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

Part of paid clinical trials in Oakland, California.

Sponsor
CSL Behring
Study ID
NCT06699849
Phase
PHASE2
Status
Recruiting
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Conditions

  • Sickle Cell Disease Vaso-occlusive Crisis

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Aug 7, 2025
Status verified
May 2026
Primary completion
Oct 22, 2027
Completion
Oct 22, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Day 28 (End of study [EOS] Visit) ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Univ. of California, San Francisco Health CareOaklandCalifornia94609-
University of California IrvineOrangeCalifornia92868
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Golisano Children's HospitalFort MyersFlorida33908
Use Central Contact
The Foundation for Sickle Cell DiseaseHollywoodFlorida33023-6703
Use Central Contact
University of Louisville HospitalLouisvilleKentucky40202-
University of MarylandBaltimoreMaryland21201
USE CENTRAL Contact
Detroit Medical CenterDetroitMichigan48201-
Henry Ford Health SystemDetroitMichigan48202
Use Central Contact
Mount Sinai Medical CenterNew YorkNew York10029
USE CENTRAL CONTACT
Jacobi Medical CenterThe BronxNew York10461
Central Contact
East Carolina UniversityGreenvilleNorth Carolina27834-
University of CincinnatiCincinnatiOhio45267
Use Central Contact
The Ohio State UniversityColumbusOhio43085
USE CENTRAL CONTACT
Hillman Cancer CenterPittsburghPennsylvania15232-
University of PittsburghPittsburghPennsylvania15224-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Oakland, CA

By research site
Univ. of California, San Francisco Health Care· Oakland, CAUniversity of California Irvine· Orange, CAGolisano Children's Hospital· Fort Myers, FLThe Foundation for Sickle Cell Disease· Hollywood, FLUniversity of Louisville Hospital· Louisville, KYUniversity of Maryland· Baltimore, MD