A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for … (NCT04912869) | Clinical Trial Compass
CompletedPhase 1
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).
United States, Brazil, France30 participantsStarted 2022-03-26
Plain-language 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.
Who can participate
Age range12 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 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 \>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…
What they're measuring
1
Percentage of Participants With Adverse Events (AEs)
Timeframe: Baseline up to Day 84
2
Percentage of Participants with Infusion-Related Reactions and Hypersensitivity