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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: Vedolizumab IV; Other: No Intervention

Detailed Description

This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 [participants with UC] and MLN0002-3025 [participants with CD], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort.

Treatment Cohort:

The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD.

Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant. At this study entry, participants will be administered the same blinded dose of vedolizumab IV that was received at Week 46 in the parent study and will then continue to receive vedolizumab IV at a frequency of once every 8 weeks (Q8W) in the following treatment groups:

• Participants 10 to ≤15 kilogram (kg), Vedolizumab 150 milligram (mg) (High dose)
• Participants 10 to ≤15 kg, Vedolizumab 100 mg (Low dose)
• Participants >15 to <30 kg, Vedolizumab 200 mg (High dose)
• Participants >15 to <30 kg, Vedolizumab 100 mg (Low dose)
• Participants ≥30 kg, Vedolizumab 300 mg (High dose)
• Participants ≥30 kg, Vedolizumab 150 mg (Low dose)

Blinding of dose group assignment of the parent study will continue until the respective parent study is unblinded in order to protect the blinding of the parent study.

The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first. Participants who complete or are discontinued from the study for any reason will complete the final safety/end of study (EOS) visit 18 weeks after their last dose of study drug.

Observational Cohort:

Participants who received at least 1 dose of study drug during parent study and early terminated or are not eligible for the Treatment Cohort of this study after completion of the Week 54 visit of parent study, will be enrolled in the Observational Cohort of this study as part of a long-term follow-up period to assess prespecified safety events of interest and will not receive continued treatment with vedolizumab IV.

