino Gesù Children's Hospital
Rome, Italy
AOUI Verona and University of Verona
Verona, Italy
Amsterdam UMC - VUmc
Amsterdam, North Holland, Netherlands
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye)
Mersin University Medical Faculty
Yenişehir, Mersin, Turkey (Türkiye)
Acibadem Adana Hastanesi
Adana, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Manchester Royal Infirmary
Manchester, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
The Royal London Hospital
London, United Kingdom
Central Middlesex Hospital
London, United Kingdom
Guy's Hospital
London, United Kingdom
St George's University Hopsitals NHS Foundation Trust
London, United Kingdom
Hammersmith Hospital Imperial College Healthcare NHS Trust
London, United Kingdom