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

NCT07224360 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-05-12

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2028-06-29
Completion
2028-06-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224360 on ClinicalTrials.gov