A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis

Phase 1

• Conditions: Moderately to severely active Ulcerative Colitis (UC); MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-004300-34-PL
• Lead Sponsor: Takeda Development Center Americas, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. The subjects aged 2 to 17 years, inclusive, at the time of screening and enrollment into the maintenance phase of the study.
2. The subject weighs =10 kg at the time of screening and enrollment into the study.
3. Subjects with UC diagnosed at least 1 month before screening. Subjects with moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of =2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy.
4. Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine, 6-mercaptopurine, methotrexate), and/or TNF-a antagonist therapy (eg, infliximab, adalimumab). This includes subjects who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease when attempting to wean off corticosteroids.
5. Subjects with evidence of UC extending proximal to the rectum (ie, not limited to proctitis), at a minimum.
6. Subjects with extensive colitis or pancolitis of >8 years’ duration or left-sided colitis of >12 years’ duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
7. Subjects with vaccinations that are up to date based on the countrywide, accepted schedule of childhood vaccines.

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who have had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or AMG 181, or mucosal addressin cell adhesion molecule-1 antagonists or rituximab.
2. Subjects who have had prior exposure to vedolizumab.
3. Subjects with hypersensitivity or allergies to vedolizumab or any of its excipients.
4. Subjects who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
5. Subjects with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
6. Subjects who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
7. Subjects who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
8. Subjects with a current diagnosis of indeterminate colitis.
9. Subjects with clinical features suggesting monogenic very early onset inflammatory bowel disease.
10. The subject has other serious comorbidities that will limit his or her ability to complete the study

Study & Design

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