NCT07224360 · CSL Behring
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
What this study is about
This is a phase 2a, global, conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study investigating the safety of anumigilimab administered injected under the skin (SC) at the maximum tolerated dose (MTD) in adult participants with SCD.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
Where
- Little Rock, Arkansas
- Hollywood, Florida
- Bethesda, Maryland
- Flowood, Mississippi
- The Bronx, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations