Back to Trials
NCT06699849PHASE2Recruiting

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

CSL Behring

Start Date

8/7/2025

Completion Date

10/22/2027

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 Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * At the time of informed consent: * 18 years of age (adults); or * 12 to less than (\<) 18 years of age (adolescents, where approved and when enrollment for adolescents has been opened by the sponsor, with the endorsement of the Independent Data Monitoring Committee \[IDMC\]) * Diagnosed with SCD (any genotype). * Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids. Exclusion Criteria: * VOC pain onset greater than (\>) 72 hours before administration of first parenteral opioid. * Must not have a history of \> 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological symptoms suggestive of acute stroke or transient ischemic attack; or any stage (acute kidney injury) AKI; or been discharged from inpatient hospital admission for VOC or other vaso-occlusive event within 14 days before the current presentation. * Serum hemoglobin \< 6 g/dL, serum ferritin ≥ 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine.

Interventions

BIOLOGICAL

CSL889

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Sickle Cell Disease Vaso-occlusive Crisis

Locations

Univ. of California, San Francisco Health Care

Oakland, California 94609

United States

University of California Irvine

Orange, California 92868

United States

Golisano Children's Hospital

Fort Myers, Florida 33908

United States

The Foundation for Sickle Cell Disease

Hollywood, Florida 33023-6703

United States

University of Louisville Hospital

Louisville, Kentucky 40202

United States

University of Maryland

Baltimore, Maryland 21201

United States

Detroit Medical Center

Detroit, Michigan 48201

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Mount Sinai Medical Center

New York, New York 10029

United States

Jacobi Medical Center

The Bronx, New York 10461

United States

East Carolina University

Greenville, North Carolina 27834

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

The Ohio State University

Columbus, Ohio 43085

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States

Hacettepe Universitesi

Ankara, 06230

Turkey (Türkiye)

Istanbul Universitesi

Istanbul, 34093

Turkey (Türkiye)

Özel Acibadem Adana Hastanesi

Seyhan, 01130

Turkey (Türkiye)