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RECRUITING

NCT05442567

PHASE3

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-05-16

Completion Date

2031-08-15

Last Updated

2025-04-09

Healthy Volunteers

Conditions

Ulcerative Colitis Crohn's Disease

Interventions

DRUG

Vedolizumab IV

Vedolizumab IV infusion

OTHER

No Intervention

Participants will not receive any intervention in the Observational Cohort.

Main Inclusion Criteria: For Treatment Cohort: 1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30. 2. A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception. 3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose. For Observational Cohort: 1\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study. Main Exclusion Criteria: For Treatment Cohort only: 1. The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study. 2. The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety. 3. The participant has other serious comorbidities that will limit their ability to complete the study. 4. The participant is unable to comply with all study assessments. 5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients. 6. The participant is lactating or pregnant.

Locations (68)

Phoenix Childrens Hospital -1919 E Thompson Rd

Phoenix, Arizona, United States

Rady Childrens Hospital San Diego - PIN

San Diego, California, United States

Childrens Center For Digestive Healthcare

Atlanta, Georgia, United States

Advocate Children's Hospital Park Ridge

Park Ridge, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Children's Hospital

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

The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS

New Hyde Park, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Texas Children's Hospital

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

Edegem, Antwerpen, Belgium

Universitair Ziekenhuis Brussel - PIN

Jette, Brussels Capital, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

University of Alberta Hospital

Edmonton, Alberta, Canada

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

Beijing Children Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Henan Children's Hospital (Zhengzhou Children's Hospital)

Zhengzhou, Henan, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The Children's Hospital Zhejiang UniversitySchool of Medicine

Hangzhou, Zhejiang, China

Klinika Za Djecje Bolesti Zagreb

Zagreb, City of Zagreb, Croatia

Attikon University General Hospital

Athens, Attica, Greece

Children's Hospital "Agia Sofia"

Athens, Greece

Ippokratio General Hospital of Thessaloniki

Thessaloniki, Greece

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, Borsod-Abauj Zemplen county, Hungary

Semmelweis Egyetem

Budapest, Hungary

Schneider Childrens Medical Center of Israel Petah Tikvah PIN

Petah Tikva, Central District, Israel

Hadassah Medical Center - PPDS

Jerusalem, Jerusalem, Israel

Rambam Medical Center - PPDS

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, Israel

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli

Naples, Campania, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, Italy

Azienda USL di Bologna

Bologna, Emilia-Romagna, Italy

Sapienza University of Rome

Rome, Lazio, Italy

Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo

Monza, Lombardy, Italy

Universita degli Studi di Padova

Padova, Veneto, Italy

Kurume University Hospital

Kurume-Shi, Hukuoka, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Juntendo University Hospital

Bunkyo-Ku, Tokyo, Japan

National Center for Child Health and Development

Setagaya-Ku, Tokyo, Japan

Uniwersytecki Szpital Dzieciecy

Krakow, Lesser Poland 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

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

Katowice, Silesian Voivodeship, Poland

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, Poland

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

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 - PPDS

Seoul, South Korea

Great Ormond Street Hospital (GOSH)

London, London, City of, United Kingdom

Noahs Ark Childrens Hospital for Wales - PPDS - PIN

Cardiff, South Glamorgan, United Kingdom

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Royal Manchester Children's Hospital - PPDS

Manchester, United Kingdom