The overall time to participate in the Observational Cohort is up to approximately 2 years.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Children's Hospital at Westmead
      • Principal Investigator: Shoma Dutt
      • Contact: Site Contact
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Queensland Childrens Hospital
      • Contact: Site Contact
      • Principal Investigator: Christopher Burgess
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Not yet recruiting
      • Monash Health, Monash Medical Centre
      • Contact: Site Contact
      • Principal Investigator: Edward Giles
    • Parkville, Victoria, Australia, 3052
      • Recruiting
      • Royal Children's Hospital Melbourne - PIN
      • Principal Investigator: George Alex
      • Contact: Site Contact
• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • UZ Antwerpen - PIN
      • Principal Investigator: Els Van de Vijver
      • Contact: Site Contact
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • Recruiting
      • UZ Brussel - PIN
      • Principal Investigator: Elisabeth De Greef
      • Contact: Site Contact
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Principal Investigator: Ilse Hoffman
      • Contact: Site Contact
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Withdrawn
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Withdrawn
      • British Columbia Children's Hospital - 4480 Oak St
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Terminated
      • London Health Sciences Centre -800 Commissioners Rd E
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Withdrawn
      • Centre Hospitalier Universitaire Sainte-Justine
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100045
      • Not yet recruiting
      • Beijing Children's Hospital, Capital Medical University - PIN
      • Contact: Site Contact
      • Principal Investigator: Jie Wu
  • Henan
    • Zhengzhou, Henan, China, 450018
      • Recruiting
      • Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus
      • Principal Investigator: Xiaoqin Li
      • Contact: Site Contact
  • Hunan
    • Changsha, Hunan, China, 410007
      • Recruiting
      • Hunan Children's Hospital
      • Contact: Site Contact
      • Principal Investigator: Hongmei Zhao
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University
      • Principal Investigator: Ying Huang
      • Contact: Site Contact
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus
      • Principal Investigator: Jie Chen
      • Contact: Site Contact
• Croatia
  • Split, Croatia, 21000
    • Withdrawn
    • University Hospital of Split-Spinciceva 1
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10000
      • Recruiting
      • Children's Hospital Zagreb
      • Contact: Site Contact
      • Principal Investigator: Iva Hojsak
    • Zagreb, City of Zagreb, Croatia, 10000
      • Withdrawn
      • University Hospital Center Zagreb
• Czechia
  • Praha, Hlavni Mesto
    • Prague, Praha, Hlavni Mesto, Czechia, 100 34
      • Withdrawn
      • Fakultni nemocnice Kralovske Vinohrady
    • Prague, Praha, Hlavni Mesto, Czechia, 140 00
      • Withdrawn
      • Fakultni Thomayerova nemocnice
• Greece
  • Athens, Greece, GR11527
    • Recruiting
    • Children's Hospital Agia Sofia
    • Principal Investigator: Alexandra Papadopoulou
    • Contact: Site Contact
  • Thessaloniki, Greece, 546 42
    • Recruiting
    • General Hospital of Thessaloniki ''Hippokratio''
    • Principal Investigator: Ioannis Xinias
    • Contact: Site Contact
  • Thessaloniki, Greece, 546 42
    • Withdrawn
    • General Hospital of Thessaloniki ''Hippokratio''
  • Attica
    • Athens, Attica, Greece, 12462
      • Recruiting
      • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
      • Contact: Site Contact
      • Principal Investigator: Smaragdi Fessatou
• Hungary
  • Budapest, Hungary, 1033
    • Terminated
    • Clinexpert Obuda Egeszsegcentruma
  • Budapest, Hungary, 1083
    • Recruiting
    • Semmelweis Egyetem, Pulmonologiai Klinika
    • Principal Investigator: Aron Cseh
    • Contact: Site Contact
  • Borsod-Abauj Zemplen county
    • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
      • Recruiting
      • Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
      • Principal Investigator: Erzsebet Szakos
      • Contact: Site Contact
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6720
      • Withdrawn
      • Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika
• Israel
  • Beersheba, Israel, 84101
    • Withdrawn
    • Soroka University Medical Centre
  • Haifa, Israel, 34362
    • Recruiting
    • Carmel Medical Center
    • Contact: Site Contact
    • Principal Investigator: Reut Batcir
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Health Care Campus PPDS
    • Principal Investigator: Ron Shaoul
    • Contact: Site Contact
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center- Ein Kerem - PPDS
    • Contact: Site Contact
    • Principal Investigator: Zev Davidovics
  • Petah Tikva, Israel, 49100
    • Terminated
    • Schneider Childrens Medical Center of Israel Petah Tikvah PIN
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91031
      • Recruiting
      • Shaare Zedek Medical Center
      • Principal Investigator: Dan Turner
      • Contact: Site Contact
    • Jerusalem, Jerusalem, Israel, 90000
      • Recruiting
      • Tel Aviv Sourasky Medical Center Ichilov - PPDS
      • Principal Investigator: Shlomi Cohen
      • Contact: Site Contact
• Italy
  • Campania
    • Naples, Campania, Italy, 80131
      • Recruiting
      • Azienda Ospedaliera Universitaria Federico Ii
      • Principal Investigator: Erasmo Miele
      • Contact: Site Contact
    • Naples, Campania, Italy, 80131
      • Recruiting
      • Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2
      • Principal Investigator: Caterina Strisciuglio
      • Contact: Site Contact
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40133
      • Recruiting
      • Azienda USL di Bologna
      • Principal Investigator: Patrizia Alvisi
      • Contact: Site Contact
  • Lazio
    • Rome, Lazio, Italy, 185
      • Recruiting
      • Sapienza University of Rome
      • Contact: Site Contact
      • Principal Investigator: Salvatore Oliva
  • Lombardy
    • Monza, Lombardy, Italy, 20900
      • Terminated
      • Fondazione IRCCS San Gerardo Dei Tintori
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • Terminated
      • Azienda Ospedaliero Universitaria A Meyer
  • Veneto
    • Padova, Veneto, Italy, 35122
      • Withdrawn
      • Universita Degli Studi Di Padova
• Japan
  • Hukuoka
    • Kurume-Shi, Hukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital
      • Principal Investigator: Tatsuki Mizuochi
      • Contact: Site Contact
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 861-8520
      • Recruiting
      • Japanese Red Cross Kumamoto Hospital
      • Principal Investigator: Yugo Takaki
      • Contact: Site Contact
  • Saitama
    • Hidaka, Saitama, Japan, 330-8777
      • Recruiting
      • Saitama Children's Medical Center-1397-1 yamane
      • Contact: Site Contact
      • Principal Investigator: Itaru Iwama
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-8431
      • Recruiting
      • Juntendo University Hospital
      • Principal Investigator: Takahiro Kudo
      • Contact: Site Contact
    • Setagaya-Ku, Tokyo, Japan, 157-8535
      • Recruiting
      • National Center for Child Health and Development
      • Principal Investigator: Katsuhiro Arai
      • Contact: Site Contact
• Lithuania
  • Kaunas County
    • Kaunas, Kaunas County, Lithuania, LT-50161
      • Withdrawn
      • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Vilnius County
    • Vilnius, Vilnius County, Lithuania, 8406
      • Withdrawn
      • Vilnius University Hospital Santaros Klinikos
• Poland
  • Lodz, Poland, 91-738
    • Recruiting
    • SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
    • Principal Investigator: Ewa Toporowska-Kowalska
    • Contact: Site Contact
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-663
      • Recruiting
      • Uniwersytecki Szpital Dzieciecy w Krakowie
      • Principal Investigator: Kinga Kowalska-Duplaga
      • Contact: Site Contact
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-369
      • Withdrawn
      • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 04-736
      • Recruiting
      • Instytut Pomnik Centrum Zdrowia Dziecka
      • Principal Investigator: Jaroslaw Kierkus
      • Contact: Site Contact
    • Warsaw, Masovian Voivodeship, Poland, 04-501
      • Recruiting
      • WIP Warsaw IBD Point Profesor Kierkus
      • Principal Investigator: Monika Meglicka
      • Contact: Site Contact
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
      • Recruiting
      • Korczowski Bartosz, Gabinet Lekarski
      • Principal Investigator: Bartosz Korczowski
      • Contact: Site Contact
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-803
      • Withdrawn
      • Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-752
      • Withdrawn
      • Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
      • Recruiting
      • Twoja Przychodnia SCM - Slowackiego
      • Principal Investigator: Beata Gawdis-Wojnarska
      • Contact: Site Contact
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 93-338
      • Recruiting
      • Instytut Centrum Zdrowia Matki Polki
      • Principal Investigator: Elzbieta Czkwianianc
      • Contact: Site Contact
• Slovakia
  • Bratislava, Slovakia, 833 40
    • Withdrawn
    • Narodny ustav detskych chorob
• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Jin Soo Moon
    • Contact: Site Contact
  • Seoul, South Korea, 6351
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Yon-Ho Choe
    • Contact: Site Contact
  • Daegu Gwang'yeogsi
    • Daegu, Daegu Gwang'yeogsi, South Korea, 41404
      • Recruiting
      • Kyungpook National University Chilgok Hospital
      • Principal Investigator: Ben Kang
      • Contact: Site Contact
  • Incheon Gwang'yeogsi
    • Incheon, Incheon Gwang'yeogsi, South Korea, 21565
      • Terminated
      • Gachon University Gil Medical Center
• Spain
  • Barcelona, Spain, 8950
    • Withdrawn
    • Hospital Sant Joan de Deu - PIN
  • Madrid, Spain, 28009
    • Withdrawn
    • Hospital Infantil Universitario Niño Jesus - PIN
  • Málaga, Spain, 29011
    • Withdrawn
    • Hospital Regional Universitario de Malaga Hospital Materno-Infantil
  • Seville, Spain, 41013
    • Withdrawn
    • Hospital Universitario Virgen del Rocio - PPDS
  • Valencia
    • Sagunto, Valencia, Spain, 46520
      • Withdrawn
      • Hospital de Sagunto
• United Kingdom
  • London, United Kingdom, E1 1BB
    • Not yet recruiting
    • Barts Health NHS Trust - PPDS
    • Contact: Site Contact
    • Principal Investigator: Sandhia Naik
  • Manchester, United Kingdom, M27 4HA
    • Withdrawn
    • Royal Manchester Children's Hospital - PPDS - PIN
  • London, City of
    • London, London, City of, United Kingdom, WC1N 3AJ
      • Withdrawn
      • Great Ormond Street Hospital
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
      • Withdrawn
      • Noahs Ark Childrens Hospital for Wales - PIN
  • Surrey
    • London, Surrey, United Kingdom, SE5 9RS
      • Withdrawn
      • King's College Hospital
  • Warwickshire
    • Birmingham, Warwickshire, United Kingdom, B4 6NH
      • Recruiting
      • Birmingham Women's and Children's NHS Foundation Trust
      • Principal Investigator: Rafeeq Muhammed
      • Contact: Site Contact
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Not yet recruiting
      • University of South Alabama (USA) Physicians Group
      • Contact: Site Contact
      • Principal Investigator: David Gremse
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Childrens Hospital - Thomas Rd - PIN
      • Principal Investigator: Ashish Patel
      • Contact: Site Contact
  • California
    • Los Angeles, California, United States, 90048
      • Withdrawn
      • Cedars Sinai Medical Center - 127 San Vicente Blvd
    • San Diego, California, United States, 92123
      • Not yet recruiting
      • Rady Children's Hospital - San Diego - PIN
      • Contact: Site Contact
      • Principal Investigator: Jeannie Huang
    • San Francisco, California, United States, 94158
      • Withdrawn
      • University of California San Francisco
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Withdrawn
      • I.H.S Health LLC-Kissimmee-445 W Oak St
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Not yet recruiting
      • Childrens Center For Digestive Healthcare
      • Contact: Site Contact
      • Principal Investigator: Benjamin Gold
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Advocate Children's Hospital - Park Ridge - PIN
      • Contact: Site Contact
      • Principal Investigator: Kiranmai Gorla
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Withdrawn
      • Riley Hospital For Children - PIN
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Withdrawn
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Withdrawn
      • Boston Children's Hospital - PIN
  • Minnesota
    • Minneapolis, Minnesota, United States, 55413
      • Terminated
      • MNGI Digestive Health PA-Plymouth
    • Rochester, Minnesota, United States, 55905
      • Terminated
      • Mayo Clinic - PIN
