Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07224360

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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