Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
ConditionSickle Cell Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSL Behring
About this trial
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.
Eligibility criteria
Qualifiers
• 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.
a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening.
Disqualifiers
• 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.
Trial design
Treatments tested in this trial
- Anumigilimab
- Placebo
Treatment groups
63 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov