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

Who is this study for? Pediatric patients with moderately to severely active ulcerative colitis
What treatments are being studied? Vedolizumab
Status: Recruiting
Location: See all (102) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: No
View:

• Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).

• Weighs ≥10 kg at the time of screening and enrollment into the study.

• Has moderately to severely active UC diagnosed at least 1 month before screening, defined by a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore 1 and mandating a score of at least 2).

• Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.

• Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.

• Has extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.

• Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.

Locations
United States
Arizona
Phoenix Childrens Hospital
Not yet recruiting
Phoenix
California
Cedars Sinai Medical Center
Not yet recruiting
Los Angeles
Rady Childrens Hospital San Diego - PIN
Not yet recruiting
San Diego
University of California San Francisco
Recruiting
San Francisco
Florida
I.H.S Health LLC
Recruiting
Kissimmee
Georgia
Childrens Center For Digestive Healthcare
Recruiting
Atlanta
Illinois
Advocate Children's Hospital Park Ridge
Recruiting
Park Ridge
Indiana
Riley Hospital For Children
Recruiting
Indianapolis
Massachusetts
Boston Children's Hospital
Not yet recruiting
Boston
Maryland
Johns Hopkins University
Recruiting
Baltimore
Minnesota
MNGI Digestive Health, PA
Recruiting
Minneapolis
Mayo Clinic - PIN
Recruiting
Rochester
New Jersey
Goryeb Children's Hospital
Recruiting
Morristown
New York
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
Recruiting
Lake Success
University of Rochester Medical Center PPDS
Recruiting
Rochester
Stony Brook University Medical Center
Recruiting
Stony Brook
SUNY Upstate Medical Center
Recruiting
Syracuse
Ohio
University Hospitals Cleveland Medical Center
Recruiting
Cleveland
Pennsylvania
Children's Hospital of Pittsburgh
Not yet recruiting
Pittsburgh
Rhode Island
Hasbro Children's Hospital
Not yet recruiting
Providence
Texas
Texas Children's Hospital
Recruiting
Houston
Virginia
Carilion Children's Tanglewood Center
Recruiting
Roanoke
Other Locations
Australia
Monash Health, Monash Medical Centre
Recruiting
Clayton
Royal Children's Hospital Melbourne - PIN
Recruiting
Parkville
Queensland Childrens Hospital
Recruiting
South Brisbane
Children's Hospital at Westmead
Not yet recruiting
Westmead
Belgium
Universitair Ziekenhuis Brussel - PIN
Not yet recruiting
Brussel
UZ Antwerpen
Not yet recruiting
Edegem
UZ Leuven
Not yet recruiting
Leuven
Canada
University of Alberta Hospital
Not yet recruiting
Edmonton
London Health Sciences Centre
Not yet recruiting
London
Centre Hospitalier Universitaire Sainte-Justine
Not yet recruiting
Montreal
British Columbia Children's Hospital
Not yet recruiting
Vancouver
China
Beijing Children Hospital,Capital Medical University
Recruiting
Beijing
The Children's Hospital Zhejiang UniversitySchool of Medicine
Recruiting
Hangzhou
Children's Hospital of Fudan University
Recruiting
Shanghai
Henan Children's Hospital(Zhengzhou Children's Hospital)
Not yet recruiting
Zhengzhou
Croatia
University Hospital Centre Split
Recruiting
Split
Klinika Za Djecje Bolesti Zagreb
Recruiting
Zagreb
University Hospital Center Zagreb
Recruiting
Zagreb
Greece
Children's Hospital Agia Sofia
Recruiting
Athens
Attikon University General Hospital
Recruiting
Chaidari
Ippokratio General Hospital of Thessaloniki
Recruiting
Thessaloniki
Ippokratio General Hospital of Thessaloniki
Recruiting
Thessaloniki
Hungary
Semmelweis Egyetem
Not yet recruiting
Budapest
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Recruiting
Miskolc
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Recruiting
Szeged
Israel
Soroka University Medical Centre
Recruiting
Be'er Sheva
Carmel Medical Center
Recruiting
Haifa
Rambam Medical Center - PPDS
Recruiting
Haifa
Hadassah Medical Center - PPDS
Recruiting
Jerusalem
Shaare Zedek Medical Center
Recruiting
Jerusalem
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Recruiting
Petah Tiqva
Tel Aviv Sourasky Medical Center PPDS
Recruiting
Tel Aviv
Italy
Azienda USL di Bologna
Not yet recruiting
Bologna
ASST di Monza - Azienda Ospedaliera San Gerardo
Not yet recruiting
Monza
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Not yet recruiting
Napoli
Azienda Ospedaliera Universitaria Federico II
Not yet recruiting
Napoli
Azienda Ospedaliera Universita degli Studi di Padova
Not yet recruiting
Padova
Sapienza University of Rome
Recruiting
Rome
Japan
Juntendo University Hospital
Recruiting
Bunkyo-ku
Japanese Red Cross Kumamoto Hospital
Recruiting
Kumamoto-shi
Kurume University Hospital
Recruiting
Kurume-shi
National Center for Child Health and Development
Recruiting
Setagaya-ku
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Recruiting
Kaunas
Vilnius University Hospital Santaros Klinikos
Recruiting
Vilnius
Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Recruiting
