Recruiting
Phase 2

CSL889

Sponsor:

CSL Behring

Code:

NCT06699849

Conditions

Sickle Cell Disease Vaso-occlusive Crisis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

CSL889

Placebo

Study Details

Brief 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

Study ID

NCT06699849

Start date

Aug 7, 2025

Status verified date

Aug, 2026

Completion date

Oct 22, 2027

Anticipated

Primary completion date

Oct 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CSL889 Regimen 1

Participants in this arm will receive CSL889 as per regimen 1.

experimental: CSL889 Regimen 2

Participants in this arm will receive CSL889 as per regimen 2.

placebo comparator: Placebo

Participants in this arm will receive placebo matching to CSL889 regimen.

Interventions

CSL889

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

Placebo

Volume and regimen matched to CSL889 will be administered.

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Day 28 (End of study [EOS] Visit) ]
  • Percentage of participants with TEAEs [ Time Frame: Up to Day 28 (EOS Visit) ]
  • Number of participants with detectable treatment emergent (TE) anti-CSL889 antibodies [ Time Frame: Up to Day 28 (EOS Visit) ]
  • Percentage of participants with detectable TE anti-CSL889 antibodies [ Time Frame: Up to Day 28 (EOS Visit) ]
  • Time to resolution of VOC (time to discontinuation of parenteral opioids) [ Time Frame: Up to Day 28 (EOS Visit) ]

Central Contacts and Locations

Central contacts

Trial Registration Coordinator

+1 610-878-4697clinicaltrials@cslbehring.com

Locations

Univ. of California, San Francisco Health Care

Recruiting

Oakland, California, United States, 94609

Golisano Children's Hospital

Recruiting

Fort Myers, Florida, United States, 33908

The Foundation for Sickle Cell Disease

Recruiting

Hollywood, Florida, United States, 33023-6703

Arthur M. Blank Hospital-Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Detroit Medical Center

Recruiting

Detroit, Michigan, United States, 48201

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Jacobi Medical Center

Recruiting

The Bronx, New York, United States, 10461

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43085

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

CSL Behring

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Sickle cell disease
  • Acute kidney injury
  • Pharmacokinetics
  • Acute chest syndrome
  • Vaso-occlusive crisis
  • Hemopexin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CSL Behring on 2026-08-14.