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Terminated
      • Goryeb Children's Hospital
  • New York
    • New Hyde Park, New York, United States, 11042
      • Withdrawn
      • Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN
    • Rochester, New York, United States, 14642
      • Withdrawn
      • University of Rochester Medical Center - PPDS
    • Stony Brook, New York, United States, 11794
      • Withdrawn
      • Stony Brook University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • University Hospitals Cleveland Medical Center - 11100 Euclid Ave
      • Contact: Site Contact
      • Principal Investigator: Thomas Sferra
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15201
      • Withdrawn
      • UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Withdrawn
      • Hasbro Children's Hospital - PIN
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Texas Children's Hospital - Baylor - PIN
      • Principal Investigator: Faith Ihekweazu
      • Contact: Site Contact
  • Virginia
    • Roanoke, Virginia, United States, 24018
      • Recruiting
      • Carilion Children's Tanglewood Center
      • Contact: Site Contact
      • Principal Investigator: Monica Garin-Laflam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Observational Cohort: Early Terminated Participants From Parent Studies; Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.	Other: No Intervention; Participants will not receive any intervention in the Observational Cohort.
Experimental: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg; Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.	Drug: Vedolizumab IV; Vedolizumab IV infusion; Other Names: MLN0002; ENTYVIO; KYNTELES
Experimental: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg; Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.	Drug: Vedolizumab IV; Vedolizumab IV infusion; Other Names: MLN0002; ENTYVIO; KYNTELES
Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg; Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing >15 to <30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.	Drug: Vedolizumab IV; Vedolizumab IV infusion; Other Names: MLN0002; ENTYVIO; KYNTELES
Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg; Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing >15 to <30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.	Drug: Vedolizumab IV; Vedolizumab IV infusion; Other Names: MLN0002; ENTYVIO; KYNTELES
Experimental: Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg; Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.	Drug: Vedolizumab IV; Vedolizumab IV infusion; Other Names: MLN0002; ENTYVIO; KYNTELES
Experimental: Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg; Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.	Drug: Vedolizumab IV; Vedolizumab IV infusion; Other Names: MLN0002; ENTYVIO; KYNTELES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to drug.	From first dose of study drug up to approximately 5 years
Observational Cohort: Number of Participants With Prespecified Safety Events	Prespecified safety events will include serious infections, malignancies, progressive multifocal leukoencephalopathy (PML), concerns about growth and pubertal development, and bowel surgery.	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events	Major IBD-related events include hospitalizations, surgeries, and procedures in pediatric participants with UC or CD.	Up to approximately 5 years
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Total Score for Participants Aged 9 to 17 Years for Every 24 Weeks	The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The total score is an average of all item scores. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.	Baseline, every 24 weeks in this study (up to approximately 5 years)
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks	The IMPACT-III Bowel Symptom Subscale is a self-reported measure with 7 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The bowel symptom subscale score ranges from 1 to 35, with higher scores indicating lesser bowel symptoms. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.	Baseline, every 24 weeks in this study (up to approximately 5 years)
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Systemic Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks	The IMPACT-III Systemic Symptom Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The Systemic symptom subscale score ranges from 1 to 15, with higher scores indicating lesser systemic symptoms. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.	Baseline, every 24 weeks in this study (up to approximately 5 years)
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Social Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks	The IMPACT-III Social Functioning Subscale is a self-reported measure with 12 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The social functioning subscale score ranges from 1 to 60, with higher scores indicating better social functioning. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.	Baseline, every 24 weeks in this study (up to approximately 5 years)
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks	The IMPACT-III Body Image Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The body image subscale score ranges from 1 to 15, with higher scores indicating better body image. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.	Baseline, every 24 weeks in this study (up to approximately 5 years)
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks	The IMPACT-III Treatment/Intervention Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The treatment/intervention subscale score ranges from 1 to 15, with higher scores indicating ease of administration of treatment/interventions. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.	Baseline, every 24 weeks in this study (up to approximately 5 years)
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks	The IMPACT-III Emotional Functioning Subscale is a self-reported measure with 7 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The emotional functioning subscale score ranges from 1 to 35, with higher scores indicating better emotional functioning. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.	Baseline, every 24 weeks in this study (up to approximately 5 years)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): February 7, 2033
• Study Completion (Estimated): February 7, 2033

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease; Gastrointestinal Agents; vedolizumab
• Other Study ID Numbers: MLN0002-3029; jRCT2071230036 (Registry Identifier: jRCT); 2023-509046-36-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No