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NCT Number: NCT07224360

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Vaso-Occlusive Crises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UAMS Medical Center, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anumigilimab

Biological

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

Placebo

Drug

Volume matched saline will be administered SC.

Primary outcomes

  1. 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

  2. Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP

    Time frame: From baseline up to Week 75

  3. Number of participants with Adverse Events of Special Interest (AESI)

    Time frame: 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.

  4. Percentage of participants with AESI

    Time frame: 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.

  5. Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs

    Time frame: From baseline up to Week 75

  6. Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs

    Time frame: From baseline up to Week 75

Secondary outcomes

  1. Serum concentration of Anumigilimab

    Time frame: From the first dose of anumigilimab to Week 65

  2. Annualized rate of Vaso-occlusive crisis (VOC) (medical facility)

    Time frame: During the maintenance period from Week 13 to Week 65

    VOC (medical facility) is defined as VOC that results in a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug.

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Registration Coordinator

CONTACT

[email protected]

+1 610-878-4697

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 4, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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