Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Recruiting · NCT07224360 · Interventional (participants receive a specific treatment) · Lead sponsor: CSL Behring
View the official record on ClinicalTrials.gov →Interventions studied
AnumigilimabPlacebo
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
- 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.
Where it is running
16 locations listed across 9 US states.
- UAMS Medical Center - Little Rock, Arkansas, United States
- University of California Irvine - Orange, California, United States
- The Foundation for Sickle Cell Disease - Hollywood, Florida, United States
- Arthur M. Blank Hospital- Children's Healthcare of Atlanta - Atlanta, Georgia, United States
- Center for Cancer and Blood Disorders - Bethesda, Maryland, United States
- Southern Specialty Research - Flowood, Mississippi, United States
- Jacobi Medical Center - The Bronx, New York, United States
- Ohio State University - Columbus, Ohio, United States
- Virginia Commonwealth University - Richmond, Virginia, United States
- CHU Saint-Pierre - Brussels, Belgium
- Central Middlesex Hospital - London, United Kingdom
- St George's University Hopsitals NHS Foundation Trust - London, United Kingdom
- Hammersmith Hospital Imperial College Healthcare NHS Trust - London, United Kingdom
- CHU de Nantes, Hotel-Dieu - Nantes, France
- Institut Universitaire du Cancer de Toulouse - Toulou, France
- AOUI Verona and University of Verona - Verona, Italy