A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD). (CROSSWALK-a)

  • STATUS
    Recruiting
  • End date
    Sep 14, 2023
  • participants needed
    30
  • sponsor
    Hoffmann-La Roche
Updated on 25 May 2022
opioid
thalassemia

Summary

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.

Details
Condition Sickle Cell Disease
Treatment Placebo, Crovalimab
Clinical Study IdentifierNCT04912869
SponsorHoffmann-La Roche
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Body weight >=40 kg
Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia)
Vaccination against Neisseria meningitidis
Vaccinations against H. influenzae type B and S. pneumoniae
Participants vaccinated against SARS-CoV-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine
Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics
Adequate hepatic and renal function
Hemoglobin >=5 g/dL
Participants receiving sickle cell therapies must be on a stable dose for >=28 days
Platelet count >=100,000/µL
For female participants of childbearing potential, an agreement to remain abstinent or use contraception for 6 months after the dose of study treatment

Exclusion Criteria

More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit
Pain related to the current VOE ongoing for >48 hours
Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism
Pain atypical of an acute uncomplicated VOE
Evidence of or suspicion of ACS
Evidence or high suspicion of a severe systemic infection
Major surgery and/or hospitalization for any reason within 30 days
History of Neisseria meningitidis infection within 6 months prior
Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol
Known HIV infection with a documented CD4 count <200 cells/µL
Immunized with a live attenuated vaccine within 30 days
History of hematopoietic stem cell transplant
Known or suspected hereditary complement deficiency
Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the study drug administration
Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater
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