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

RecruitingPhase 2Ages 18 Years - anyAllCSL Behring
NCT07224360 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Anumigilimab
  • Placebo
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Where

16 sites
UAMS Medical Center
Little Rock, United States
University of California Irvine
Orange, United States
The Foundation for Sickle Cell Disease
Hollywood, United States
Arthur M. Blank Hospital- Children's Healthcare of Atlanta
Atlanta, United States
Center for Cancer and Blood Disorders
Bethesda, United States
Southern Specialty Research
Flowood, United States
Jacobi Medical Center
The Bronx, United States
Ohio State University
Columbus, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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