A Randomized DoubleBlind 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) - Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Takeda Development Centre Europe, Ltd.0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月23日

适应症

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 had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-a antagonist for their underlying CD (does not require treatment failure for currently active draining fistula); for subjects from France only: 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.

•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 of randomization.
•Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or antimucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
•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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