A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

CompletadoFase 3ClinicalTrials.gov

ID: NCT03926130Tipo: INTERVENTIONALInicio: 23 de jul de 2019Fin estimado: 2 de oct de 2023

Traducción no disponible, mostrando original

Resumen

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Elegibilidad

Edad mínima: 15 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Diagnosis of CD for at least 3 months prior to baseline
Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
If female, subject must meet the contraception recommendations

Criterios de exclusión

Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
Have a stoma, ileoanal pouch or ostomy
Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
Have ever received any monoclonal antibodies binding IL-23

Intervenciones

drug

Mirikizumab

Administered IV

drug

Mirikizumab

Administered SC

drug

Ustekinumab

Administered IV

drug

Ustekinumab

Administered SC

drug

Placebo

Administered IV

drug

Placebo

Administered SC

Ubicaciones

DOM- Centro de Reumatologia

CABA, Buenos Aires, Argentina

Mautalen Salud e Investigación

CABA, Buenos Aires, Argentina

CEMIC- Servicio de Reumatología

CABA, Buenos Aires, Argentina

Instituto Medico Elsa Perez SRL (IMEP)

Ciudadela, Buenos Aires, Argentina

CIPREC

Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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