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An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Shikamura Mitsuhiro

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

smb.Japanclinicalstudydisclosure@takeda.com

Contact for Clinical Trial Information

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

+81-6-6204-2111

smb.Japanclinicalstudydisclosure@takeda.com

Recruiting

Jan. 22, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

1. The participant weighs >=10 kg at the time of screening and enrollment into the study.
2. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:
- Participants with UC: 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). (The results of screening endoscopy should be applied.)
- Participants with CD: a pediatric Crohn's disease activity index (PCDAI) >30 and a simple endoscopic score for Crohn's disease (SES-CD) >6 (or an SES-CD >=4 if disease is confined to terminal ileum) at screening endoscopy.
3. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor (TNF)-alfa antagonist therapy (for example, infliximab, adalimumab).
4. Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
5. Participants 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.
6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

1. Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab.
2. Participants who have had prior exposure to vedolizumab.
3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
5. The participant has received any live vaccinations within 30 days before first dose of study drug.
6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
7. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections.
8. Participants with a current diagnosis of indeterminate colitis.
9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
10. Participants with active or latent tuberculosis (TB).
11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (that is, HBsAg negative and hepatitis B surface antibody [anti-HBs]-positive) may, however, be included.
12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

Both

Ulcerative Colitis, Crohn's Disease

Induction Period: Participants >=30 kg, Vedolizumab (High Dose) IV
Participants weighing >=30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.

Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV
Participants weighing >15 to <30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.

Induction Period: Participants >=10 to <=15 kg, Vedolizumab (Low Dose) IV
Participants weighing >=10 to <=15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.

Maintenance Period: Participants >=30 kg, Vedolizumab 108 mg SC Q2W
Participants with clinical response at Week 14 weighing >=30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period.

Maintenance Period: Participants >=10 to <30 kg, Vedolizumab 108 mg SC Q4W
Participants with clinical response at Week 14 weighing >=10 to <30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period.

1. Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34
Time Frame: Predose at Week 34

2. Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34
Time Frame: Multiple time points prior to Week 34; pre-dose at Week 34

1. Percentage of Participants with Positive Antivedolizumab Antibody (AVA)
Time Frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)

2. Percentage of Participants with Positive Neutralizing AVA
Time Frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)

+81-942-31-7200

Sept. 24, 2024

Yes

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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