A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE

Takeda Development Centre Europe, Ltd.0 个研究点目标入组 126 人开始时间: 2019年3月15日最近更新: 2019年4月30日

试验速览

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•-Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration.
•-Subjects who have historically failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD.
•-Noncutting seton placement as part of standard of care within 1 to 4 weeks prior to randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 107
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 19

•-Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
•-Subjects who have a CDAI score greater than 400.
•-Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
•-Subjects who have significant anal or rectal stenosis.
•-Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during screening, other than related to the fistula(e).
•-Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist.
•-Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer).
•-Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.
•- Subjects who have active or latent tuberculosis.
•- Subjects who have a known history of hepatitis B virus (HBV), hepatitis C virus (HCV), acquired human immunodeficiency virus (HIV), or are found to be seropositive at Screening.

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