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

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-000939-33-LT
• Lead Sponsor: Takeda Development Centre Europe, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-12
• Study Completion: 2019-01-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 771

Inclusion Criteria

1.Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
2.Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
3.Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
4.a.Has had previous treatment with tumor necrosis factor–alpha (TNF-
a) antagonists without documented clinical response to treatment (eg,
due to lack of response [primary nonresponders], loss of response, or
intolerance [secondary nonresponder], or
b.Has previously used a TNF-a antagonist (except adalimumab), and
discontinued its use due to reasons other than safety
5. Is naïve to TNF-a antagonist therapy but is failing current treatment
(ie, corticosteroids, 5-aminosalicylate, or immunomodulators)..
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 735
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

1.The subject has had an extensive colonic resection, subtotal or total
colectomy.
2.The subject has any evidence of an active infection during Screening.
3.The subject has a positive progressive multifocal leukoencephalopathy
(PML) subjective symptom checklist at Screening or before the
administration of study drug at Day 1.
4. The subject has received any investigational or approved biologic or
biosimilar agent (other than those listed below) within 60 days or 5 half
lives prior to screening (whichever is longer).
5. The subject has had prior exposure to vedolizumab, natalizumab,
efalizumab, adalimumab, etrolizumab, AMG-181, anti–mucosal addressin
cell adhesion molecule-1 (MAdCAM-1)-antibodies, 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 on clinical remission at Week 52.;<br> Secondary Objective: • To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.<br> • To evaluate the effect of vedolizumab IV compared to adalimumab SC on corticosteroid-free remission at Week 52.<br> ;Primary end point(s): Proportion of subjects achieving clinical remission (defined as a complete Mayo score of =2 points and no individual subscore >1 point) at Week 52.;Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome Measures

Name	Time	Method
<br> 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