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

a study on Sickle Cell Anemia Anemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

Description

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.

Official Title

Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease

Keywords

Sickle Cell Disease, Anemia, Genetic Disorder, Vaso-occlusive Crises, Sickle Cell Anemia, Inborn Genetic Diseases, Anumigilimab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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:
    1. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening.
  • or
    1. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).

You CAN'T join if...

  • Absolute neutrophil count less than (<) 2.5 ×109 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.

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • UAMS Medical Center accepting new patients
    Little Rock Arkansas 72202 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT07224360
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 63 study participants
Last Updated
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