Actively Recruiting
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Led by CSL Behring · Updated on 2026-05-12
63
Participants Needed
5
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at consent
- Confirmed diagnosis of sickle cell disease of any genotype
- Experienced 1 to 12 vaso-occlusive crises requiring medical treatment with parenteral opioids or nonsteroidal anti-inflammatory drugs within the 12 months before screening
- On a stable and well-tolerated hydroxyurea regimen for at least 30 days before screening or hydroxyurea was discontinued or refused
You will not qualify if you...
- Absolute neutrophil count less than 2.5 x 10^9 cells per liter at screening or baseline
- Unstable dose of sickle cell disease preventive medication within 30 days before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
UAMS Medical Center
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
The Foundation for Sickle Cell Disease
Hollywood, Florida, United States, 33023-6703
Actively Recruiting
3
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Actively Recruiting
4
Southern Specialty Research
Flowood, Mississippi, United States, 39232
Actively Recruiting
5
Jacobi Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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