Sickle Cell Disease

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

NCT07224360 | PHASE 2 | INTERVENTIONAL

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.

16 Sites

63 Participants

RECRUITING

18 Years

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Find closest sites:

SUBMIT

UAMS Medical Center

Little Rock,Arkansas,United States,72202

University of California Irvine

Orange,California,United States,92868

The Foundation for Sickle Cell Disease

Hollywood,Florida,United States,33023

Arthur M. Blank Hospital Children's Healthcare of Atlanta

Atlanta,Georgia,United States,30329

Center for Cancer and Blood Disorders

Bethesda,Maryland,United States,20817

Southern Specialty Research

Flowood,Mississippi,United States,39232

Jacobi Medical Center

The Bronx,New York,United States,10461

Ohio State University

Columbus,Ohio,United States,43210

Virginia Commonwealth University

Richmond,Virginia,United States,23298

CHU SaintPierre

Brussels,Virginia,Belgium,1000

CHU de Nantes, HotelDieu

Nantes,Virginia,France,44093

Institut Universitaire du Cancer de Toulouse

Toulou,Virginia,France,31100

AOUI Verona and University of Verona

Verona,Virginia,Italy,37134

Central Middlesex Hospital

London,Virginia,United Kingdom,NW107NS

St George's University Hopsitals NHS Foundation Trust

London,Virginia,United Kingdom,SW170QT

Hammersmith Hospital Imperial College Healthcare NHS Trust

London,Virginia,United Kingdom,W120HS

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov