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NCT07224360PHASE2Recruiting

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

CSL Behring

Start Date

2/2/2026

Completion Date

6/29/2028

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 Criteria

Age Range: 18 years to No maximum

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. * or * 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.

Interventions

BIOLOGICAL

Anumigilimab

DRUG

Placebo

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Conditions

Sickle Cell Disease

Locations

UAMS Medical Center

Little Rock, Arkansas 72202

United States

University of California Irvine

Orange, California 92868

United States

The Foundation for Sickle Cell Disease

Hollywood, Florida 33023-6703

United States

Arthur M. Blank Hospital- Children's Healthcare of Atlanta

Atlanta, Georgia 30329

United States

Center for Cancer and Blood Disorders

Bethesda, Maryland 20817

United States

Southern Specialty Research

Flowood, Mississippi 39232

United States

Jacobi Medical Center

The Bronx, New York 10461

United States

Ohio State University

Columbus, Ohio 43210

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States

CHU Saint-Pierre

Brussels, 1000

Belgium

CHU de Nantes, Hotel-Dieu

Nantes, 44093

France

Institut Universitaire du Cancer de Toulouse

Toulou, 31100

France

AOUI Verona and University of Verona

Verona, 37134

Italy

Central Middlesex Hospital

London, NW10 7NS

United Kingdom

St George's University Hopsitals NHS Foundation Trust

London, SW17 0QT

United Kingdom

Hammersmith Hospital Imperial College Healthcare NHS Trust

London, W120HS

United Kingdom