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Clinical Trials in the UK / NCT07224360
Recruiting Phase 2

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

NCT07224360 · tracked via the Priya Life Science UK tracker
Sponsor
CSL Behring
Phase
Phase 2
Started
2026-02-02
Last updated
2026-08-05

Condition(s) studied

Sickle Cell Disease

Investigational drug(s) / intervention(s)

AnumigilimabPlacebo

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.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * Absolute neutrophil count less than (\<) 2.5 ×10\^9 cells/Litre at Screening or Baseline (Week 1 Day 1). * If on SCD preventive medication, dose is not stable in the 30 days before Screening.

Primary outcome measure(s)

  • Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP) — From baseline up to Week 75
  • Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP — From baseline up to Week 75
  • Number of participants with Adverse Events of Special Interest (AESI) — From baseline up to Week 75
    The following AEs are to be reported as AESI: neutropenia (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or 4), severe infection and neutropenic fever.
  • Percentage of participants with AESI — From baseline up to Week 75
    The following AEs are to be reported as AESI: neutropenia (CTCAE Grade 3 or 4), severe infection and neutropenic fever.
  • Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs — From baseline up to Week 75
  • Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs — From baseline up to Week 75

Trial sites (16)

FacilityCityRegionStatus
UAMS Medical Center Little Rock Arkansas Recruiting
University of California Irvine Orange California Recruiting
The Foundation for Sickle Cell Disease Hollywood Florida Recruiting
Arthur M. Blank Hospital- Children's Healthcare of Atlanta Atlanta Georgia Recruiting
Center for Cancer and Blood Disorders Bethesda Maryland Recruiting
Southern Specialty Research Flowood Mississippi Recruiting
Jacobi Medical Center The Bronx New York Recruiting
Ohio State University Columbus Ohio Recruiting
Virginia Commonwealth University Richmond Virginia Recruiting
CHU Saint-Pierre Brussels Belgium Recruiting
CHU de Nantes, Hotel-Dieu Nantes France Recruiting
Institut Universitaire du Cancer de Toulouse Toulou France Recruiting
AOUI Verona and University of Verona Verona Italy Recruiting
Central Middlesex Hospital London United Kingdom Recruiting
St George's University Hopsitals NHS Foundation Trust London United Kingdom Recruiting
Hammersmith Hospital Imperial College Healthcare NHS Trust London United Kingdom Recruiting

More CSL Behring trials in the UK

A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE) Recruiting
Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies Recruiting
Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222) Enrolling by invitation
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis Active, not recruiting
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis Recruiting

Other trials for the same condition

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease Recruiting
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia Recruiting
Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD) Active, not recruiting
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS) Active, not recruiting
PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS] Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07224360 on ClinicalTrials.gov ↗ ← All trials in the UK