A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

April 18, 2024 updated by: Takeda

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.

The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease.

The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis.

Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC. Participants to be enrolled must have failed response to, lost response to, or been intolerant to at least 1 of the current standard of care (SOC) induction and maintenance therapies for UC including immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists (eg, infliximab, adalimumab).

The study will enroll approximately 120 patients.

During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline:

  • Participants ≥30 kg, Vedolizumab 300 mg
  • Participants >15 to <30 kg, Vedolizumab 200 mg
  • Participants 10 to 15 kg, Vedolizumab 150 mg

At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and weight. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows:

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

The dose will remain blinded to the participant and study doctor and staff during the study (unless there is an urgent medical need). All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed during Maintenance period.

This multi-center trial will be conducted worldwide. After the Week 54 visit, participants who are younger than 18 years may be eligible to continue receiving vedolizumab in extension study MLN0002-3029 (NCT05442567). Participants who do not maintain corticosteroid-free clinical response at Week 54 or who discontinue study drug at any time during the induction or maintenance periods of this study will undergo an end of study (EOS) or early termination (ET) visit, as well as a safety visit 18 weeks after the last dose of vedolizumab, in addition these participants would enter study MLN0002-3029 for an observational long-term follow-up (LTFU) period of 2 years after the last dose of study drug in the current study. During the LTFU period, data will be collected either by clinic visit OR, if site attendance is not feasible, by phone call every 6 months.

Study Type

Interventional

Enrollment (Estimated)

