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

March 5, 2024 updated by: Takeda

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

Intervention / Treatment

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 final database lock of the parent study 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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Children's Hospital at Westmead
        • Contact:
        • Principal Investigator:
          • Shoma Dutt
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Not yet recruiting
        • Queensland Childrens Hospital
        • Contact:
        • Principal Investigator:
          • Peter Lewindon
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Not yet recruiting
        • Monash Health, Monash Medical Centre
        • Contact:
        • Principal Investigator:
          • Gregory Moore
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • Royal Children's Hospital Melbourne - PIN
        • Principal Investigator:
          • George Alex
        • Contact:
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Not yet recruiting
        • UZ Antwerpen
        • Contact:
        • Principal Investigator:
          • Els Van de Vijver
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • Not yet recruiting
        • Universitair Ziekenhuis Brussel - PIN
        • Contact:
        • Principal Investigator:
          • Elisabeth De Greef
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Ilse Hoffman
        • Contact:
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, AB T6G 2B7
        • Not yet recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Hien Huynh
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H3V4
        • Not yet recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kevan Jacobson
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Not yet recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Kevin Bax
  • China
    • Beijing
      • Beijing, Beijing, China, 100045
        • Not yet recruiting
        • Beijing Children Hospital,Capital Medical University
        • Contact:
        • Principal Investigator:
          • Jie Wu
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Children's Hospital (Zhengzhou Children's Hospital)
        • Contact:
        • Principal Investigator:
          • Xiaoqin Li
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Principal Investigator:
          • Ying Huang
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The Children's Hospital Zhejiang UniversitySchool of Medicine
        • Principal Investigator:
          • Jie Chen
        • Contact:
  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Recruiting
        • Klinika Za Djecje Bolesti Zagreb
        • Contact:
        • Principal Investigator:
          • Iva Hojsak
  • Greece
      • Athens, Greece
        • Not yet recruiting
        • Children's Hospital "Agia Sofia"
        • Contact:
        • Principal Investigator:
          • Alexandra Papadopoulou
      • Thessaloniki, Greece, 546 42
        • Recruiting
        • Ippokratio General Hospital of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Ioannis Xinias
    • Attiki
      • Athens, Attiki, Greece, 124 62
        • Not yet recruiting
        • Attikon University General Hospital
        • Contact:
        • Principal Investigator:
          • Vassiliki Papaevangelou
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Semmelweis Egyetem
        • Contact:
        • Principal Investigator:
          • Aron Cseh
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
        • Not yet recruiting
        • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
        • Contact:
        • Principal Investigator:
          • Erzsebet Szakos
  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Ron Shaoul
      • Haifa, Israel, 34362
        • Not yet recruiting
        • Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Corina Hartman
      • Jerusalem, Israel, 91031
        • Not yet recruiting
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Dan Turner
        • Contact:
      • Tel-Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center PPDS
        • Principal Investigator:
          • Shlomi Cohen
        • Contact:
    • HaMerkaz
      • Petah Tikva, HaMerkaz, Israel, 49202
        • Not yet recruiting
        • Schneider Childrens Medical Center of Israel Petah Tikvah PIN
        • Contact:
        • Principal Investigator:
          • Raanan Shamir
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Recruiting
        • Hadassah Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Zev Davidovics
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Not yet recruiting
        • AOU dell'Università degli Studi della Campania Luigi Vanvitelli
        • Contact:
        • Principal Investigator:
          • Caterina Strisciuglio
      • Napoli, Campania, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Contact:
        • Principal Investigator:
          • Erasmo Miele
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40133
        • Recruiting
        • Azienda USL di Bologna
        • Contact:
        • Principal Investigator:
          • Patrizia Alvisi
    • Lazio
      • Roma, Lazio, Italy, 161
        • Not yet recruiting
        • Sapienza University of Rome
        • Principal Investigator:
          • Marina Aloi
        • Contact:
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo
        • Principal Investigator:
          • Roberto Panceri
        • Contact:
    • Veneto
      • Padova, Veneto, Italy, 35122
        • Not yet recruiting
        • Universita degli Studi di Padova
        • Contact:
        • Principal Investigator:
          • Mara Cananzi
  • Japan
    • Hukuoka
      • Kurume-Shi, Hukuoka, Japan, 830-0011
        • Not yet recruiting
        • Kurume University Hospital
        • Contact:
        • Principal Investigator:
          • Tatsuki Mizuochi
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 861-8520
        • Not yet recruiting
        • Japanese Red Cross Kumamoto Hospital
        • Contact:
        • Principal Investigator:
          • Yugo Takaki
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8431
        • Not yet recruiting
        • Juntendo University Hospital
        • Principal Investigator:
          • Takahiro Kudo
        • Contact:
      • Setagaya-Ku, Tokyo, Japan, 157-8535
        • Not yet recruiting
        • National Center for Child Health and Development
        • Contact:
        • Principal Investigator:
          • Katsuhiro Arai
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jin Soo Moon
        • Contact:
      • Seoul, Korea, Republic of, 6351
        • Not yet recruiting
        • Samsung Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Yon-Ho Choe
    • Daegu Gwang'yeogsi
      • Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 41404
        • Not yet recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Ben Kang
        • Contact:
    • Incheon Gwang'yeogsi
      • Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
        • Not yet recruiting
