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RECRUITING

NCT06100289

PHASE3

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-01-22

Completion Date

2027-06-30

Last Updated

2025-09-19

Healthy Volunteers

Conditions

Ulcerative Colitis Crohn's Disease

Interventions

DRUG

Vedolizumab IV

Vedolizumab IV injection.

DRUG

Vedolizumab SC

Vedolizumab SC injection.

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.

Locations (57)

VVCRD Clinical Research

Garden Grove, California, United States

Loma Linda University School of Medicine

Loma Linda, California, United States

Children's Hospital Of Orange County

Orange, California, United States

Stanford Children's Health

Palo Alto, California, United States

Advocate Children's Hospital

Park Ridge, Illinois, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Atlantic Health System

Morristown, New Jersey, United States

New York Presbyterian Hospital, Weill Cornell Medical College

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Medical University of South Carolina

North Charleston, South Carolina, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Centre Hospitalier Chretien MontLegia

Liège, Belgium

University Hospital "Saint George"

Plovdiv, Bulgaria

Specialized Hospital for Active Treatment of Children Diseases "Prof. Dr. Ivan Mitev" EAD

Sofia, Bulgaria

Hvidovre University Hospital

Hvidovre, Capital Region, Denmark

H.C Andersens Hospital

Odense, Denmark

Childrens Health Ireland

Dublin, Ireland

Azienda Ospedaliera Universitaria Gaetano Martino Messina

Messina, Italy

V. Buzzi Hospital

Milan, Italy

Unita Operativa Complessa Di Pediatria Medica

Pescara, Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Rome, Italy

Kurume University Hospital

Kurume, Fukuoka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

National Center for Child Health and Development (NCCHD)

Setagaya-Ku, Tokyo, Japan

Radboud University Medical Center

Nijmegen, Netherlands

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Szpital Dzieciecy W Krakowie

Krakow, Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Poland

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

Warsaw, Poland

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

Zabrze, Poland

Hospital Pediatrico - Unidade Local de Saude de Coimbra

Coimbra, Portugal

Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE

Lisbon, Portugal

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

Porto, Portugal

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

Timișoara, Timiș County, Romania

Dr Victor Gomoiu Clinical Children Hospital

Bucharest, Romania

Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,

Bucharest, Romania

University Children's Hospital

Belgrade, Serbia

Mother and child helath care Institute of Serbia dr Vukan Cupic

Belgrade, Serbia

Institute for Childand YouthHealth Care of Vojvodina

Novi Sad, Serbia

Kyungpook National University Chilgok Hospital (KNUCH)

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Complejo Hospitalario Universitario de Ferrol

Ferrol, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital U. Virgen Macarena

Seville, Spain

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

Valencia, Spain

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

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

Bern, Switzerland

Universitats-Kinderspital

Zurich, Switzerland

National Taiwan University Children's Hospital

Taipei, Zhongzheng Dist, Taiwan

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Koc University Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

Istanbul University, Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)