Status:
COMPLETED
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).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
12-55 years
Phase:
PHASE1
Brief 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. Th...
Eligibility Criteria
Inclusion
- 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 serotypes A, C, W, and Y.
- 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 grams/deciliter (g/dL)
- Platelet count \>=100,000/microliter (µL)
- Participants receiving SCD-directed therapies must be on a stable dose for \>=28 days.
- For female participants of childbearing potential, an agreement to remain abstinent or use contraception for 322 days (approximately 10.5 months) after the dose of study treatment.
Exclusion
- 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 \>36 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.
- Known HIV infection with a documented CD4 count \<200 cells/µL.
- Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol.
- 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 322 days (approximately 10.5 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.
Key Trial Info
Start Date :
March 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04912869
Start Date
March 26 2022
End Date
August 15 2025
Last Update
August 26 2025
Active Locations (16)
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1
Children'S Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
3
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil, 41253-190
4
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil