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Sickle Cell Disease Vaso-occlusive CrisisPhase 2NCT06699849

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

A Phase 2 study testing CSL889 in people with Sickle Cell Disease Vaso-occlusive Crisis, run by CSL Behring at 30 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
CSL889
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
30 sitesin 3 countries
Study dates
10 Jul 2025to 22 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Trial Registration Coordinator contact

+1 610-878-4697

clinicaltrials@cslbehring.com

30 sites in 3 countries

United States20 sites, 19 recruiting

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

    Atlanta, Georgia, 30329

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    USE CENTRAL Contact

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Use Central Contact

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43085

    USE CENTRAL CONTACT

    Recruiting

  • Detroit Medical Center

    Detroit, Michigan, 48201

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Use Central Contact

    Recruiting

  • Golisano Children's Hospital

    Fort Myers, Florida, 33908

    Use Central Contact

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Recruiting

  • The Foundation for Sickle Cell Disease

    Hollywood, Florida, 33023-6703

    Use Central Contact

    Recruiting

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

    Recruiting

  • Mount Sinai Medical Center

    New York, New York, 10029

    USE CENTRAL CONTACT

    Recruiting

  • Univ. of California, San Francisco Health Care

    Oakland, California, 94609

    Recruiting

  • University of California Irvine

    Orange, California, 92868

    Use Central Contact

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Withdrawn

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

    Recruiting

  • Jacobi Medical Center

    The Bronx, New York, 10461

    Central Contact

    Recruiting

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Recruiting

Other trials in United States

Turkey (Türkiye)7 sites, 7 recruiting

  • Baskent University School of Medicine

    Adana, 01120

    Recruiting

  • Hacettepe Universitesi

    Ankara, 06230

    Central Contact

    Recruiting

  • Istanbul Universitesi

    Istanbul, 34093

    Central Contact

    Not yet recruiting

  • Medical Park Mersin Hospital

    Mezitli-Mersin, 33200

    Recruiting

  • Özel Acibadem Adana Hastanesi

    Seyhan, 01130

    Central Contact

    Recruiting

  • Özel Acibadem Adana Hastanesi

    Seyhan/Adana, 01130

    Recruiting

  • Mersin Universitesi

    Yenişehir, 33110

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom3 sites, 3 recruiting

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

    Recruiting

  • University College London Hospitals NHS Trust

    London, NW1 2PG

    Recruiting

  • Guy's Hospital

    London, SE1 9RT

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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

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.

Being tested
CSL889, Placebo
Keywords
Sickle cell disease, Acute kidney injury, Pharmacokinetics, Acute chest syndrome, Vaso-occlusive crisis, Hemopexin
Medical subject headings
Anemia, Sickle Cell, Acute Kidney Injury, Acute Chest Syndrome, Vaso-Occlusive Crises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSL889Biological

    Also called Hemopexin, human

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

  • PlaceboDrug

    Volume and regimen matched to CSL889 will be administered.

Study groups in NCT06699849
Study groupRoleWhat they receive
CSL889 Regimen 1ExperimentalParticipants in this arm will receive CSL889 as per regimen 1.
Receives: Biological: CSL889
CSL889 Regimen 2ExperimentalParticipants in this arm will receive CSL889 as per regimen 2.
Receives: Biological: CSL889
PlaceboPlacebo comparatorParticipants in this arm will receive placebo matching to CSL889 regimen.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Measured: Up to Day 28 (End of study [EOS] Visit)

  2. Percentage of participants with TEAEs

    Measured: Up to Day 28 (EOS Visit)

  3. Number of participants with detectable treatment emergent (TE) anti-CSL889 antibodies

    Measured: Up to Day 28 (EOS Visit)

  4. Percentage of participants with detectable TE anti-CSL889 antibodies

    Measured: Up to Day 28 (EOS Visit)

  5. Time to resolution of VOC (time to discontinuation of parenteral opioids)

    Measured: Up to Day 28 (EOS Visit)

Secondary outcomes (21)

  1. Hospital admission rate

    Hospital admission rate in participants with SCD presenting with VOC who received greater than or equal to (≥) 1 dose of CSL889 in the acute care setting.

