A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
Study Purpose
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.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 2 Years - 17 Years |
| Gender | All |
Inclusion Criteria:
1. Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC). 2. Weighs ≥10 kg at the time of screening and enrollment into the study. 3. Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy. 4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids. 5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum. 6. Has extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening. 7. Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.Exclusion Criteria:
1. Has previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab. 2. Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period. 3. Has active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease. 4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug. 5. Has received any live vaccinations within 30 days prior to first dose of study drug. 6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study. 7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine. 8. Participants with a current diagnosis of indeterminate colitis. 9. Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease. 10. Participant with active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening period that is positive, defined as:- - Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR.
- - A TB skin test reaction ≥5 mm.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04779307 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Takeda |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Australia, Belgium, Canada, China, Croatia, Czechia, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Colitis, Ulcerative |
| Study Website: | View Trial Website |
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC. Participants to be enrolled must have failed response to, lost response to, or been intolerant to at least 1 of the current standard of care (SOC) induction and maintenance therapies for UC including immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists (eg, infliximab, adalimumab). The study will enroll approximately 120 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline:
- - Participants ≥30 kg, Vedolizumab 300 mg.
- - Participants >15 to <30 kg, Vedolizumab 200 mg.
- - Participants 10 to 15 kg, Vedolizumab 150 mg.
- - Participants ≥30 kg, Vedolizumab 300 mg (High dose) or 150 mg (Low dose) - Participants >15 to <30 kg, Vedolizumab 200 mg (High dose) or 100 mg (Low dose) - Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) or 100 mg (Low dose) The dose will remain blinded to the participant and study doctor during the study (unless there is an urgent medical need).
Arms
Experimental: Induction Period: Participants ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm.
Experimental: Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg are included in this arm.
Experimental: Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.
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.
Interventions
Drug: - Vedolizumab
Vedolizumab IV infusion.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Status
Not yet recruiting
Address
Cedars Sinai Medical Center
Los Angeles, California, 90048
Status
Not yet recruiting
Address
Rady Childrens Hospital San Diego - PIN
San Diego, California, 92123
Status
Recruiting
Address
University of California San Francisco
San Francisco, California, 94158
Status
Recruiting
Address
I.H.S Health LLC
Kissimmee, Florida, 34741
Status
Recruiting
Address
Childrens Center For Digestive Healthcare
Atlanta, Georgia, 30342
Status
Recruiting
Address
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, 60068
Status
Recruiting
Address
Riley Hospital For Children
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Johns Hopkins University
Baltimore, Maryland, 21287
Status
Not yet recruiting
Address
Boston Children's Hospital
Boston, Massachusetts, 02115
Status
Recruiting
Address
MNGI Digestive Health, PA
Minneapolis, Minnesota, 55413
Status
Recruiting
Address
Mayo Clinic - PIN
Rochester, Minnesota, 55905
Status
Recruiting
Address
Goryeb Children's Hospital
Morristown, New Jersey, 07960
Status
Recruiting
Address
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
Lake Success, New York, 11042
Status
Recruiting
Address
University of Rochester Medical Center PPDS
Rochester, New York, 14642
Status
Recruiting
Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
Status
Recruiting
Address
SUNY Upstate Medical Center
Syracuse, New York, 13202
Status
Recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Status
Not yet recruiting
Address
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Status
Not yet recruiting
Address
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Status
Recruiting
Address
Texas Children's Hospital
Houston, Texas, 77030
Status
Recruiting
Address
Carilion Children's Tanglewood Center
Roanoke, Virginia, 24018
International Sites
Status
Not yet recruiting
Address
Children's Hospital at Westmead
Westmead, New South Wales, 2145
Status
Recruiting
Address
Queensland Childrens Hospital
South Brisbane, Queensland, 4101
Status
Recruiting
Address
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
Status
Recruiting
Address
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, 3052
Status
Not yet recruiting
Address
UZ Antwerpen
Edegem, Antwerpen, 2650
Status
Not yet recruiting
Address
Universitair Ziekenhuis Brussel - PIN
Brussel, , 1090
Status
Not yet recruiting
Address
UZ Leuven
Leuven, , 3000
Status
Not yet recruiting
Address
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Status
Not yet recruiting
Address
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Status
Not yet recruiting
Address
London Health Sciences Centre
