Crohn's Disease (CD)Phase 3NCT04779320
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
A Phase 3 study testing Vedolizumab IV in people with Crohn's Disease (CD), run by Takeda at 96 sites in 18 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Crohn's Disease (CD)
- What is being tested?
- Vedolizumab IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 96 sitesin 18 countries
- Study dates
- 10 Feb 2022to 13 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
- The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
- The participants weigh ≥10 kg at the time of screening and enrollment into the study.
- 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.
- 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.
- 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.
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
Main Exclusion Criteria:
- 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.
- 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.
- 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.
- The participants has received any live vaccinations within 30 days prior to first dose.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
- 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.
- Participants with a current diagnosis of indeterminate colitis.
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
- 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.
- 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.
- 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]).
- The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- 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.
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
- Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
Other inclusion/exclusion criteria may apply.
Trial locations and contacts
96 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
96 sites in 18 countries
United States22 sites, 15 recruiting
- Recruiting
Childrens Center For Digestive Healthcare
Atlanta, Georgia, 30342
Site Contact, 404-257-0799, bgold@gicareforkids.com
Benjamin Gold
- Not yet recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Site Contact, 141-095-5876 ext. 9, moliva@jhmi.edu
Maria Oliva-Hemker
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Site Contact, 617-355-2962, naamah.zitomersky@childrens.harvard.edu
Naamah Zitomersky
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Site Contact, 216-286-0221, thomas.sferra@uhhospitals.org
Thomas Sferra
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Site Contact, 832-824-1000, faith.ihekweazu@bcm.edu
Faith Ihekweazu
- Withdrawn
Riley Hospital For Children
Indianapolis, Indiana, 46202
- Withdrawn
I.H.S Health LLC
Kissimmee, Florida, 34741
- Withdrawn
Cedars Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
MNGI Digestive Health, PA
Minneapolis, Minnesota, 55413
Site Contact, 612-813-7240, Ramalingam.Arumugam@mngi.com
Ramalingam Arumugam
- Recruiting
Goryeb Children's Hospital
Morristown, New Jersey, 07960
Site Contact, 973-971-5676, alycia.leiby@atlantichealth.org
Alycia Leiby
- Recruiting
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
New Hyde Park, New York, 11042
Site Contact, 516-472-3650, jmarkowi2@nshs.edu
James Markowitz
- Recruiting
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, 60068
Site Contact, 847-723-7700, Ts.Gunasekaran@aah.org
Thirumazhisai S. Gunasekaran
- Not yet recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Site Contact, 602-933-0940, apatel12@phoenixchildrens.com
Ashish Patel
- Not yet recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15201
Site Contact, 412-692-6558, whitney.sunseri@chp.edu
Whitney Sunseri
- Withdrawn
Hasbro Children's Hospital
Providence, Rhode Island, 02903
- Recruiting
Carilion Children's Tanglewood Center
Roanoke, Virginia, 24018
Site Contact, 540-985-9832, jcolazagasti@carilionclinic.org
Juan Olazagasti
- Not yet recruiting
Mayo Clinic - PIN
Rochester, Minnesota, 55905
Site Contact, 507-266-0114, stephens.michael@mayo.edu
Michael Stephens
- Withdrawn
University of Rochester Medical Center PPDS
Rochester, New York, 14642
- Not yet recruiting
Rady Childrens Hospital San Diego - PIN
San Diego, California, 92123
Site Contact, 381-688-2247 ext. +861, yhuang815@163.com
Ying Huang
- Withdrawn
University of California San Francisco
