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

NCT07224360 · tracked via the Priya Life Science UK tracker

Sponsor

CSL Behring

Phase

Phase 2

Started

2026-02-02

Last updated

2026-08-05

Condition(s) studied

Sickle Cell Disease

Investigational drug(s) / intervention(s)

AnumigilimabPlacebo

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

Placebo: Volume matched saline will be administered SC.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP) — From baseline up to Week 75
Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP — From baseline up to Week 75
Number of participants with Adverse Events of Special Interest (AESI) — From baseline up to Week 75
The following AEs are to be reported as AESI: neutropenia (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or 4), severe infection and neutropenic fever.
Percentage of participants with AESI — From baseline up to Week 75
The following AEs are to be reported as AESI: neutropenia (CTCAE Grade 3 or 4), severe infection and neutropenic fever.
Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs — From baseline up to Week 75
Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs — From baseline up to Week 75

Trial sites (16)

Facility	City	Region	Status
UAMS Medical Center	Little Rock	Arkansas	Recruiting
University of California Irvine	Orange	California	Recruiting
The Foundation for Sickle Cell Disease	Hollywood	Florida	Recruiting
Arthur M. Blank Hospital- Children's Healthcare of Atlanta	Atlanta	Georgia	Recruiting
Center for Cancer and Blood Disorders	Bethesda	Maryland	Recruiting
Southern Specialty Research	Flowood	Mississippi	Recruiting
Jacobi Medical Center	The Bronx	New York	Recruiting
Ohio State University	Columbus	Ohio	Recruiting
Virginia Commonwealth University	Richmond	Virginia	Recruiting
CHU Saint-Pierre	Brussels	Belgium	Recruiting
CHU de Nantes, Hotel-Dieu	Nantes	France	Recruiting
Institut Universitaire du Cancer de Toulouse	Toulou	France	Recruiting
AOUI Verona and University of Verona	Verona	Italy	Recruiting
Central Middlesex Hospital	London	United Kingdom	Recruiting
St George's University Hopsitals NHS Foundation Trust	London	United Kingdom	Recruiting
Hammersmith Hospital Imperial College Healthcare NHS Trust	London	United Kingdom	Recruiting

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Other trials for the same condition

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease Recruiting

A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP) Active, not recruiting

A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease Recruiting

A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia Recruiting

A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07224360 on ClinicalTrials.gov ↗ ← All trials in the UK