    Measured: Up to Day 28 (EOS Visit)

  2. Length of hospital stay (If hospitalized)

    Measured: Up to Day 28 (EOS Visit)

  3. Percentage of participants experiencing acute chest syndrome (ACS), acute kidney injury (AKI), or stroke

    Measured: From the start of investigational product (IP) administration up to Day 8

  4. Length of acute care stay

    Measured: Up to Day 28 (EOS Visit)

  5. Total Length of acute care and hospital stay

    Measured: Up to Day 28 (EOS Visit)

  6. Re-presentation rate to an acute care facility for VOC or ACS after discharge

    Measured: From discharge up to Day 28

  7. Hospital admission rate for VOC or ACS after discharge

    Measured: From discharge up to Day 28

  8. Opioid consumption

    Opioid consumption will be measured in morphine milligram equivalent units.

    Measured: From the time of enrollment to discharge (up to Day 28 [EOS Visit])

  9. Number of participants with ≥ 30% pain reduction by Numeric Rating Scale (NRS) score

    The NRS for pain is a validated self-reported 11-point pain severity scale (where 0 means no pain and 10 means the most or worst possible pain) that can be used in adults, adolescents, and children ≥ 8 years of age with SCD.

    Measured: Within 4 hours after the start of CSL889 infusion

  10. Percentage of participants with ≥ 30% pain reduction by NRS score

    The NRS for pain is a validated self-reported 11-point pain severity scale (where 0 means no pain and 10 means the most or worst possible pain) that can be used in adults, adolescents, and children ≥ 8 years of age with SCD.

    Measured: Within 4 hours after the start of CSL889 infusion

  11. Maximum observed concentration (Cmax) after Doses 1 and 3 of CSL889

    Measured: Before dosing, and up to 12 hours after Doses 1 and 3

  12. Area under the concentration (AUCtau) after Doses 1 and 3 of CSL889

    Measured: Before dosing, and up to 12 hours after Doses 1 and 3

  13. Time of maximum concentration (Tmax) after Doses 1 and 3 of CSL889

    Measured: Before dosing, and up to 12 hours after Doses 1 and 3

  14. Trough concentration (Ctrough) after each dose of CSL889

    Measured: Up to Day 5

  15. Accumulation ratio (AR) for AUCtau of CSL889 (the ratio between the AUCtau of Doses 3 and 1)

    Measured: Before dosing and at up to 12 hours after Doses 1 and 3

  16. AR for Cmax of CSL889 (the ratio between the Cmax of Doses 3 and 1)

    Measured: Before dosing and at up to 12 hours after Doses 1 and 3

  17. AR for Ctrough of CSL889 (the ratio between the Ctrough of the last dose and Dose 1)

    Measured: Before dosing and after Dose 1 and the last dose

  18. Cmax after each dose in Sparse PK subset of CSL889

    Sparse PK blood sampling will be performed in remainder of participants who are not in the Adult or Adolescent PK Subsets.

    Measured: Up to Day 5

  19. Ctrough after each dose in Sparse PK subset of CSL889

    Sparse PK blood sampling will be performed in remainder of participants who are not in the Adult or Adolescent PK Subsets.

    Measured: Up to Day 5

  20. AR for Cmax in Sparse PK subset of CSL889

    Sparse PK blood sampling will be performed in remainder of participants who are not in the Adult or Adolescent PK Subsets.

    Measured: Up to Day 5

  21. AR for Ctrough in Sparse PK subset of CSL889

    Sparse PK blood sampling will be performed in remainder of participants who are not in the Adult or Adolescent PK Subsets.

    Measured: Up to Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2024
  2. Study start10 Jul 2025
  3. Primary completion22 Oct 2027 (estimated)
  4. Study completion22 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06699849
Sponsor's protocol ID
CSL889_2001
Other IDs
2024-513440-29-00
Status last verified
Sep 2026
First submitted
19 Nov 2024
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CSL889 in people with Sickle Cell Disease Vaso-occlusive Crisis, run by CSL Behring at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Turkey (Türkiye), United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Registration Coordinator (+1 610-878-4697, clinicaltrials@cslbehring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to Day 28 (End of study [EOS] Visit)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06699849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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