San Francisco, California, 94143
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Contact, 888-888-8888, anupama.chawla@stonybrookmedicine.edu
Anupama Chawla
- Withdrawn
SUNY Upstate Medical Center
Syracuse, New York, 13202
Poland10 sites, 10 recruiting
- Not yet recruiting
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-803
Site Contact, +48583022591, pland@gumed.edu.pl
Piotr Landowski
- Not yet recruiting
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, 40-752
Site Contact, +48322071700, urszulachlebowczyk@wp.pl
Urszula Grzybowska-Chlebowczyk
- Not yet recruiting
Uniwersytecki Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, 30-663
Site Contact, +48123339330, kingakd@mp.pl
Kinga Kowalska-Duplaga
- Not yet recruiting
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, 91-738
Site Contact, +48426177792, ewa.toporowska-kowalska@umed.lodz.pl
Ewa Toporowska-Kowalska
- Not yet recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338
Site Contact, +48422711341, elcia@friend.pl
Elzbieta Czkwianianc
- Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, 35-302
Site Contact, +48177404065, korczowski@op.pl
Bartosz Korczowski
- Recruiting
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, 71-434
Site Contact, +48914332919, gawdis@twojaprzychodnia.com
Beata Gawdis-Wojnarska
- Not yet recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, 00-728
Site Contact, +48226580456, m.meglicka@wip.waw.pl
Monika Meglicka
- Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, 04-736
Site Contact, +486002111648, J.KIERKUS@IPCZD.PL
Jaroslaw Kierkus
- Not yet recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-369
Site Contact, +48604213864, as.stawarski@poczta.onet.pl
Andrzej Stawarski
Israel7 sites, 7 recruiting
- Not yet recruiting
Soroka University Medical Centre
Beersheba, 84101
Site Contact, +97286400653, baruchy@clalit.org.il
Baruch Yerushalmi
- Not yet recruiting
Rambam Medical Center - PPDS
Haifa, 31096
Site Contact, +97248543388, r_shaoul@rambam.health.gov.il
Ron Shaoul
- Not yet recruiting
Carmel Medical Center
Haifa, 34362
Site Contact, +4056303, corinah@clalit.org.il
Corina Hartman
- Not yet recruiting
Tel Aviv Sourasky Medical Center PPDS
Jerusalem, Jerusalem, 90000
Site Contact, +972524266988, shlomico@tlvmc.gov.il
Shlomi Cohen
- Not yet recruiting
Shaare Zedek Medical Center
Jerusalem, 91031
Site Contact, +97226666482, turnerd@szmc.org.il
Dan Turner
- Not yet recruiting
Hadassah Medical Center - PPDS
Jerusalem, 91120
Site Contact, +97226778637, mord@hadassah.org.il
Mordechai Slae
- Not yet recruiting
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Central District, 49202
Site Contact, +97239253672, raanan@shamirmd.com
Raanan Shamir
Italy6 sites, 6 recruiting
- Not yet recruiting
Azienda USL di Bologna
Bologna, Emilia-Romagna, 40133
Site Contact, +390516478437, patrizia.alvisi@ausl.bologna.it
Patrizia Alvisi
- Not yet recruiting
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardy, 20900
Site Contact, +398888888888, r.panceri@asst-monza.it
Roberto Panceri
- Not yet recruiting
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Naples, Campania, 80131
Site Contact, +390815665464, caterina.strisciuglio@unicampania.it
Caterina Strisciuglio
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131
Site Contact, +390817464565, erasmo.miele@unina.it
Erasmo Miele
- Not yet recruiting
Universita degli Studi di Padova
Padova, Veneto, 35122
Site Contact, +390498213517, maracananzi@yahoo.com
Mara Cananzi
- Recruiting
Sapienza University of Rome
Rome, Lazio, 161
Site Contact, +390649979387, marina.aloi@gmail.com
Marina Aloi
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, West Midlands, B4 6NH
Site Contact, +4401213338705, rafeeq.muhammed@nhs.net
Rafeeq Muhammed
- Not yet recruiting
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Cardiff, South Glamorgan, CF14 4XW
Site Contact, +448888888888, amar.wahid@wales.nhs.uk
Amar Wahid
- Not yet recruiting
Kings College Hospital
London, London, City of, SE5 9RS
Site Contact, +442032991674, babu.vadamalayan@nhs.net
Babu Vadamalayan
- Not yet recruiting
Great Ormond Street Hospital (GOSH)
London, London, City of, WC1N 3AJ
Site Contact, +447779142231, kelsey.jones@gosh.nhs.uk
Kelsey Jones
- Not yet recruiting
Barts Health NHS Trust
London, E1 1BB
