Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) (NCT07224360) | Clinical Trial Compass
RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
United States63 participantsStarted 2026-02-02
Plain-language summary
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
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* or
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP)
Timeframe: From baseline up to Week 75
2
Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP
Timeframe: From baseline up to Week 75
3
Number of participants with Adverse Events of Special Interest (AESI)
Timeframe: From baseline up to Week 75
4
Percentage of participants with AESI
Timeframe: From baseline up to Week 75
5
Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs
Timeframe: From baseline up to Week 75
6
Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs