NCT07224360

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Sickle Cell Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-02
• Primary completion: 2028-06-29
• Completion: 2028-06-29
• First posted: 2025-11-04
• Last updated: 2026-02-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study