A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis - EARNEST

Takeda Development Centre Europe, Ltd.0 个研究点目标入组 110 人开始时间: 2016年6月27日最近更新: 2020年10月6日

试验速览

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•-Male or female subjects aged 18 to 80 years, inclusive.
•-History of IPAA for UC completed at least 1 year prior to the Day 1 (Randomization) Visit.
•-Pouchitis that is chronic or recurrent, defined by an mPDAI score =5 assessed as the average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) =3 recurrent episodes within 1 year prior to the Screening Period treated with =2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for =4 weeks immediately prior to the Baseline Endoscopy Visit.
•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 94
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•-Crohn’s disease (CD), CD of the pouch, irritable pouch syndrome (IPS), isolated or predominant cuffitis, diverting stoma, or mechanical complications of the pouch.
•-Previous treatment with vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
•-Any investigational or approved biologic or biosimilar agent within 60 days of randomization.
•-Nonbiologic investigational therapy within 30 days prior to randomization.
•-Active or latent tuberculosis.
•-Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection or a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at Screening) or subject is immunodeficient.
•-Active, severe infection.
•-Positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening.

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