A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

CompletadoFase 3ClinicalTrials.gov

ID: NCT03518086Tipo: INTERVENTIONALInicio: 18 de jun de 2018Fin estimado: 15 de may de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Diagnosis of UC for at least 3 months prior to baseline.
Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
If female, must meet the contraception requirements.

Criterios de exclusión

Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
Participants with a previous colectomy.
Participants with current evidence of toxic megacolon.
Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Intervenciones

drug

Mirikizumab

Administered IV

drug

Placebo

Administered IV

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

CABA, Buenos Aires, Argentina

Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina

CER Instituto Medico

Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

Fundación de Estudios Clínicos

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

C.I.C.E. 9 de Julio

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Privado Centro Medico de Cordoba SA

Córdoba, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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