Site Contact, +448888888888, marco.gasparetto@nhs.net
Marco Gasparetto
- Not yet recruiting
Royal Manchester Children's Hospital - PPDS
Manchester, M27 4HA
Site Contact, +441617012371, andrew.fagbemi@mft.nhs.uk
Andrew (Sunday) Fagbemi
Spain5 sites
- Withdrawn
Hospital Sant Joan de Deu - PIN
Esplugues de Llobregat, Barcelona, 8950
- Withdrawn
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, 28009
- Withdrawn
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
Málaga, 29011
- Withdrawn
Hospital de Sagunto
Sagunto, Valencia, 46520
- Withdrawn
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Australia4 sites, 4 recruiting
- Not yet recruiting
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
Site Contact, +61395943177, Gregory.moore@monash.edu
Gregory Moore
- Not yet recruiting
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, 3052
Site Contact, +0393455060, george.alex@rch.org.au
George Alex
- Recruiting
Queensland Childrens Hospital
South Brisbane, Queensland, 4101
Site Contact, +61730684502, peter.lewindon@health.qld.gov.au
Peter Lewindon
- Not yet recruiting
Children's Hospital at Westmead
Westmead, New South Wales, 2145
Site Contact, +61298453999, shoma.dutt@health.nsw.gov.au
Shoma Dutt
Canada4 sites, 4 recruiting
- Not yet recruiting
University of Alberta Hospital
Edmonton, Alberta, AB T6G 2B7
Site Contact, (780) 248-5420, hien.huynh@ualberta.ca
Hien Huynh
- Not yet recruiting
London Health Sciences Centre
London, Ontario, N6A 4G5
Site Contact, (519) 685-8500 x56836, kevin.bax@lhsc.on.ca
Kevin Bax
- Not yet recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec
Site Contact, (514) 345-4931, colette.deslandres@umontreal.ca
Colette Deslandres
- Not yet recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H3V4
Site Contact, (604) 377-1831, kjacobson@cw.bc.ca
Kevan Jacobson
China4 sites, 4 recruiting
- Not yet recruiting
Beijing Children Hospital,Capital Medical University
Beijing, Beijing Municipality, 100045
Site Contact, +8618940251108, wujiedoc@163.com
Jie Wu
- Not yet recruiting
The Children's Hospital Zhejiang UniversitySchool of Medicine
Hangzhou, Zhejiang, 310003
Site Contact, +8613858032920, hzcjie@163.com
Jie Chen
- Not yet recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Site Contact, +8613816882247, yhuang815@163.com
Ying Huang
- Not yet recruiting
Henan Children's Hospital(Zhengzhou Children's Hospital)
Zhengzhou, Henan, 450000
Site Contact, +8615890105818, lixiaoqinys@126.com
Xiaoqin Li
Greece4 sites, 4 recruiting
- Recruiting
Attikon University General Hospital
Athens, Attica, 124 62
Site Contact, +302105832228, vpapaev@gmail.com
Vassiliki Papaevangelou
- Recruiting
Children's Hospital "Agia Sofia"
Athens
Site Contact, +302107467359, a.papadopoulou@paidon-agiasofia.gr
Alexandra Papadopoulou
- Not yet recruiting
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 564 29
Site Contact, +302310992877, xinias@email.com
Ioannis Xinias
- Recruiting
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 564 29
Site Contact, +306947687799, cagakidis@gmail.com
Charalampos Agakidis
Japan4 sites, 4 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431
Site Contact, +81338133111, t-kudo@juntendo.ac.jp
Takahiro Kudo
- Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520
Site Contact, +81963842111, tturmso@yahoo.co.jp
Yugo Takaki
- Recruiting
Kurume University Hospital
Kurume-Shi, Hukuoka, 830-0011
Site Contact, +81942353311, mizuochi_tatsuki@kurume-u.ac.jp
Tatsuki Mizuochi
- Recruiting
National Center for Child Health and Development
Setagaya-Ku, Tokyo, 157-8535
Site Contact, +81334160181, arai-k@ncchd.go.jp
Katsuhiro Arai
South Korea4 sites, 4 recruiting
- Recruiting
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, 41404
Site Contact, +82532003780, benkang@knu.ac.kr
Ben Kang
- Recruiting
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, 21565
Site Contact, +82324603213, ryoo518@gilhospital.com
Eell Ryoo
- Recruiting
Seoul National University Hospital
Seongnam, Seoul
Site Contact, mjschj@snu.ac.kr
Jin Soo Moon
- Recruiting
Samsung Medical Center - PPDS
Seoul, 6351
Site Contact, +82234103901, smc_yhc@naver.com
Yon-Ho Choe
Belgium3 sites, 3 recruiting
- Not yet recruiting
UZ Antwerpen
Edegem, Antwerpen, 2650
Site Contact, +3238213810, els.vandevijver@uza.be
Els Van de Vijver
- Not yet recruiting
Universitair Ziekenhuis Brussel - PIN
Jette, Brussels Capital, 1090
Site Contact, +32485022839, elisabeth.degreef@uzbrussel.be
Elisabeth De Greef
- Not yet recruiting
UZ Leuven
Leuven, Vlaams Brabant, 3000
Site Contact, +016343843, ilse.hoffman@uzleuven.be
Ilse Hoffman
Croatia3 sites, 3 recruiting
- Recruiting
University Hospital Centre Split
Split, 21000
Site Contact, +38598432200, ranka.despot11@gmail.com
Ranka Despot
- Recruiting
Klinika Za Djecje Bolesti Zagreb
Zagreb, City of Zagreb, 10000
Site Contact, +38514600291, ivahojsak@gmail.com
Iva Hojsak
- Recruiting
University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000
Site Contact, +38598469865, juricav1961@yahoo.com
Jurica Vukovic
Czechia3 sites, 3 recruiting
- Not yet recruiting
Fakultni nemocnice Ostrava
Ostrava
Site Contact, +420597371111, astrida.sulakova@fno.cz
Astrida Sulakova
- Not yet recruiting
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, 100 34
Site Contact, +420267163731, vladimir.volf@fnkv.cz
Vladimir Volf
- Not yet recruiting
Fakultni Thomayerova Nemocnice
Prague, Praha, Hlavni Mesto, 140 00
Site Contact, +420261083798, radim.vyhnanek@ftn.cz
Radim Vyhnanek
Hungary3 sites, 3 recruiting
- Not yet recruiting
Semmelweis Egyetem
Budapest, 1083
Site Contact, +36208258186, cseharon@gmail.com
Aron Cseh
- Recruiting
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Borsod-Abauj Zemplen county, 3526
Site Contact, +3646515200, szakos.iiigyek@bazmkorhaz.hu
Erzsebet Szakos
- Recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6720
Site Contact, +36302497404, office.pedia@med.u-szeged.hu
Csaba Bereczki
Lithuania2 sites
- Withdrawn
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, LT-50161
- Withdrawn
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, 8406
Slovakia2 sites
- Terminated
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, 974 09
- Terminated
Narodny ustav detskych chorob
Bratislava, 833 40
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn's Disease (CD)
- Being tested
- Vedolizumab IV
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab IVDrug
Also called ENTYVIO, KYNTELES, MLN0002
Vedolizumab IV
| Study group | Role | What they receive |
|---|---|---|
| Induction Period: 10 to 15 kg, Vedolizumab 150 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Induction Period: >15 to <30 kg, Vedolizumab 200 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Induction Period: ≥30 kg, Vedolizumab 300 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Maintenance Period: 10 to 15 kg Vedolizumab 150 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Maintenance Period: 10 to 15 kg Vedolizumab 100 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Maintenance Period: >15 to <30 kg Vedolizumab 100 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Maintenance Period: ≥30 kg, Vedolizumab 300 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
| Maintenance Period: ≥30 kg: Vedolizumab 150 mg | Experimental | 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. Receives: Drug: Vedolizumab IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10
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.
Measured: Week 54
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
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.
Measured: Week 54
Secondary outcomes (19)
Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
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.
Measured: Week 14
Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
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.
Measured: Week 54
Percentage of Participants with Sustained Clinical and Endoscopic Remission at 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.
Measured: Week 54
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
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.
Measured: Week 54
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
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.
Measured: Week 14
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
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.
Measured: Week 54
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
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.
Measured: Week 14
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
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.
Measured: Week 54
Serum Trough Concentrations of Vedolizumab Over Time
Measured: Predose and postdose at multiple time points (up to 54 weeks)
Percentage of Participants With Positive Antivedolizumab Antibodies
Measured: Pre-dose (up to 54 weeks)
Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
Measured: Pre-dose (up to 54 weeks)
Sustained Clinical Response at Week 14 Based on PCDAI Score
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.
Measured: Week 14
Sustained Clinical Response at Week 54 Based on PCDAI Score
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.
Measured: Week 54
Percentage of Participants with Clinical Remission at 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.
Measured: Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Percentage of Participants with Change in Baseline in Clinical Response at 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.
Measured: Baseline, 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)
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.
Measured: From first dose of study drug before each dose on dosing days through the Week 72
Change from Baseline in Weight
Change from in Baseline in weight will be calculated as: Weight at each study visit (up to Week 54) - Weight at Baseline.
Measured: Baseline up to Week 54
Change from Baseline in Linear Growth Z-score
Linear growth Z-score will be calculated as: Z-score = (observed value - median value of the reference population)/ standard deviation value of reference population.
Measured: Baseline up to Week 54
Change from Baseline in Tanner Stages at 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).
Measured: Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start10 Feb 2022
- Primary completion13 Sep 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779320
- Sponsor's protocol ID
- MLN0002-3025
- Other IDs
- 2020-004301-31, jRCT2071210031, 2023-509045-13-00, 2023
- Status last verified
- Apr 2026
- First submitted
- 1 Mar 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04779320
- Acronym / sponsor ID
- MLN0002-3025
- Conditions
- Crohn's Disease (CD)
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 13 Sep 2027 (estimated)
- Study completion
- 13 Sep 2027 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Induction Period: 10 to 15 kg, Vedolizumab 150 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Induction Period: >15 to <30 kg, Vedolizumab 200 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Induction Period: ≥30 kg, Vedolizumab 300 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Maintenance Period: 10 to 15 kg Vedolizumab 150 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Maintenance Period: 10 to 15 kg Vedolizumab 100 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Maintenance Period: >15 to <30 kg Vedolizumab 100 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Maintenance Period: ≥30 kg, Vedolizumab 300 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
| Maintenance Period: ≥30 kg: Vedolizumab 150 mg | Experimental | Drug: Vedolizumab IVVedolizumab 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab IVAlso: ENTYVIO, KYNTELES, MLN0002Vedolizumab IV | Drug | Induction Period: 10 to 15 kg, Vedolizumab 150 mg, Induction Period: >15 to <30 kg, Vedolizumab 200 mg, Induction Period: ≥30 kg, Vedolizumab 300 mg, Maintenance Period: 10 to 15 kg Vedolizumab 100 mg, Maintenance Period: 10 to 15 kg Vedolizumab 150 mg, Maintenance Period: >15 to <30 kg Vedolizumab 100 mg, Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg, Maintenance Period: ≥30 kg, Vedolizumab 300 mg, Maintenance Period: ≥30 kg: Vedolizumab 150 mg |
Primary outcome
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.
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.
19 secondary outcomes
Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
Time frame: 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
Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
Time frame: Week 54
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
Time frame: Week 54
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Time frame: Week 14
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Time frame: Week 54
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
Time frame: Week 14
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
Time frame: Week 54
Serum Trough Concentrations of Vedolizumab Over Time
Time frame: Predose and postdose at multiple time points (up to 54 weeks)
Percentage of Participants With Positive Antivedolizumab Antibodies
Time frame: Pre-dose (up to 54 weeks)
Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
Time frame: Pre-dose (up to 54 weeks)
Sustained Clinical Response at Week 14 Based on PCDAI Score
Time frame: Week 14
Sustained Clinical Response at Week 54 Based on PCDAI Score
Time frame: Week 54
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
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
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
Change from Baseline in Weight
Time frame: Baseline up to Week 54
Change from Baseline in Linear Growth Z-score
Time frame: Baseline up to Week 54
Change from Baseline in Tanner Stages at Week 54
Time frame: Week 54
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
96 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vedolizumab IV in people with Crohn's Disease (CD), run by Takeda at 96 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, Poland, Israel, Italy, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10 (time frame: Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.