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

{ "Safety of Anumigilimab for Sickle Cell Disease", "This study is looking at the safety of a drug called anumigilimab (CSL324) for adults with sickle cell disease (SCD). Researchers want to find the highest safe dose of anumigilimab. You might be able to join if you are an adult with SCD and have had 1 to 12 pain crises (VOCs) that needed medical attention in the past year. The study will compare anumigilimab to a placebo (an inactive substance like saline). The main goal is to see how many participants experience side effects and how serious they are. The study plans to enroll 63 participants.", "design": "This is a Phase 2a, global study that is randomized and double-blind, meaning neither you nor your doctor will know if you are receiving anumigilimab or placebo. It plans to enroll 63 participants.", "commitments": "You would receive treatment for 64 weeks, with the dose of anumigilimab adjusted during the first 12 weeks. You would then continue at your individual dose for another 52 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your safety will be monitored from the start of the study up to Week 75.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224360

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
CSL Behring
~63 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:AnumigilimabPlacebo

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP)
Measured over From baseline up to Week 75
+5 more outcomes measured

Conditions

Sickle Cell Disease

Explore related trials

Sickle Cell Disease

Where it's being run

16 sites across 13 states
United Kingdom3
France2
Arkansas1
California1
Florida1
Georgia1
Maryland1
Mississippi1

Study leadership

  • Study Director · STUDY_DIRECTOR · CSL Behring

Who to contact

Trial Registration Coordinator
[email protected]
+1 610-878-4697
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP)From baseline up to Week 75
  • Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IPFrom baseline up to Week 75
  • Number of participants with Adverse Events of Special Interest (AESI)From baseline up to Week 75

    The following AEs are to be reported as AESI: neutropenia (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or 4), severe infection and neutropenic fever.

  • Percentage of participants with AESIFrom baseline up to Week 75

    The following AEs are to be reported as AESI: neutropenia (CTCAE Grade 3 or 4), severe infection and neutropenic fever.

  • Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signsFrom baseline up to Week 75
  • Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signsFrom baseline up to Week 75