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NCT06100289PHASE3Recruiting

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

Takeda

Start Date

1/22/2025

Completion Date

11/15/2027

Summary

The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times.

Detailed Description

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat pediatric participants with moderate to severe active UC or CD who achieved clinical response following open-label vedolizumab intravenous (IV) therapy. The study will look at the pharmacokinetics, safety, and immunogenicity of vedolizumab. The study will enroll approximately 70 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as: * Participants ≥30 kilograms (kg), Vedolizumab (High Dose) * Participants \>15 to \<30 kg, Vedolizumab (Medium Dose) * Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) At Week 14, participants who achieve clinical response will be assigned to one of the following groups, stratified by weight to receive vedolizumab 108 mg SC injection during the 20-week Maintenance Period: * Participants ≥30 kg, Vedolizumab 108 mg once every 2 weeks (Q2W) * Participants ≥10 to \<30 kg, Vedolizumab 108 mg once every 4 weeks (Q4W) This multi-center trial will be conducted globally. After the Week 34 end of treatment (EOT) visit assessments have been completed, participants may be eligible to receive continued treatment with vedolizumab SC in an extension study, whereas participants who do not qualify to receive continued treatment in the extension study or participants who discontinue from the study for any reason will complete the EOT visit, and the follow-up safety visit (18 weeks after last dose).

Eligibility Criteria

Age Range: 2 years to 17 years

Inclusion Criteria: 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)-α 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. Exclusion Criteria: 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.

Interventions

DRUG

Vedolizumab IV

DRUG

Vedolizumab SC

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Conditions

Ulcerative ColitisCrohn's Disease

Locations

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Loma Linda University School of Medicine

Loma Linda, California 92354

United States

Children's Hospital Of Orange County

Orange, California 92868

United States

Stanford Children's Health

Palo Alto, California 94304

United States

Advocate Children's Hospital

Park Ridge, Illinois 60068

United States

Children's Hospital of Michigan

Detroit, Michigan 48201

United States

Atlantic Health System

Morristown, New Jersey 07960

United States

New York Presbyterian Hospital, Weill Cornell Medical College

New York, New York 10065

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine

Hershey, Pennsylvania 17033

United States

Medical University of South Carolina

North Charleston, South Carolina 29406

United States

MultiCare Institute for Research & Innovation

Tacoma, Washington 98405

United States

Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Centre Hospitalier Chretien MontLegia

Liège, 4000

Belgium

University Hospital "Saint George"

Plovdiv, 4002

Bulgaria

Hvidovre University Hospital

Hvidovre, Capital Region 2650

Denmark

Childrens Health Ireland

Dublin, D12 N512

Ireland

Azienda Ospedaliera Universitaria Gaetano Martino Messina

Messina, 98124

Italy

V. Buzzi Hospital

Milan, 20154

Italy

Unita Operativa Complessa Di Pediatria Medica

Pescara, 65125

Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Rome, 00165

Italy

Kurume University Hospital

Kurume, Fukuoka 830-0011

Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo 113-8431

Japan

National Center for Child Health and Development (NCCHD)

Setagaya-Ku, Tokyo 157-8535

Japan

Radboud University Medical Center

Nijmegen, 6525 GA

Netherlands

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship 04730

Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, 35302

Poland

Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501

Poland

SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach

Zabrze, 41-800

Poland

Hospital Pediatrico - Unidade Local de Saude de Coimbra

Coimbra, 3000-602

Portugal

Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE

Lisbon, 1649-035

Portugal

Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio

Porto, 4050-165

Portugal

"Emergency County Clinical Hospital ""Pius Brinzeu"""

Timișoara, Timiș County 300226

Romania

Dr Victor Gomoiu Clinical Children Hospital

Bucharest, 022102

Romania

Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,

Bucharest, 11743

Romania

University Children's Hospital

Belgrade, 11000

Serbia

Mother and child helath care Institute of Serbia dr Vukan Cupic

Belgrade, 11070

Serbia

Institute for Childand YouthHealth Care of Vojvodina

Novi Sad, 21000

Serbia

Kyungpook National University Chilgok Hospital (KNUCH)

Daegu, 41404

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Complejo Hospitalario Universitario de Ferrol

Ferrol, 15405

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital U. Virgen Macarena

Seville, 41009

Spain

Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. Spain

Valencia, 46026

Spain

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud 1011

Switzerland

Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus

Bern, 3010

Switzerland

Universitats-Kinderspital

Zurich, 8008

Switzerland

National Taiwan University Children's Hospital

Taipei, Zhongzheng Dist 100

Taiwan

Changhua Christian Hospital

Changhua, 500010

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756

Taiwan