Gdansk
Copernicus Podmiot Leczniczy Sp. z o.o.
Recruiting
Gdansk
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Not yet recruiting
Katowice
Uniwersytecki Szpital Dzieciecy
Not yet recruiting
Krakow
Instytut Centrum Zdrowia Matki Polki
Recruiting
Lodz
Instytut Centrum Zdrowia Matki Polki
Recruiting
Lodz
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Not yet recruiting
Lodz
Korczowski Bartosz, Gabinet Lekarski
Recruiting
Rzeszow
Twoja Przychodnia SCM
Recruiting
Szczecin
Instytut Pomnik Centrum Zdrowia Dziecka
Recruiting
Warszawa
WIP Warsaw IBD Point Profesor Kierkus
Not yet recruiting
Warszawa
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Not yet recruiting
Wroclaw
Republic of Korea
Kyungpook National University Chilgok hospital
Recruiting
Daegu
Gachon University Gil Medical Center
Recruiting
Incheon
Samsung Medical Center - PPDS
Recruiting
Seoul
Seoul National University Hospital
Recruiting
Seoul
Russian Federation
Kazan State Medical University
Not yet recruiting
Kazan'
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Not yet recruiting
Krasnoyarsk
Privolzhsky Research Medical University
Not yet recruiting
Nizhny Novgorod
Medical Company Hepatolog, LLC
Completed
Samara
Slovakia
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Recruiting
Banska Bystrica
Narodny ustav detskych chorob
Not yet recruiting
Bratislava
Spain
Hospital Sant Joan de Deu - PIN
Recruiting
Espluges Del Llobregat
Hospital Infantil Universitario Nino Jesus - PIN
Recruiting
Madrid
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
Recruiting
Malaga
Hospital de Sagunto
Recruiting
Sagunto
Hospital Universitario Virgen del Rocio - PPDS
Recruiting
Sevilla
Ukraine
Municipal Non-profit Enterprise of Kharkiv Regional Council Regional Childrens Clinical Hospital
Not yet recruiting
Kharkiv
Clinic of SI National Scientific Center of Radiological Medicine of NAMS of Ukraine
Not yet recruiting
Kyiv
State Institution Institute of Pediatrics, Obstetrics and Gynecology of NAMS Ukraine
Not yet recruiting
Kyiv
United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Not yet recruiting
Birmingham
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Not yet recruiting
Cardiff
Great Ormond Street Hospital (GOSH)
Not yet recruiting
London
Kings College Hospital
Not yet recruiting
London
Royal Manchester Children's Hospital - PPDS
Not yet recruiting
Manchester
Barts Health NHS Trust
Not yet recruiting
Whitechapel
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: October 19, 2021
Estimated Completion Date: May 30, 2024
Participants
Target number of participants: 120
Treatments
Experimental: Induction Period: Participants ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg were included in this arm.
Experimental: Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm.
Experimental: Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm.
Experimental: Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Experimental: Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Experimental: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Experimental: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Experimental: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Experimental: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Authors
Whitney Sunseri, Marian Pfefferkorn, Joel Rosh, Faith Ihekweazu, Thirumazhisai S. Gunasekaran, Shervin Rabizadeh, Gregory Moore, Maria Oliva-Hemker, Naamah Zitomersky, Syed Lateef, Sofia Verstraete, Juan Olazagasti, Ashish Patel, Zev Davidovics, James Markowitz, Anupama Chawla, Prateek Wali, Ramalingam Arumugam, Shova Subedi, Aelita Kamalova, Xiaoqin Li, Astrida Sulakova, Babu Vadamalayan, Rafeeq Muhammed, Marco Gasparetto, Amar Wahid, Kelsey Jones, Iveta Cierna, Ying Huang, Ruta Kucinskiene, Marta Velasco, Beata Gawdis-Wojnarska, Ewa Toporowska-Kowalska, Michael Stephens, Elisabeth De Greef, Ranka Despot, George Alex, Jurica Vukovic, Aron Cseh, Piotr Landowski, Erzsebet Szakos, Vladimir Kopeykin, Viktor Zygalo, Alejandro Rodriguez Martinez, Valentyna Berezenko, Olena Omelchenko, Andrew (Sunday) Fagbemi, Takahiro Kudo, Laura Sanchis Artero, Vladimir Volf, Viktoria Panphilova, Mara Cananzi, Katsuhiro Arai, Ron Shaoul, Jonathan Moses, Corina Hartman, Ilse Hoffman, Sanja Kolacek, Monika Meglicka, Radim Vyhnanek, Caterina Strisciuglio, Alexandra Papadopoulou, Patrizia Alvisi, Jaroslaw Kierkus, Kevan Jacobson, Andrzej Stawarski, Ioannis Xinias, Colette Deslandres, Erasmo Miele, Charalampos Agakidis, Marina Aloi, Eell Ryoo, Shoma Dutt, Csaba Bereczki, Iveta Valachova, Elzbieta Czkwianianc, Raanan Shamir, Els Van de Vijver, Tatsuki Mizuochi, Peter Lewindon, Vaidotas Urbonas, Yon-Ho Choe, Kinga Kowalska-Duplaga, Hien Huynh, Ben Kang, Jie Wu, Dan Turner, Urszula Grzybowska-Chlebowczyk, Roberto Panceri, Victor Navas Lopez, Vassiliki Papaevangelou, Bartosz Korczowski, Shlomi Cohen, Kevin Bax, Yugo Takaki, Jin Soo Moon, Jie Chen, Baruch Yerushalmi, Javier Martin de Carpi
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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