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

Clinical Trial
Study Details
Enrollment
63
Interventions
Description

Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.

Name
Anumigilimab
Type
Biological
Description

Volume matched saline will be administered SC.

Name
Placebo
Type
Drug
Phase
Phase 2
Status
RECRUITING
Study ID #
NCT07224360
Study Type
Interventional
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.

Study Overview
Conditions
Contacts and Locations
Locations
Facility

UAMS Medical Center
Little Rock, Arkansas 72202
United States

GeoPoint
34.74648, -92.28959
Status
Recruiting
Facility

University of California Irvine
Orange, California 92868
United States

GeoPoint
33.78779, -117.85311
Status
Recruiting
Facility

The Foundation for Sickle Cell Disease
Hollywood, Florida 33023-6703
United States

GeoPoint
26.0112, -80.14949
Status
Recruiting
Facility

Arthur M. Blank Hospital- Children's Healthcare of Atlanta
Atlanta, Georgia 30329
United States

GeoPoint
33.749, -84.38798
Status
Recruiting
Facility

Center for Cancer and Blood Disorders
Bethesda, Maryland 20817
United States

GeoPoint
38.98067, -77.10026
Status
Recruiting
Facility

Southern Specialty Research
Flowood, Mississippi 39232
United States

GeoPoint
32.30959, -90.13898
Status
Recruiting
Facility

Jacobi Medical Center
The Bronx, New York 10461
United States

GeoPoint
40.84985, -73.86641
Status
Recruiting
Facility

Ohio State University
Columbus, Ohio 43210
United States

GeoPoint
39.96118, -82.99879
Status
Recruiting
Facility

Virginia Commonwealth University
Richmond, Virginia 23298
United States

GeoPoint
37.55376, -77.46026
Status
Recruiting
Facility

CHU Saint-Pierre
1000 Brussels
Belgium

GeoPoint
50.85045, 4.34878
Status
Recruiting
Facility

CHU de Nantes, Hotel-Dieu
44093 Nantes
France

GeoPoint
47.21725, -1.55336
Status
Recruiting
Facility

Institut Universitaire du Cancer de Toulouse
31100 Toulou
France

Status
Recruiting
Facility

AOUI Verona and University of Verona
37134 Verona
Italy

GeoPoint
45.43854, 10.9938
Status
Recruiting
Facility

Central Middlesex Hospital
London
NW10 7NS
United Kingdom

GeoPoint
51.50853, -0.12574
Status
Recruiting
Facility

St George's University Hopsitals NHS Foundation Trust
London
SW17 0QT
United Kingdom

GeoPoint
51.50853, -0.12574
Status
Recruiting
Facility

Hammersmith Hospital Imperial College Healthcare NHS Trust
London
W120HS
United Kingdom

GeoPoint
51.50853, -0.12574
Status
Recruiting