NCT06699849

Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

A Phase 2, Multicenter, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, randomized, multiple-dose, placebo-controlled study designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to evaluate the safety and tolerability of CSL889 in study participants, and to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD.

Conditions

• Sickle Cell Disease Vaso-occlusive Crisis

Interventions

Type	Name	Description
BIOLOGICAL	CSL889	CSL889 is a solution for infusion to be administered by the IV route.
DRUG	Placebo	Volume and regimen matched to CSL889 will be administered.

Timeline

• Start date: 2025-07-10
• Primary completion: 2027-10-22
• Completion: 2027-10-22
• First posted: 2024-11-21
• Last updated: 2026-04-16

Locations

17 sites across 2 countries: United States, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study