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Recruiting NCT07224360

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

Phase II Interventional Sickle Cell Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anumigilimab, Placebo.
Who it may be relevant to
Registry conditions: Sickle Cell Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, France, Italy, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease

Overview

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.

Interventions

  • Biological Anumigilimab
    Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.
  • Drug Placebo
    Volume matched saline will be administered SC.

Primary outcome measures

  • Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP) [Time frame: From baseline up to Week 75]
  • Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP [Time frame: From baseline up to Week 75]
  • Number of participants with Adverse Events of Special Interest (AESI) [Time frame: From baseline up to Week 75]
  • Percentage of participants with AESI [Time frame: From baseline up to Week 75]
  • Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs [Time frame: From baseline up to Week 75]
  • Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs [Time frame: From baseline up to Week 75]
Secondary outcome measures (2)
  • Serum concentration of Anumigilimab [Time frame: From the first dose of anumigilimab to Week 65]
  • Annualized rate of Vaso-occlusive crisis (VOC) (medical facility) [Time frame: During the maintenance period from Week 13 to Week 65]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 9 centers
  • UAMS Medical Center — Little Rock
  • University of California Irvine — Orange
  • The Foundation for Sickle Cell Disease — Hollywood
  • Arthur M. Blank Hospital- Children's Healthcare of Atlanta — Atlanta
  • Center for Cancer and Blood Disorders — Bethesda
  • Southern Specialty Research — Flowood
  • Jacobi Medical Center — The Bronx
  • Ohio State University — Columbus
  • … and 1 more center
United Kingdom · 3 centers
  • Central Middlesex Hospital — London
  • St George's University Hopsitals NHS Foundation Trust — London
  • Hammersmith Hospital Imperial College Healthcare NHS Trust — London
France · 2 centers
  • CHU de Nantes, Hotel-Dieu — Nantes
  • Institut Universitaire du Cancer de Toulouse — Toulou
Belgium · 1 center
  • CHU Saint-Pierre — Brussels
Italy · 1 center
  • AOUI Verona and University of Verona — Verona

Identifiers

NCT: NCT07224360 · CSL324_2002 · 2025-521154-42-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