A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease
Activo, no reclutaFase 3ClinicalTrials.gov
ID: NCT04232553Tipo: INTERVENTIONALInicio: 22 de jun de 2020Fin estimado: 1 de abr de 2027
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
Elegibilidad
Edad mínima: 18 YearsSexo: ALL
Criterios de inclusión
If female, participant must meet the contraception requirements
Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
Criterios de exclusión
Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.
Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.
Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
Intervenciones
drug
Mirikizumab
Administered Q4W
Ubicaciones
DOM Centro de Reumatología
Buenos Aires, Argentina
Patrocinadores
PrincipalEli Lilly and Company
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