120

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
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • 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
        • Recruiting
        • UZ Antwerpen
        • Contact:
        • Principal Investigator:
          • Els Van de Vijver
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel - PIN
        • Contact:
        • Principal Investigator:
          • Elisabeth De Greef
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg
        • Principal Investigator:
          • Ilse Hoffman
        • Contact:
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2S2
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Hien Huynh
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kevan Jacobson
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Principal Investigator:
          • Kevin Bax
        • Contact:
  • China
    • Beijing
      • Beijing, Beijing, China, 100045
        • Recruiting
        • Beijing Children's Hospital, Capital Medical University - PIN
        • Principal Investigator:
          • Jie Wu
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Children's Hospital Zhengzhou Children's Hospital
        • Principal Investigator:
          • Xiaoqin Li
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Principal Investigator:
          • Ying Huang
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The Children's Hospital Zhejiang University School of Medicine
        • Principal Investigator:
          • Jie Chen
        • Contact:
  • Croatia
      • Split, Croatia, 21000
        • Recruiting
        • University Hospital of Split
        • Contact:
        • Principal Investigator:
          • Ranka Despot
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Recruiting
        • Klinika Za Djecje Bolesti Zagreb
        • Contact:
        • Principal Investigator:
          • Iva Hojsak
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital Center Zagreb - Kispaticeva 12
        • Contact:
        • Principal Investigator:
          • Jurica Vukovic
  • Czechia
      • Praha, Czechia, 100 34
        • Recruiting
        • Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS
        • Principal Investigator:
          • Vladimir Volf
        • Contact:
      • Praha, Czechia, 140 59
        • Recruiting
        • Fakultni Thomayerova Nemocnice - CRC - PPDS
        • Contact:
        • Principal Investigator:
          • Radim Vyhnanek
  • Greece
      • Thessaloniki, Greece, 546 42
        • Recruiting
        • Ippokratio General Hospital of Thessaloniki
        • Principal Investigator:
          • Ioannis Xinias
        • Contact:
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Recruiting
        • Children's Hospital "Agia Sofia"
        • Contact:
        • Principal Investigator:
          • Alexandra Papadopoulou
      • Chaidari, Attiki, Greece, 124 62
        • Recruiting
        • Attikon University General Hospital
        • Contact:
        • Principal Investigator:
          • Smaragdi Fessatou
  • Hungary
      • Budapest, Hungary, 1085
      • Budapest, Hungary, 1033
        • Recruiting
        • Clinexpert Gyogycentrum
        • Contact:
        • Principal Investigator:
          • Natalia Lasztity
      • Miskolc, Hungary, 3526
        • Recruiting
        • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
        • Contact:
        • Principal Investigator:
          • Erzsebet Szakos
  • Israel
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Yigal Elenberg
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Medical Center - PPDS
        • Principal Investigator:
          • Ron Shaoul
        • Contact:
      • Petah Tikva, Israel, 49100
        • Recruiting
        • Schneider Childrens Medical Center of Israel Petah Tikvah PIN
        • Principal Investigator:
          • Dror Shouval
        • Contact:
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Shlomi Cohen
        • Contact:
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 84101
        • Recruiting
        • Soroka Medical Center
        • Contact:
        • Principal Investigator:
          • Baruch Yerushalmi
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Recruiting
        • Hadassah Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Zev Davidovics
      • Jerusalem, Yerushalayim, Israel, 91031
        • Recruiting
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Dan Turner
        • Contact:
  • Italy
      • Napoli, Italy, 280138
        • Recruiting
        • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2
        • Principal Investigator:
          • Caterina Strisciuglio
        • Contact:
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Contact:
        • Principal Investigator:
          • Erasmo Miele
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40133
        • Recruiting
        • Azienda USL di Bologna
        • Principal Investigator:
          • Patrizia Alvisi
        • Contact:
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
        • Principal Investigator:
          • Marina Aloi
        • Contact:
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo
        • Principal Investigator:
          • Roberto Panceri
        • Contact:
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • Recruiting
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
        • Principal Investigator:
          • Paolo Lionetti
        • Contact:
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Azienda Ospedale Universita Padova
        • Principal Investigator:
          • Mara Cananzi
        • Contact:
  • Japan
      • Kumamoto, Japan, 861-8520
        • Recruiting
        • Japanese Red Cross Kumamoto Hospital
        • Contact:
        • Principal Investigator:
          • Yugo Takaki
      • Saitama, Japan, 330-8777
        • Recruiting
        • Saitama Children's Medical Center
        • Contact:
        • Principal Investigator:
          • Itaru Iwama
    • Hukuoka
      • Kurume, Hukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
        • Principal Investigator:
          • Tatsuki Mizuochi
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Principal Investigator:
          • Takahiro Kudo
        • Contact:
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • Recruiting
        • National Center for Child Health and Development
        • Contact:
        • Principal Investigator:
          • Katsuhiro Arai
  • Korea, Republic of
    • Daegu Gwang'yeogsi
      • Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Ben Kang
        • Contact:
    • Incheon Gwang'yeogsi
      • Seoul, Incheon Gwang'yeogsi, Korea, Republic of, 3080
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Eell Ryoo
        • Contact:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Yon-Ho Choe
        • Contact:
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 21565
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jin Soo Moon
        • Contact:
  • Poland
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-338
        • Recruiting
        • Instytut Centrum Zdrowia Matki Polki
        • Contact:
        • Principal Investigator:
          • Elzbieta Czkwianianc
      • Lodz, Lodzkie, Poland, 91-738
        • Recruiting
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
        • Contact:
        • Principal Investigator:
          • Ewa Toporowska-Kowalska
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-663
        • Recruiting
        • Uniwersytecki Szpital Dzieciecy
        • Principal Investigator:
          • Kinga Kowalska-Duplaga
        • Contact:
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-728
        • Recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
        • Principal Investigator:
          • Monika Meglicka
        • Contact:
      • Warszawa, Mazowieckie, Poland, 04-736
        • Recruiting
        • Instytut 'Pomnik - Centrum Zdrowia Dziecka'
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-302
        • Recruiting
        • Korczowski Bartosz, Gabinet Lekarski
        • Principal Investigator:
          • Bartosz Korczowski
        • Contact:
    • Slaskie
      • Katowice, Slaskie, Poland, 40-752
        • 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:
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Noahs Ark Childrens Hospital for Wales
        • Principal Investigator:
          • Amar Wahid
        • Contact:
    • London, City Of
      • London, London, City Of, United Kingdom, E1 1BB
        • Recruiting
        • The Royal London Hospital
        • Contact:
        • Principal Investigator:
          • Sandhia Naik
      • London, London, City Of, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital
        • Contact:
        • Principal Investigator:
          • Kelsey Jones
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Women's and Children's NHS Foundation Trust
        • Principal Investigator:
          • Rafeeq Muhammed
        • Contact:
  • 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
        • Recruiting
        • Rady Childrens Hospital San Diego - PIN
        • Principal Investigator:
          • Jeannie Huang
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30318-4833
        • Recruiting
        • Childrens Center For Digestive Healthcare
        • Contact:
        • Principal Investigator:
          • Benjamin Gold
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Children's Hospital Park Ridge
        • Contact:
        • Principal Investigator:
          • Kiranmai Gorla
    • Maryland
      • Baltimore, Maryland, United States, 21287-0005
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Maria Oliva-Hemker
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
        • Recruiting
        • MNGI Digestive Health PA-Plymouth
        • Contact:
        • Principal Investigator:
          • Ramalingam Arumugam
      • Rochester, Minnesota, United States, 55905-0001
        • Recruiting
        • Mayo Clinic - PIN
        • Contact:
        • Principal Investigator:
          • Michael Stephens
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6136
        • Recruiting
        • Goryeb Children's Hospital
        • Contact:
        • Principal Investigator:
          • Alycia Leiby
    • New York
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
        • Principal Investigator:
          • James Markowitz
        • Contact:
      • Stony Brook, New York, United States, 11794-0001
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center - 11100 Euclid Ave
        • Principal Investigator:
          • Thomas Sferra
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224-1334
        • Recruiting
        • UPMC Children's Hospital of Pittsburgh-120 Lytton Ave
        • Contact:
        • Principal Investigator:
          • Whitney Sunseri
    • Texas
      • Houston, Texas, United States, 77030-2358
        • Recruiting
        • Texas Childrens Hospital West Campus
        • Contact:
        • Principal Investigator:
          • Faith Ihekweazu
    • Virginia
      • Roanoke, Virginia, United States, 24013-2253
        • 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

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).
  2. Weighs ≥10 kg at the time of screening and enrollment into the study.
  3. Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on 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) at screening endoscopy.
  4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.
  5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
  6. Has 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.
  7. Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.

