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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
CSL Behring
Study ID
NCT07224360
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
May 2026
Primary completion
Jun 29, 2028
Completion
Jun 29, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anumigilimab
    Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD)
  • Placebo Comparator: Placebo
    Participants will receive matching volume of placebo.

Primary Outcome Measure

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UAMS Medical CenterLittle RockArkansas72202-
The Foundation for Sickle Cell DiseaseHollywoodFlorida33023-6703-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Southern Specialty ResearchFlowoodMississippi39232-
Jacobi Medical CenterThe BronxNew York10461-

Find similar trials in Little Rock, AR

By condition
Sickle cell disease
By research site
UAMS Medical Center· Little Rock, ARThe Foundation for Sickle Cell Disease· Hollywood, FLCenter for Cancer and Blood Disorders· Bethesda, MDSouthern Specialty Research· Flowood, MSJacobi Medical Center· The Bronx, NY

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