Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease
2 other identifiers
interventional
63
5 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2026
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2025
CompletedFirst Posted
Study publicly available on registry
November 4, 2025
CompletedStudy Start
First participant enrolled
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 29, 2028
August 5, 2026
July 1, 2026
2.4 years
October 31, 2025
August 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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)
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.
From baseline up to Week 75
Percentage of participants with AESI
The following AEs are to be reported as AESI: neutropenia (CTCAE Grade 3 or 4), severe infection and neutropenic fever.
From baseline up to Week 75
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
Secondary Outcomes (2)
Serum concentration of Anumigilimab
From the first dose of anumigilimab to Week 65
Annualized rate of Vaso-occlusive crisis (VOC) (medical facility)
During the maintenance period from Week 13 to Week 65
Study Arms (2)
Anumigilimab
EXPERIMENTALSafety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD)
Placebo
PLACEBO COMPARATORParticipants will receive matching volume of placebo.
Interventions
Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.
Eligibility Criteria
You may qualify if:
- 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.
- b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (16)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2025
First Posted
November 4, 2025
Study Start
February 2, 2026
Primary Completion (Estimated)
June 29, 2028
Study Completion (Estimated)
June 29, 2028
Last Updated
August 5, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available.
- Access Criteria
- Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.