RecruitingPhase 3NCT06100289

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

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

Sponsor

Takeda

Enrollment

70 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease Ulcerative Colitis

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing vedolizumab — a targeted biologic medication that reduces gut inflammation — in children and teenagers with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). It aims to determine whether this drug is safe and effective for younger patients who haven't responded well to other treatments. **You may be eligible if...** - Your child weighs at least 10 kg - Your child has been diagnosed with UC or Crohn's disease for at least 1 month - Your child's disease is moderate to severe (based on endoscopy and symptom scores) - Your child has previously tried and failed, lost response to, or couldn't tolerate at least one of the following: steroids, immunomodulators (like azathioprine or methotrexate), or a TNF-blocker (like infliximab or adalimumab) **You may NOT be eligible if...** - Your child has never tried any standard therapy - Your child has active serious infections (such as TB or certain viral illnesses) - Your child has had a known allergic reaction to vedolizumab or its components - Your child has certain complications such as bowel perforation, abscesses, or severe surgery-related complications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVedolizumab IV

Vedolizumab IV injection.

DRUGVedolizumab SC

Vedolizumab SC injection.

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)

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NCT06100289

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