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RecruitingPhase 2

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

CSL Behring · NCT07224360

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
63
US sites recruiting
9
Study start
February 2, 2026
Record last updated
August 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Anumigilimab; Placebo

Conditions: Sickle Cell Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Trial Registration Coordinator · +1 610-878-4697 · clinicaltrials@cslbehring.com
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease… (NCT07224360) | Bored Studies