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Sperimentazione clinica volta a valutare la sicurezza e l’efficacia di crovalimab nella riduzione delle crisi dolorose, chiamate anche episodi vaso-occlusivi (VOE), in soggetti con anemia falciforme (SCD)
A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
- Disturbi ematologici
- Anemia falciforme
Lo stato dell'arruolamento dello studio presso il proprio centro locale potrebbe differire da quello complessivo dello studio, in quanto alcuni centri dello studio potrebbero arruolare i pazienti prima di altri.
Stato dello studio:
Attiva, non in fase di reclutamento
Questo studio si svolge in
Città
- Adana
- Amsterdam
- Botucatu
- Detroit
- Distretto di Tripoli
- Eldoret
- Greenville
- Johannesburg
- London
- Madison
- Madrid
- Nairobi
- Napoli
- New York
- Porto Alegre
- Ribeirao Preto
- Rio de Janeiro
- Salvador
- Sevilla
- São José do Rio Preto
- São Paulo
- Verona
- Zaragoza
Codice identificativo dello studio:
NCT05075824 2020-004839-25 BO42451
Riassunto dello studio
This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.
Hoffmann-La Roche
Sponsor
Fase 2
Fase
NCT05075824, BO42451, 2020-004839-25
Codice identificativo dello studio
Crovalimab, Placebo
Trattamenti
Sickle Cell Disease
Condizione
Titolo ufficiale
A randomized, double-blind, phase IIa study evaluating efficacy, safety, pharmacokinetics and pharmacodynamics of crovalimab as adjunct treatment in prevention of vaso-occlusive episodes (VOE) in sickle cell disease (SCD)
Criteri di idoneità
Tutti
Sesso
≥12 Anni & ≤ 55 Anni
Età
No
Volontari sani
Criteri di inclusione
- Body weight >=40 kg.
- Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
- Two or more (>=2) to <=10 documented VOEs in the 12 months prior to randomisation.
- If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons.
- If receiving erythropoietin, the participant must have been prescribed this medication for the preceding 3 months and be dose-stabilised for at least 3 months prior to study enrollment.
- Vaccination against N. meningitides serotypes A, C, W, and Y and Vaccinations against H. influenza type B and S. pneumonia.
- Participants who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation.
- Adequate hepatic and renal function.
- For women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of study treatment.
Criteri di esclusione
- History of hematopoietic stem cell transplant.
- Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study.
- History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment.
- Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial.
- Hemoglobin <6 g/dL.
- Known or suspected hereditary complement deficiency.
- Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration.
- Presence of fever (>=38 degrees Celsius) within 7 days before the first drug administration.
- Immunised with a live attenuated vaccine within 1 month before first drug administration.
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 10.5 months after the final dose of study treatment.
- Known HIV infection with documented CD4 count <200 cells/microliter within 24 weeks prior to screening.
- History of N. meningitidis infection within the prior 6 months.
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