Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arkansas
UAMS Medical Center
RECRUITING
Little Rock
California
University of California Irvine
RECRUITING
Orange
Florida
The Foundation for Sickle Cell Disease
RECRUITING
Hollywood
Georgia
Arthur M. Blank Hospital- Children's Healthcare of Atlanta
RECRUITING
Atlanta
Maryland
Center for Cancer and Blood Disorders
RECRUITING
Bethesda
Mississippi
Southern Specialty Research
RECRUITING
Flowood
New York
Jacobi Medical Center
RECRUITING
The Bronx
Ohio
Ohio State University
RECRUITING
Columbus
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Belgium
CHU Saint-Pierre
RECRUITING
Brussels
France
CHU de Nantes, Hotel-Dieu
RECRUITING
Nantes
Institut Universitaire du Cancer de Toulouse
RECRUITING
Toulou
Italy
AOUI Verona and University of Verona
RECRUITING
Verona
United Kingdom
Central Middlesex Hospital
RECRUITING
London
Hammersmith Hospital Imperial College Healthcare NHS Trust
RECRUITING
London
St George's University Hopsitals NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Trial Registration Coordinator
clinicaltrials@cslbehring.com
+1 610-878-4697
Time Frame
Start Date:2026-02-02
Estimated Completion Date:2028-06-29
Participants
Target number of participants:63
Treatments
Experimental: Anumigilimab
Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD)
Placebo_comparator: Placebo
Participants will receive matching volume of placebo.