Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitiscompared to Adalimumab SC

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-000939-33-IT
• Lead Sponsor: TAKEDA DEVELOPMENT CENTRE EUROPE LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-18
• Study Start: 2021-06-08
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 771

Inclusion Criteria

The subject has a diagnosis of UC established at least 6 months prior to enrollment, by clinical and endoscopic evidence and corroborated by a histopathology report.
The subject has moderately to severely active UC as determined by a complete Mayo score of 6-12 with an endoscopic subscore =2 within 14 days prior to randomization.
The subject has evidence of UC extending proximal to the rectum (=15 cm of involved colon).
The subject has had previous treatment with tumor necrosis factor–alpha (TNF-a) antagonists without documented clinical response to treatment or the subject is naïve to TNF-a antagonist therapy but is failing current conventional treatment.

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 638
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

The subject has had extensive colonic resection, subtotal or total colectomy.
The subject has any evidence of an active infection during Screening.
The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective checklist before the administration of study drug.
The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to screening (whichever is longer).
The subject has had prior exposure to vedolizumab, natalizumab, efalizumab, adalimumab or rituximab.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of vedolizumab IV compared to adalimumab SC<br>on clinical remission at Week 52.;Secondary Objective: ¿ To evaluate the effect of vedolizumab IV compared to adalimumab SC<br>on mucosal healing at Week 52.<br>¿ To evaluate the effect of vedolizumab IV compared to adalimumab SC<br>on corticosteroid-free remission at Week 52.;Primary end point(s): Proportion of subjects achieving clinical remission (defined as a<br>complete Mayo score of =2 points and no individual subscore >1 point)<br>at Week 52.;Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ¿Proportion of subjects achieving mucosal healing (defined as Mayo endoscopic subscore =1 point) at Week 52.<br>¿Proportion of subjects using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at Week 52.<br>;Timepoint(s) of evaluation of this end point: Week 52