        • Gachon University Gil Medical Center
        • Contact:
        • Principal Investigator:
          • Eell Ryoo
  • Poland
      • Lodz, Poland, 91-738
        • Not yet recruiting
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
        • Contact:
        • Principal Investigator:
          • Ewa Toporowska-Kowalska
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-338
        • Not yet recruiting
        • Instytut Centrum Zdrowia Matki Polki
        • Contact:
        • Principal Investigator:
          • Elzbieta Czkwianianc
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-663
        • Not yet recruiting
        • Uniwersytecki Szpital Dzieciecy
        • Contact:
        • Principal Investigator:
          • Kinga Kowalska-Duplaga
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-728
        • Not yet recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
        • Contact:
        • Principal Investigator:
          • Monika Meglicka
      • Warszawa, Mazowieckie, Poland, 04-736
        • Not yet recruiting
        • Instytut Pomnik Centrum Zdrowia Dziecka
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-302
        • Not yet recruiting
        • Korczowski Bartosz, Gabinet Lekarski
        • Principal Investigator:
          • Bartosz Korczowski
        • Contact:
    • Slaskie
      • Katowice, Slaskie, Poland, 40-752
        • Not yet recruiting
        • Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
        • Contact:
        • Principal Investigator:
          • Urszula Grzybowska-Chlebowczyk
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia Scm
        • Principal Investigator:
          • Beata Gawdis-Wojnarska
        • Contact:
  • Slovakia
      • Bratislava, Slovakia, 833 40
        • Not yet recruiting
        • Narodny ustav detskych chorob
        • Contact:
        • Principal Investigator:
          • Iveta Cierna
  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Not yet recruiting
        • Barts Health NHS Trust
        • Contact:
        • Principal Investigator:
          • Marco Gasparetto
      • Manchester, United Kingdom, M27 4HA
        • Not yet recruiting
        • Royal Manchester Children's Hospital - PPDS
        • Contact:
        • Principal Investigator:
          • Andrew (Sunday) Fagbemi
    • London, City Of
      • London, London, City Of, United Kingdom, WC1N 3AJ
        • Not yet recruiting
        • Great Ormond Street Hospital (GOSH)
        • Contact:
        • Principal Investigator:
          • Kelsey Jones
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
        • Not yet recruiting
        • Noahs Ark Childrens Hospital for Wales - PPDS - PIN
        • Contact:
        • Principal Investigator:
          • Amar Wahid
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Not yet recruiting
        • Birmingham Children's Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Rafeeq Muhammed
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Recruiting
        • Phoenix Childrens Hospital -1919 E Thompson Rd
        • Contact:
        • Principal Investigator:
          • Ashish Patel
    • California
      • San Diego, California, United States, 92123-4223
        • Not yet recruiting
        • Rady Childrens Hospital San Diego - PIN
        • Contact:
        • Principal Investigator:
          • Ying Huang
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Not yet recruiting
        • Childrens Center For Digestive Healthcare
        • Contact:
        • Principal Investigator:
          • Shlomi Cohen
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Advocate Children's Hospital Park Ridge
        • Contact:
        • Principal Investigator:
          • Thirumazhisai S. Gunasekaran
    • Maryland
      • Baltimore, Maryland, United States, 21287-0005
        • Not yet recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Maria Oliva-Hemker
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5724
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
        • Recruiting
        • MNGI Digestive Health PA-Plymouth
        • Contact:
        • Principal Investigator:
          • Ramalingam Arumugam
      • Rochester, Minnesota, United States, 55905-0001
        • Not yet recruiting
        • Mayo Clinic - PIN
        • Contact:
        • Principal Investigator:
          • Michael Stephens
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6136
        • Not yet recruiting
        • Goryeb Children's Hospital
        • Contact:
        • Principal Investigator:
          • Joel Rosh
    • New York
      • New Hyde Park, New York, United States, 11042-2062
        • Not yet recruiting
        • The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
        • Contact:
        • Principal Investigator:
          • James Markowitz
    • Ohio
      • Cleveland, Ohio, United States, 44106-1716
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Jonathan Moses
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15201
        • Not yet recruiting
        • Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Whitney Sunseri
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Faith Ihekweazu
    • Virginia
      • Roanoke, Virginia, United States, 24018-0720
        • Not yet recruiting
        • Carilion Children's Tanglewood Center
        • Contact:
        • Principal Investigator:
          • Juan Olazagasti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 barrier method of contraception (e.g., condom with or without spermicide) from signing of informed consent 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 informed consent 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: From first dose of study drug up to approximately 5 years
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
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 5 years
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
Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
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
Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
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
Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
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
Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
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
Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
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
Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
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
Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
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

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Estimated)

August 15, 2031

Study Completion (Estimated)

August 15, 2031

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)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLN0002-3029
  • 2021-000630-34 (EudraCT Number)
  • jRCT2071230036 (Registry Identifier: jRCT)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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