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
- Diseases
- Sickle cell disease
- 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
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Central Middlesex Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St George's University Hopsitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Arthur M Blank Hospital - Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Center for Cancer and Blood Disorders Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Southern Specialty Research Coordinator of this site? Confirm its status | Flowood | United States | Recruiting |
| The Foundation for Sickle Cell Disease Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| UT Physicians Comprehensive Adult Sickle Cell Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| NYC Health + Hospitals/Queens Coordinator of this site? Confirm its status | Jamaica | United States | Recruiting |
| UAMS Medical Center Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Jacobi Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Acibadem Adana Hastanesi Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Hacettepe University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| VM Medical Park Mersin Hospital Coordinator of this site? Confirm its status | Mezitli | Turkey (Türkiye) | Recruiting |
| Mersin University Medical Faculty Coordinator of this site? Confirm its status | Yenişehir | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.