Anumigilimab for Sickle Cell Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called anumigilimab for individuals with sickle cell disease. The main goal is to determine if anumigilimab is safe when administered under the skin at the highest tolerable dose. Participants will have their dose increased over 12 weeks, followed by a continuation at this dose for another 52 weeks. Eligible participants must have a confirmed diagnosis of sickle cell disease and have experienced 1 to 12 pain crises requiring medical treatment in the past year. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that anumigilimab is likely to be safe for humans?
A previous study tested anumigilimab in adults with sickle cell disease (SCD) to assess its safety. This research remains in an early stage, so scientists are still determining the treatment's safety and tolerability. The study aims to identify the highest dose that people can take without serious side effects. For those considering joining a trial, this information highlights that safety is a top priority, though more research is needed to fully understand the risks.12345
Why do researchers think this study treatment might be promising for sickle cell disease?
Anumigilimab is unique because it offers a novel approach to managing Sickle Cell Disease (SCD) by targeting the underlying inflammation that contributes to the disease's complications. Unlike current standard treatments, like hydroxyurea or blood transfusions, which focus on reducing sickle cell formation or managing symptoms, Anumigilimab acts by modulating the immune response, potentially reducing pain crises and organ damage. Researchers are particularly excited about this treatment because it represents a targeted therapy with the potential for fewer side effects and improved quality of life for patients with SCD.
What evidence suggests that anumigilimab might be an effective treatment for sickle cell disease?
Research has shown that anumigilimab, which participants in this trial may receive, blocks signals that cause inflammation and pain in sickle cell disease (SCD). In animal studies, this treatment reduced harmful cell activities. It specifically targets neutrophils, cells that can cause inflammation and damage in SCD. By reducing these harmful effects, anumigilimab may help manage pain and other symptoms of the disease. Although research in humans is ongoing, its mechanism suggests potential benefits for people with SCD.12467
Who Is on the Research Team?
Study Director
Principal Investigator
CSL Behring
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive anumigilimab with dose escalation to determine individual maximum tolerated dose (MTD)
Maintenance
Participants receive anumigilimab at the determined MTD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anumigilimab
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD)
Participants will receive matching volume of placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CSL Behring
Lead Sponsor
Dr. Paul McKenzie
CSL Behring
Chief Executive Officer since 2023
PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania
Dr. Bill Mezzanotte
CSL Behring
Chief Medical Officer since 2021
MD from Duke University
Citations
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell ...
The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.
2.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT07224360/safety-of-anumigilimab-csl324-in-adults-with-sickle-cell-disease-scdSafety of Anumigilimab (CSL324) in Adults With Sickle Cell ...
This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab ...
3.
pharmaceutical-technology.com
pharmaceutical-technology.com/data-insights/anumigilimab-csl-sickle-cell-disease-likelihood-of-approval/Anumigilimab by CSL for Sickle Cell Disease: Likelihood of ...
Anumigilimab is under clinical development by CSL and currently in Phase I for Sickle Cell Disease. According to GlobalData, Phase I drugs for Sickle Cell ...
Recent Advances in Sickle-Cell Disease Therapies - PMC - NIH
The objective of this article is to evaluate post-approval studies of crizanlizumab, voxelotor, and L-glutamine in SCD, with a focus on real-world efficacy, ...
anumigilimab (CSL324) / CSL Behring
... sickle cell disease: Target for a new phase 2 trial (ASH 2025) - "CSL324 was safe and welltolerated in repeat-dose toxicological studies in non-human ...
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell ...
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 ...
7.
clinicaltrials.eu
clinicaltrials.eu/trial/a-study-to-assess-the-safety-of-anumigilimab-in-adults-with-sickle-cell-disease/A study to assess the safety of Anumigilimab in adults ...
This study focuses on individuals living with Sickle Cell Disease, a condition that affects red blood cells, causing them to become misshapen like a ...
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