A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

April 10, 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 Crohn's Disease 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 Crohn's disease will be treated with vedolizumab.

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

Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose 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 CD. The drug is tested and approved in adults in approximately 70 countries. 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 CD including exclusive and/or partial enteral nutrition therapy, immunomodulators (e.g., azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists.

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 as:

  • Participants 10 to 15 kg, Vedolizumab 150 mg
  • Participants >15 to <30 kg, Vedolizumab 200 mg
  • Participants ≥30 kg, Vedolizumab 300 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 by weight groups. 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) 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 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 to the high dose in their weight group 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, participants may be eligible to continue receiving vedolizumab in extension study MLN0002-3029. Participants who do not maintain corticosteroid-free clinical response at week 54 will undergo an end-of-study (EOS) or ET visit, and a safety visit 18 weeks after the last dose of vedolizumab followed by 2 years of long term follow-up (up to 104 weeks), in addition these participants will then be eligible to enter study MLN0002-3029 for an observational LTFU period of 2 years after the last dose of study drug.

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
        • Not yet recruiting
        • Children's Hospital at Westmead
        • Contact:
        • Principal Investigator:
          • Shoma Dutt
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • 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
        • Not yet recruiting
        • Royal Children's Hospital Melbourne - PIN
        • Contact:
        • Principal Investigator:
          • George Alex
  • 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
        • Not yet recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • Ilse Hoffman
  • 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
    • Quebec
      • Montreal, Quebec, Canada
        • Not yet recruiting
        • Centre Hospitalier Universitaire Sainte-Justine
        • Contact:
        • Principal Investigator:
          • Colette Deslandres
  • 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
        • Not yet recruiting
        • Henan Children's Hospital(Zhengzhou Children's Hospital)
        • Contact:
        • Principal Investigator:
          • Xiaoqin Li
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Not yet 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
      • Split, Croatia, 21000
        • Recruiting
        • University Hospital Centre 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
        • Contact:
        • Principal Investigator:
          • Jurica Vukovic
  • Czechia
      • Ostrava, Czechia
        • Not yet recruiting
        • Fakultni nemocnice Ostrava
        • Contact:
        • Principal Investigator:
          • Astrida Sulakova
    • Praha, Hlavni Mesto
      • Prague, Praha, Hlavni Mesto, Czechia, 100 34
        • Not yet recruiting
        • Fakultní nemocnice Královské Vinohrady
        • Contact:
        • Principal Investigator:
          • Vladimir Volf
      • Praha, Praha, Hlavni Mesto, Czechia, 140 00
        • Not yet recruiting
        • Fakultní Thomayerova nemocnice
        • Contact:
        • Principal Investigator:
          • Radim Vyhnanek
  • Greece
      • Athens, Greece
        • Recruiting
        • Children's Hospital "Agia Sofia"
        • Contact:
        • Principal Investigator:
          • Alexandra Papadopoulou
      • Thessaloniki, Greece, 564 29
        • Not yet recruiting
        • Ippokratio General Hospital of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Ioannis Xinias
      • Thessaloniki, Greece, 564 29
        • Recruiting
        • Ippokratio General Hospital of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Charalampos Agakidis
    • Attiki
      • Athens, Attiki, Greece, 124 62
        • Recruiting
        • Attikon University General Hospital
        • Contact:
        • Principal Investigator:
          • Vassiliki Papaevangelou
  • Hungary
      • Budapest, Hungary, 1083
        • Not yet recruiting
        • Semmelweis Egyetem
        • Contact:
        • Principal Investigator:
          • Aron Cseh
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
        • Recruiting
        • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
        • Contact:
        • Principal Investigator:
          • Erzsebet Szakos
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Recruiting
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
        • Contact:
        • Principal Investigator:
          • Csaba Bereczki
  • Israel
      • Beer Sheba, Israel, 84101
        • Not yet recruiting
        • Soroka University Medical Centre
        • Contact:
        • Principal Investigator:
          • Baruch Yerushalmi
      • Haifa, Israel, 34362
        • Not yet recruiting
        • Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Corina Hartman
      • Haifa, Israel, 31096
        • Not yet recruiting
        • Rambam Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Ron Shaoul
      • Jerusalem, Israel, 91031
        • Not yet recruiting
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Dan Turner
        • Contact:
      • Jerusalem, Israel, 91120
        • Not yet recruiting
        • Hadassah Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Mordechai Slae
    • 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, 90000
        • Not yet recruiting
        • Tel Aviv Sourasky Medical Center PPDS
        • Principal Investigator:
          • Shlomi Cohen
        • Contact:
  • 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
        • Not yet recruiting
        • Azienda USL di Bologna
        • Contact:
        • Principal Investigator:
          • Patrizia Alvisi
    • Lazio
      • Roma, Lazio, Italy, 161
        • Recruiting
        • Sapienza University of Rome
        • Principal Investigator:
          • Marina Aloi
        • Contact:
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • Not yet recruiting
        • ASST di Monza - Azienda Ospedaliera San Gerardo
        • Contact:
        • Principal Investigator:
          • Roberto Panceri
    • 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
        • Recruiting
        • Kurume University Hospital
        • Contact:
        • Principal Investigator:
          • Tatsuki Mizuochi
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 861-8520
        • Recruiting
        • Japanese Red Cross Kumamoto Hospital
        • Contact:
        • Principal Investigator:
          • Yugo Takaki
    • 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
      • Seongnam, Korea, Republic of, Seoul
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jin Soo Moon
        • Contact:
      • Seoul, Korea, Republic of, 6351
        • Recruiting
        • Samsung Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Yon-Ho Choe
    • 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
      • Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
        • Principal Investigator:
          • Eell Ryoo
  • Lithuania
    • Kauno Apskritis
      • Kaunas, Kauno Apskritis, Lithuania, LT-50161
        • Withdrawn
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
    • Vilniaus Apskritis
      • Vilnius, Vilniaus Apskritis, Lithuania, 8406
        • Withdrawn
        • Vilnius University Hospital Santaros Klinikos
  • Poland
      • Lodz, Poland, 91-738
        • Not yet recruiting
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
        • Contact:
        • Principal Investigator:
          • Ewa Toporowska-Kowalska
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-369
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
        • Contact:
        • Principal Investigator:
          • Andrzej Stawarski
    • 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
        • 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:
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-803
        • Not yet recruiting
        • Copernicus Podmiot Leczniczy Sp. z o.o.
        • Contact:
        • Principal Investigator:
          • Piotr Landowski
    • 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
      • Banska Bystrica, Slovakia, 974 09
        • Terminated
        • Detska fakultna nemocnica s poliklinikou Banska Bystrica
      • Bratislava, Slovakia, 833 40
        • Terminated
        • Narodny ustav detskych chorob
  • Spain
      • Madrid, Spain, 28009
        • Withdrawn
        • Hospital Infantil Universitario Nino Jesus - PIN
      • Malaga, Spain, 29011
        • Withdrawn
        • Hospital Regional Universitario de Malaga - Hospital Materno Infantil
      • Sevilla, Spain, 41013
        • Withdrawn
        • Hospital Universitario Virgen del Rocio - PPDS
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 8950
        • Withdrawn
        • Hospital Sant Joan de Deu - PIN
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Withdrawn
        • Hospital de Sagunto
  • 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, SE5 9RS
        • Not yet recruiting
        • Kings College Hospital
        • Contact:
        • Principal Investigator:
          • Babu Vadamalayan
      • 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
        • Not yet recruiting
        • Phoenix Childrens Hospital
        • Contact:
        • Principal Investigator:
          • Ashish Patel
    • California
      • Los Angeles, California, United States, 90048
        • Withdrawn
        • Cedars Sinai Medical Center
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Rady Childrens Hospital San Diego - PIN
        • Contact:
        • Principal Investigator:
          • Ying Huang
      • San Francisco, California, United States, 94143
        • Withdrawn
        • University of California San Francisco
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Withdrawn
        • I.H.S Health LLC
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • 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:
          • Thirumazhisai S. Gunasekaran
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Withdrawn
        • Riley Hospital for Children
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Maria Oliva-Hemker
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
        • Recruiting
        • MNGI Digestive Health, PA
        • Contact:
        • Principal Investigator:
          • Ramalingam Arumugam
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic - PIN
        • Contact:
        • Principal Investigator:
          • Michael Stephens
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Goryeb Children's Hospital
        • Contact:
        • Principal Investigator:
          • Alycia Leiby
    • New York
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
        • Contact:
        • Principal Investigator:
          • James Markowitz
      • Rochester, New York, United States, 14642
        • Withdrawn
        • University of Rochester Medical Center PPDS
      • Stony Brook, New York, United States, 11794
      • Syracuse, New York, United States, 13202
        • Withdrawn
        • SUNY Upstate Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Thomas Sferra
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15201
        • Not yet recruiting
        • Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Whitney Sunseri
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Withdrawn
        • Hasbro Children's Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Faith Ihekweazu
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • 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

Main Inclusion Criteria:

  1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
  2. The participants weigh ≥10 kg at the time of screening and enrollment into the study.
  3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.
  4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
  5. Participants with 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.
  6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

Main Exclusion Criteria:

  1. Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
  2. Participants with 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.
  3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
  4. The participants has received any live vaccinations within 30 days prior to first dose.
  5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
  6. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections.
  7. Participants with a current diagnosis of indeterminate colitis.
  8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.

  9. 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.

  10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., 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.

  11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA).

    Note: Participants 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 participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  13. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
  14. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
  15. Participants with 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: Induction Period: >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.
Drug: Vedolizumab IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: ≥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 IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: >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 IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: >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 IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: 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 IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Induction Period: 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.
Drug: Vedolizumab IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Induction Period: ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.
Drug: Vedolizumab IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 150 mg
Vedolizumab 150 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 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 IV
Vedolizumab IV
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Maintenance Period: ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 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 high dose arm group will receive vedolizumab 300 mg.
Drug: Vedolizumab IV
Vedolizumab IV
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 Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10
Time Frame: Week 54
Clinical remission is defined by PCDAI score ≤10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of <10 will be consistent with inactive disease, 11 to 30 will indicate mild disease, and >30 will indicate moderate to severe disease. A decrease of 12.5 points is taken as evidence of improvement.
Week 54
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
Time Frame: Week 54
Endoscopic response is defined as at least a 50% reduction in SES-CD score from Baseline. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables (ie, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The segmental SES-CD score is the sum of the 4 variables for each bowel segment and can range from 0 to 12, where each individual variable score ranges from 0 to 3.
Week 54

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
Time Frame: Week 54
Corticosteroid-free clinical remission is where participants achieves corticosteroid-free clinical remission based on PCDAI at Week 54 and has been off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease.
Week 54
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Time Frame: Week 54
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Week 54
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
Time Frame: Week 54
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Week 54
Percentage of Participants With Positive Antivedolizumab Antibodies
Time Frame: Pre-dose (up to 54 weeks)
Pre-dose (up to 54 weeks)
Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
Time Frame: Pre-dose (up to 54 weeks)
Pre-dose (up to 54 weeks)
Percentage of Participants with Clinical Remission at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Time Frame: Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical remission is defined by PCDAI score < 10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT (adjusted for age and sex), ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active 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 AE of special interest (AESI)
Time Frame: From first dose of study drug before each dose on dosing days through the Week 72
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 it is considered related to drug. SAE is 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 congenital anomaly/birth defect and/or is important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to compound or program, for which ongoing monitoring and rapid communication by investigator. AESIs include- opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, infusion-related reactions, hypersensitivity.
From first dose of study drug before each dose on dosing days through the Week 72
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 Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
Time Frame: Week 14
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Week 14
Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
Time Frame: Week 54
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Week 54
Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
Time Frame: Week 54
Sustained clinical and endoscopic remission is where a participant achieved clinical and endoscopic remission based on PCDAI and SES-CD scores at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined as ≤4 with at least a 2-point reduction from Baseline and no sub-score >1 by SES-CD. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Week 54
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Time Frame: Week 14
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Week 14
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
Time Frame: Week 14
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Week 14
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)
Sustained Clinical Response at Week 14 Based on PCDAI Score
Time Frame: Week 14
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Week 14
Sustained Clinical Response at Week 54 Based on PCDAI Score
Time Frame: Week 54
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Week 54
Percentage of Participants with Change in Baseline in Clinical Response at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Time Frame: Baseline, weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical Response is where participants achieves clinical response if PCDAI ≤30 with reduction in the PCDAI of ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Baseline, weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from Baseline in Tanner Stages at Week 54
Time Frame: Week 54
Tanner Stage is used to define physical measurements of sexual development based on external primary and secondary sex characteristics. Female and male participants are evaluated for breast development and genital development respectively and both genders for pubic hair distribution based on a 5-stage scale ranging from Stage I (prepubertal/preadolescent characteristics) to Stage V (mature or adult characteristics).
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 30, 2022

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

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 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLN0002-3025
  • 2020-004301-31 (EudraCT Number)
  • jRCT2071210031 (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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