Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

CompletadoFase 3ClinicalTrials.gov

ID: NCT02100696Tipo: INTERVENTIONALInicio: 21 de may de 2014Fin estimado: 16 de abr de 2020

Traducción no disponible, mostrando original

Resumen

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Diagnosis of UC established at least 3 months prior to Day 1
Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
Use of highly effective contraception as defined by the protocol
Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Criterios de exclusión

A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
Prior or planned surgery for UC
Past or present ileostomy or colostomy
Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
Any prior treatment with rituximab
Any treatment with tofacitinib during screening
Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
History of recurrent opportunistic infections and/or severe disseminated viral infections
History of organ transplant
Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
Received a live attenuated vaccine within 4 weeks prior to Day 1

Intervenciones

drug

Etrozulimab

Participants will receive 105 mg etrolizumab administered by SC injection Q4W.

drug

Placebo

Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.

Ubicaciones

Hospital Provincial del Centenario

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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