RecruitingPhase 2NCT06699849

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


Sponsor

CSL Behring

Enrollment

70 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CSL889 and a drug called Placebo for people with sickle cell disease vaso-occlusive crisis. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCSL889

CSL889 is a solution for infusion to be administered by the IV route.

DRUGPlacebo

Volume and regimen matched to CSL889 will be administered.


Locations(19)

Univ. of California, San Francisco Health Care

Oakland, California, United States

University of California Irvine

Orange, California, United States

Golisano Children's Hospital

Fort Myers, Florida, United States

The Foundation for Sickle Cell Disease

Hollywood, Florida, United States

University of Louisville Hospital

Louisville, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Detroit Medical Center

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Mount Sinai Medical Center

New York, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

East Carolina University

Greenville, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Hacettepe Universitesi

Ankara, Turkey (Türkiye)

Istanbul Universitesi

Istanbul, Turkey (Türkiye)

Özel Acibadem Adana Hastanesi

Seyhan, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT06699849