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

NCT06100289 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: VedolizumabSC-30032023-503188-40-00jRCT2071240072
• Study Type: interventional
• Target: 70
• Locations: 17 countries
• Sites: 57

Brief 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.

Conditions

Ulcerative Colitis; Crohn's Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34

  Predose at Week 34

• Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34

  Multiple time points prior to Week 34; pre-dose at Week 34

Secondary Outcomes (2)

• Percentage of Participants with Positive Antivedolizumab Antibody (AVA)

  Baseline up to 18 weeks after last dose of study drug (up to Week 50)

• Percentage of Participants with Positive Neutralizing AVA

  Baseline up to 18 weeks after last dose of study drug (up to Week 50)

Study Arms (5)

Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV

EXPERIMENTAL

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

Drug: Vedolizumab IV

Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV

EXPERIMENTAL

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

Drug: Vedolizumab IV

Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV

EXPERIMENTAL

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

Drug: Vedolizumab IV

Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W

EXPERIMENTAL

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.

Drug: Vedolizumab SC

Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W

EXPERIMENTAL

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.

Drug: Vedolizumab SC

Interventions

Vedolizumab IV DRUG

Vedolizumab IV injection.

Also known as: ENTYVIO, KYNTELES, MLN0002

Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV; Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV; Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV

Vedolizumab SC DRUG

Vedolizumab SC injection.

Also known as: MLN0002SC

Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W; Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participant weighs ≥10 kg at the time of screening and enrollment into the study.
• 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.
• 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).
• Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
• 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.
• Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

You may not qualify if:

• 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.
• Participants who have had prior exposure to vedolizumab.
• Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
• Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
• The participant has received any live vaccinations within 30 days before first dose of study drug.
• Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
• 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.
• Participants with a current diagnosis of indeterminate colitis.
• Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
• Participants with active or latent tuberculosis (TB).
• 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.
• The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
• Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
• Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

Sponsors & Collaborators

• Takeda: lead

Study Sites (57)

VVCRD Clinical Research

Garden Grove, California, 92845-2006, United States

TERMINATED

Loma Linda University School of Medicine

Loma Linda, California, 92354, United States

ACTIVE NOT RECRUITING

Children's Hospital Of Orange County

Orange, California, 92868, United States

ACTIVE NOT RECRUITING

Stanford Children's Health

Palo Alto, California, 94304, United States

ACTIVE NOT RECRUITING

Advocate Children's Hospital

Park Ridge, Illinois, 60068, United States

ACTIVE NOT RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

Atlantic Health System

Morristown, New Jersey, 07960, United States

ACTIVE NOT RECRUITING

New York Presbyterian Hospital, Weill Cornell Medical College

New York, New York, 10065, United States

ACTIVE NOT RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

ACTIVE NOT RECRUITING

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

ACTIVE NOT RECRUITING

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

ACTIVE NOT RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Centre Hospitalier Chretien MontLegia

Liège, 4000, Belgium

ACTIVE NOT RECRUITING

University Hospital "Saint George"

Plovdiv, 4002, Bulgaria

ACTIVE NOT RECRUITING

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

Sofia, 1606, Bulgaria

ACTIVE NOT RECRUITING

Hvidovre University Hospital

Hvidovre, Capital Region, 2650, Denmark

ACTIVE NOT RECRUITING

H.C Andersens Hospital

Odense, 5000, Denmark

ACTIVE NOT RECRUITING

Childrens Health Ireland

Dublin, D12 N512, Ireland

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria Gaetano Martino Messina

Messina, 98124, Italy

ACTIVE NOT RECRUITING

V. Buzzi Hospital

Milan, 20154, Italy

ACTIVE NOT RECRUITING

Unita Operativa Complessa Di Pediatria Medica

Pescara, 65125, Italy

ACTIVE NOT RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesu

Rome, 00165, Italy

ACTIVE NOT RECRUITING

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

ACTIVE NOT RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

National Center for Child Health and Development (NCCHD)

Setagaya-Ku, Tokyo, 157-8535, Japan

ACTIVE NOT RECRUITING

Radboud University Medical Center

Nijmegen, 6525 GA, Netherlands

ACTIVE NOT RECRUITING

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship, 04730, Poland

RECRUITING

Uniwersytecki Szpital Dzieciecy W Krakowie

Krakow, 30-663, Poland

ACTIVE NOT RECRUITING

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, 35302, Poland

RECRUITING

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

Warsaw, 04-501, Poland

RECRUITING

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

Zabrze, 41-800, Poland

ACTIVE NOT RECRUITING

Hospital Pediatrico - Unidade Local de Saude de Coimbra

Coimbra, 3000-602, Portugal

ACTIVE NOT RECRUITING

Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE

Lisbon, 1649-035, Portugal

ACTIVE NOT RECRUITING

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

Porto, 4050-165, Portugal

ACTIVE NOT RECRUITING

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

Timișoara, Timiș County, 300226, Romania

ACTIVE NOT RECRUITING

Dr Victor Gomoiu Clinical Children Hospital

Bucharest, 022102, Romania

RECRUITING

Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,

Bucharest, 11743, Romania

RECRUITING

University Children's Hospital

Belgrade, 11000, Serbia

RECRUITING

Mother and child helath care Institute of Serbia dr Vukan Cupic

Belgrade, 11070, Serbia

ACTIVE NOT RECRUITING

Institute for Childand YouthHealth Care of Vojvodina

Novi Sad, 21000, Serbia

ACTIVE NOT RECRUITING

Kyungpook National University Chilgok Hospital (KNUCH)

Daegu, 41404, South Korea

ACTIVE NOT RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Complejo Hospitalario Universitario de Ferrol

Ferrol, 15405, Spain

ACTIVE NOT RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

ACTIVE NOT RECRUITING

Hospital U. Virgen Macarena

Seville, 41009, Spain

RECRUITING

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

Valencia, 46026, Spain

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

ACTIVE NOT RECRUITING

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

Bern, 3010, Switzerland

ACTIVE NOT RECRUITING

Universitats-Kinderspital

Zurich, 8008, Switzerland

RECRUITING

National Taiwan University Children's Hospital

Taipei, Zhongzheng Dist, 100, Taiwan

RECRUITING

Changhua Christian Hospital

Changhua, 500010, Taiwan

ACTIVE NOT RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

ACTIVE NOT RECRUITING

Koc University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

SUSPENDED

Istanbul University, Istanbul Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

SUSPENDED

Dokuz Eylul University Medical Faculty

Izmir, 35340, Turkey (Türkiye)

SUSPENDED

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: January 22, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

IE (1); ES (4); BU (2); PL (5); DK (2); TW (3); RO (3); IT (4); TU (3); PT (3); BE (2); JP (3); KR (4); CH (3); US (11); NL (1); SE (3)