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NCT07224360RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
63 (estimated)
First submitted
31 Oct 2025
Start date
2 Feb 2026
Primary completion date
15 Aug 2028
Lead sponsor
CSL Behring
NCT number
NCT07224360
EU CT number
2025-521154-42-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 63
  • From 2 Feb 2026 to the primary completion date, 15 Aug 2028
  • 40 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Lab values

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

Who the study is looking for

  • Adults aged greater than or equal to (\>=) 18 years on the day of signing the informed consent form.
  • Confirmed diagnosis of SCD of any genotype.
  • Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening.
  • HU Regimen:
  • a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening.
  • or
  • b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Saint-Pierre
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
Coordinator of this site? Confirm its status
EdegemBelgiumRecruiting
Centre Hospitalier Regional De Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Centre Hospitalier Universitaire Rouen
Coordinator of this site? Confirm its status
Rouen CedexFranceRecruiting
Oncopole Claudius Regaud
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Royal Liverpool University Hospital
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomRecruiting
Central Middlesex Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Royal London Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
St George's University Hopsitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Guy's Hospital
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LondonUnited KingdomRecruiting
Manchester Royal Infirmary
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ManchesterUnited KingdomRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
IRCCS Istituto Giannina Gaslini
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GenoaItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
Coordinator of this site? Confirm its status
ModenaItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyRecruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Coordinator of this site? Confirm its status
PalermoItalyRecruiting
Ospedale Pediatrico Bambino Gesù
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Centro Ricerche Cliniche di Verona s.r.l.
Coordinator of this site? Confirm its status
VeronaItalyRecruiting
Amsterdam UMC Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Arthur M Blank Hospital - Children's Healthcare of Atlanta
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AtlantaUnited StatesRecruiting
Center for Cancer and Blood Disorders
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BethesdaUnited StatesRecruiting
Boston Medical Center
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BostonUnited StatesRecruiting
Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Southern Specialty Research
Coordinator of this site? Confirm its status
FlowoodUnited StatesRecruiting
The Foundation for Sickle Cell Disease
Coordinator of this site? Confirm its status
HollywoodUnited StatesRecruiting
UT Physicians Comprehensive Adult Sickle Cell Center
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HoustonUnited StatesRecruiting
NYC Health + Hospitals/Queens
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JamaicaUnited StatesRecruiting
UAMS Medical Center
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Little RockUnited StatesRecruiting
University of Minnesota
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MinneapolisUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
University of California Irvine
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OrangeUnited StatesRecruiting
Virginia Commonwealth University
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RichmondUnited StatesRecruiting
Jacobi Medical Center
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The BronxUnited StatesRecruiting
Acibadem Adana Hastanesi
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Recruiting
Hacettepe University Medical Faculty
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
VM Medical Park Mersin Hospital
Coordinator of this site? Confirm its status
MezitliTurkey (Türkiye)Recruiting
Mersin University Medical Faculty
Coordinator of this site? Confirm its status
YenişehirTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.