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Recruiting Phase 2

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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.

Condition
Sickle Cell Disease
Tested
Anumigilimab, Placebo
Sponsor
CSL Behring

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Study condition: Sickle Cell Disease
  • 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 2

  • 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

16 sites, 16 recruiting

CHU Saint-Pierre

Brussels, Belgium

Recruiting

CHU de Nantes, Hotel-Dieu

Nantes, France

Recruiting

Institut Universitaire du Cancer de Toulouse

Toulou, France

Recruiting

AOUI Verona and University of Verona

Verona, Italy

Recruiting

Central Middlesex Hospital

London, United Kingdom

Recruiting

St George's University Hopsitals NHS Foundation Trust

London, United Kingdom

Recruiting

and 10 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.