Exclusion Criteria:

  1. Has 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 or rituximab.
  2. Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
  3. Has active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
  4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
  5. Has received any live vaccinations within 30 days prior to first dose of study drug.
  6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
  7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
  8. Participants with a current diagnosis of indeterminate colitis.
  9. Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease.

  10. Participant with active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening period that is positive, defined as:

    • Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
    • A TB skin test reaction ≥5 mm. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.

  11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie, hepatitis B surface antigen [HBsAg]-negative and hepatitis B antibody-positive) may, however, be included. Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.

    Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA). Note: Subjects who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks before baseline]).

  12. The participant has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
  13. Has positive stool studies for ova and/or parasites or stool culture at screening visit.
  14. Has positive Clostridioides difficile (C difficile) stool test at screening visit.

Other inclusion/exclusion criteria may apply.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Induction Period: Participants ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg are included in this arm.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Clinical Remission at Week 54 Based on Modified Mayo Score
Time Frame: Week 54
Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
Week 54

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Clinical Remission at Week 14 Based on Modified Mayo Score
Time Frame: Week 14
Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
Week 14
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on Modified Mayo Score
Time Frame: Week 54
Sustained clinical remission is where a participant achieves clinical remission at Weeks 14 and 54, based on the modified Mayo score. It is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
Week 54
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 54
Time Frame: Week 54
Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 54, and was off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
Week 54
Percentage of Participants with Clinical Remission at Week 54 Based on Complete Mayo Score
Time Frame: Week 54
Clinical remission based on the complete Mayo score is where a participant achieved a complete Mayo score ≤2 points with no individual subscore >1 at Week 54. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.
Week 54
Percentage of Participants with Positive Anti-vedolizumab Antibodies (AVA)
Time Frame: Predose (up to 54 weeks)
Predose (up to 54 weeks)
Percentage of Participants with Clinical Response up to Week 54 Based on Partial Mayo Score
Time Frame: Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical response is defined as reduction of ≥2 points and ≥25% from the Baseline partial Mayo score, including a ≥1-point decrease in the Mayo stool frequency subscore and a ≥1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of ≤1 point. Partial Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Higher score indicates more severe disease.
Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Percentage of Participants with at least One Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
Time Frame: Up to 158 weeks
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug which does not necessarily have to have a causal relationship with the treatment. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect and/or is a important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to Takeda may be appropriate. AESIs include: infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]).
Up to 158 weeks
Change from Baseline in Weight
Time Frame: Baseline, up to Week 54
Change from in Baseline in weight will be calculated as: Weight at each study visit (up to Week 54) - Weight at Baseline.
Baseline, up to Week 54
Change from Baseline in Linear Growth Z-score
Time Frame: Baseline, up to Week 54
Linear growth Z-score will be calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population.
Baseline, up to Week 54
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on Modified Mayo Score
Time Frame: Week 14
Sustained clinical remission is where a participant achieves clinical remission at Weeks 14 and 54, based on the modified Mayo score. It is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
Week 14
Percentage of Participants with Sustained Endoscopic Remission at Week 14
Time Frame: Week 14
Sustained endoscopic remission was defined as Mayo endoscopic score (MES) of ≤1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
Week 14
Percentage of Participants with Sustained Endoscopic Remission at Week 54
Time Frame: Week 54
Sustained endoscopic remission was defined as Mayo endoscopic score (MES) of ≤1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
Week 54
Percentage of Participants with Endoscopic Response at Week 14
Time Frame: Week 14
Endoscopic response was defined as a decrease in MES by ≥1 grade. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
Week 14
Percentage of Participants with Endoscopic Response at Week 54
Time Frame: Week 54
Endoscopic response was defined as a decrease in MES by ≥1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
Week 54
Serum Trough Concentrations of Vedolizumab over Time
Time Frame: Predose and postdose at multiple time points (up to 54 weeks)
Predose and postdose at multiple time points (up to 54 weeks)
Percentage of Participants with Positive Neutralizing AVA
Time Frame: Predose (up to 54 weeks)
Predose (up to 54 weeks)
Percentage of Participants with Sustained Clinical Response at Week 14 Based on Complete Mayo Score
Time Frame: Week 14
Clinical response is where a participant has a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.
Week 14
Percentage of Participants with Sustained Clinical Response at Week 54 Based on Complete Mayo Score
Time Frame: Week 54
Clinical response is where a participant has a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.
Week 54
Percentage of Participants with Clinical Remission up to Week 54 Based on Partial Mayo Score
Time Frame: Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
A partial Mayo score ≤2 points and no individual subscore >1 point.
Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change in Tanner Stage at Week 54 Compared with Baseline
Time Frame: Week 54
Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants are evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages.
Week 54

Collaborators and Investigators

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

Sponsor

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)

April 18, 2022

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLN0002-3024
  • 2020-004300-34 (EudraCT Number)
  • jRCT2071210030 (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

product manufactured in and exported from the U.S.

Yes

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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