RecruitingPhase 3NCT05442567

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease

Sponsor

Takeda

Enrollment

240 participants

Start Date

May 16, 2023

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease Ulcerative Colitis

Summary

The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study is following children with ulcerative colitis (UC) or Crohn's disease who previously responded well to the drug vedolizumab in an earlier study, to see how they do over a longer period. **You may be eligible if...** - Your child completed a prior vedolizumab study (MLN0002-3024 or MLN0002-3025) - Your child achieved a good response to vedolizumab and is off steroids at Week 54 of that prior study - Your child meets age and weight requirements for the study drug **You may NOT be eligible if...** - Your child did not complete or respond to the prior study - Your child has active, serious infections - Your child has certain immune or medical conditions that make the study drug unsafe 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVedolizumab IV

Vedolizumab IV infusion

OTHERNo Intervention

Participants will not receive any intervention in the Observational Cohort.

Locations(98)

University of South Alabama (USA) Physicians Group

Mobile, Alabama, United States

Phoenix Childrens Hospital - Thomas Rd - PIN

Phoenix, Arizona, United States

Cedars Sinai Medical Center - 127 San Vicente Blvd

Los Angeles, California, United States

Rady Children's Hospital - San Diego - PIN

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

I.H.S Health LLC-Kissimmee-445 W Oak St

Kissimmee, Florida, United States

Childrens Center For Digestive Healthcare

Atlanta, Georgia, United States

Advocate Children's Hospital - Park Ridge - PIN

Park Ridge, Illinois, United States

Riley Hospital For Children - PIN

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Children's Hospital - PIN

Boston, Massachusetts, United States

MNGI Digestive Health PA-Plymouth

Minneapolis, Minnesota, United States

Mayo Clinic - PIN

Rochester, Minnesota, United States

Goryeb Children's Hospital

Morristown, New Jersey, United States

Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN

New Hyde Park, New York, United States

University of Rochester Medical Center - PPDS

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

University Hospitals Cleveland Medical Center - 11100 Euclid Ave

Cleveland, Ohio, United States

UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN

Pittsburgh, Pennsylvania, United States

Hasbro Children's Hospital - PIN

Providence, Rhode Island, United States

Texas Children's Hospital - Baylor - PIN

Houston, Texas, United States

Carilion Children's Tanglewood Center

Roanoke, Virginia, United States

Children's Hospital at Westmead

Westmead, New South Wales, Australia

Queensland Childrens Hospital

South Brisbane, Queensland, Australia

Monash Health, Monash Medical Centre

Clayton, Victoria, Australia

Royal Children's Hospital Melbourne - PIN

Parkville, Victoria, Australia

UZ Antwerpen - PIN

Edegem, Antwerpen, Belgium

UZ Brussel - PIN

Jette, Brussels Capital, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

University of Alberta Hospital

Edmonton, Alberta, Canada

British Columbia Children's Hospital - 4480 Oak St

Vancouver, British Columbia, Canada

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, Beijing Municipality, China

Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus

Zhengzhou, Henan, China

Hunan Children's Hospital

Changsha, Hunan, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus

Hangzhou, Zhejiang, China

Children's Hospital Zagreb

Zagreb, City of Zagreb, Croatia

University Hospital Center Zagreb

Zagreb, City of Zagreb, Croatia

University Hospital of Split-Spinciceva 1

Split, Croatia

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha, Hlavni Mesto, Czechia

Fakultni Thomayerova Nemocnice

Prague, Praha, Hlavni Mesto, Czechia

University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

Athens, Attica, Greece

Children's Hospital Agia Sofia

Athens, Greece

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, Greece

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, Greece

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

Miskolc, Borsod-Abauj Zemplen county, Hungary

Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrád megye, Hungary

Clinexpert Obuda Egeszsegcentruma

Budapest, Hungary

Semmelweis Egyetem, Pulmonologiai Klinika

Budapest, Hungary

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Jerusalem, Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

Soroka University Medical Centre

Beersheba, Israel

Rambam Health Care Campus PPDS

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Hadassah Medical Center- Ein Kerem - PPDS

Jerusalem, Israel

Schneider Childrens Medical Center of Israel Petah Tikvah PIN

Petah Tikva, Israel

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2

Naples, Campania, Italy

Azienda USL di Bologna

Bologna, Emilia-Romagna, Italy

Sapienza University of Rome

Rome, Lazio, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy

Azienda Ospedaliero Universitaria A Meyer

Florence, Tuscany, Italy

Universita degli Studi di Padova

Padova, Veneto, Italy

Kurume University Hospital

Kurume-Shi, Hukuoka, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Saitama Children's Medical Center-1397-1 yamane

Hidaka, Saitama, Japan

Juntendo University Hospital

Bunkyo-Ku, Tokyo, Japan

National Center for Child Health and Development

Setagaya-Ku, Tokyo, Japan

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Kaunas County, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Vilnius County, Lithuania

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4

Wroclaw, Lower Silesian Voivodeship, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Masovian Voivodeship, Poland

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship, Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Podkarpackie Voivodeship, Poland

Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50

Gdansk, Pomeranian Voivodeship, Poland

Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach

Katowice, Silesian Voivodeship, Poland

Twoja Przychodnia SCM - Slowackiego

Szczecin, West Pomeranian Voivodeship, Poland

SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251

Lodz, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, Poland

Narodny ustav detskych chorob

Bratislava, Slovakia

Kyungpook National University Chilgok hospital

Daegu, Daegu Gwang'yeogsi, South Korea

Gachon University Gil Medical Center

Incheon, Incheon Gwang'yeogsi, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital de Sagunto

Sagunto, Valencia, Spain

Hospital Sant Joan de Deu - PIN

Barcelona, Spain

Hospital Infantil Universitario Nino Jesus - PIN

Madrid, Spain

Hospital Regional Universitario de Malaga Hospital Materno-Infantil

Málaga, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Great Ormond Street Hospital

London, London, City of, United Kingdom

Noahs Ark Childrens Hospital for Wales - PIN

Cardiff, South Glamorgan, United Kingdom

King's College Hospital

London, Surrey, United Kingdom

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, Warwickshire, United Kingdom

Barts Health NHS Trust - PPDS

London, United Kingdom

Royal Manchester Children's Hospital - PPDS - PIN

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05442567

Related Trials

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT0718494412 locations

A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice

NCT0696411319 locations

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

NCT0718500920 locations

An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab

NCT031674371 location

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931196 locations