A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

CompletadoFase 3ClinicalTrials.gov

ID: NCT03524092Tipo: INTERVENTIONALInicio: 19 de oct de 2018Fin estimado: 17 de feb de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
If female, must meet the contraception requirements.

Criterios de exclusión

Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

Intervenciones

drug

Mirikizumab SC

Administered SC

drug

Mirikizumab IV

Administered IV

drug

Placebo SC

Administered SC

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

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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