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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease Vaso-occlusive Crisis

In brief

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.

Key facts

Study ID

NCT06699849

Run by

CSL Behring

People needed

70

Starts

2025-08-07

Expected to finish

2027-10-22

Last updated by the study team

2026-05-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ. of California, San Francisco Health Care — Oakland, California, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• Golisano Children's Hospital — Fort Myers, Florida, United States (enrolling)
• The Foundation for Sickle Cell Disease — Hollywood, Florida, United States (enrolling)
• University of Louisville Hospital — Louisville, Kentucky, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Detroit Medical Center — Detroit, Michigan, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Mount Sinai Medical Center — New York, New York, United States (enrolling)
• Jacobi Medical Center — The Bronx, New York, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• University of California Irvine — Orange, California, United States
• Istanbul Universitesi — Istanbul, Turkey (Türkiye)
• Özel Acibadem Adana Hastanesi — Seyhan, Turkey (Türkiye)
• Hacettepe Universitesi — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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