London, Ontario, N6A 5W9
Status
Not yet recruiting
Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Status
Recruiting
Address
Beijing Children Hospital,Capital Medical University
Beijing, Beijing, 100045
Status
Not yet recruiting
Address
Henan Children's Hospital(Zhengzhou Children's Hospital)
Zhengzhou, Henan, 450000
Status
Recruiting
Address
Children's Hospital of Fudan University
Shanghai, Shanghai, 201102
Status
Recruiting
Address
The Children's Hospital Zhejiang UniversitySchool of Medicine
Hangzhou, Zhejiang, 310003
Status
Recruiting
Address
Klinika Za Djecje Bolesti Zagreb
Zagreb, Grad Zagreb, 10000
Status
Recruiting
Address
University Hospital Center Zagreb
Zagreb, Grad Zagreb, 10000
Status
Recruiting
Address
University Hospital Centre Split
Split, , 21000
Status
Recruiting
Address
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, 100 34
Status
Recruiting
Address
Fakultni Thomayerova Nemocnice
Praha, Praha, Hlavni Mesto, 140 00
Status
Recruiting
Address
Fakultni nemocnice Ostrava
Ostrava, ,
Status
Recruiting
Address
Attikon University General Hospital
Chaidari, Attiki, 124 62
Status
Recruiting
Address
Children's Hospital "Agia Sofia"
Athens, ,
Status
Recruiting
Address
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , 546 29
Status
Recruiting
Address
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , 54642
Status
Recruiting
Address
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Borsod-Abauj-Zemplen, 3526
Status
Recruiting
Address
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrad, 6720
Status
Not yet recruiting
Address
Semmelweis Egyetem
Budapest, , 1083
Status
Recruiting
Address
Soroka University Medical Centre
Be'er Sheva, , 84101
Status
Recruiting
Address
Rambam Medical Center - PPDS
Haifa, , 3109601
Status
Recruiting
Address
Carmel Medical Center
Haifa, , 3436212
Status
Recruiting
Address
Shaare Zedek Medical Center
Jerusalem, , 9103102
Status
Recruiting
Address
Hadassah Medical Center - PPDS
Jerusalem, , 91120
Status
Recruiting
Address
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tiqva, , 4920235
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, , 6423906
Status
Not yet recruiting
Address
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Napoli, Campania, 80131
Status
Not yet recruiting
Address
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131
Status
Not yet recruiting
Address
Azienda USL di Bologna
Bologna, Emilia-Romagna, 40133
Status
Not yet recruiting
Address
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardia, 20900
Status
Not yet recruiting
Address
Azienda Ospedaliera Universita degli Studi di Padova
Padova, Veneto, 35128
Status
Recruiting
Address
Sapienza University of Rome
Rome, , 161
Status
Recruiting
Address
Kurume University Hospital
Kurume-Shi, Hukuoka, 830-0011
Status
Recruiting
Address
Japanese Red Cross Kumamoto Hospital
Kumamoto-shi, Kumamoto, 861-8520
Status
Recruiting
Address
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431
Status
Recruiting
Address
National Center for Child Health and Development
Setagaya-Ku, Tokyo, 157-8535
Status
Recruiting
Address
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080
Status
Recruiting
Address
Kyungpook National University Chilgok hospital
Daegu, , 41404
Status
Recruiting
Address
Gachon University Gil Medical Center
Incheon, , 21565
Status
Recruiting
Address
Samsung Medical Center - PPDS
Seoul, , 6351
Status
Recruiting
Address
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kauno Apskritis, LT-50161
Status
Recruiting
Address
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilniaus Apskritis, 8406
Status
Not yet recruiting
Address
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Dolnoslaskie, 50-369
Status
Recruiting
Address
Instytut Centrum Zdrowia Matki Polki
Lodz, Lodzkie, 93-316
Status
Recruiting
Address
Instytut Centrum Zdrowia Matki Polki
Lodz, Lodzkie, 93-338
Status
Not yet recruiting
Address
Uniwersytecki Szpital Dzieciecy
Krakow, Malopolskie, 30-663
Status
Not yet recruiting
Address
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, Mazowieckie, 00-728
Status
Recruiting
Address
Instytut Pomnik Centrum Zdrowia Dziecka
Warszawa, Mazowieckie, 04-736
Status
Recruiting
Address
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Pomorskie, 80-803
Status
Not yet recruiting
Address
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Slaskie, 40-752
Status
Recruiting
Address
Twoja Przychodnia SCM
Szczecin, Zachodniopomorskie, 71-434
Status
Recruiting
Address
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, , 80-803
Status
Not yet recruiting
Address
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, , 91-738
Status
Recruiting
Address
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, , 35-302
Status
Not yet recruiting
Address
Kazan State Medical University
Kazan', Tatarstan, Respublika, 420012
Status
Not yet recruiting
Address
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Krasnoyarsk, , 660074
Status
Not yet recruiting
Address
Privolzhsky Research Medical University
Nizhny Novgorod, , 603005
Status
Completed
Address
Medical Company Hepatolog, LLC
Samara, , 443045
Status
Recruiting
Address
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banska Bystrica, , 974 09
Status
Not yet recruiting
Address
Narodny ustav detskych chorob
Bratislava, , 833 40
Status
Recruiting
Address
Hospital Sant Joan de Deu - PIN
Espluges Del LLobregat, Barcelona, 8950
Status
Recruiting
Address
Hospital de Sagunto
Sagunto, Valencia, 46520
Status
Recruiting
Address
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, , 28009
Status
Recruiting
Address
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
Malaga, , 29011
Status
Recruiting
Address
Hospital Universitario Virgen del Rocio - PPDS
Sevilla, , 41013
Status
Not yet recruiting
Address
Municipal Non-profit Enterprise of Kharkiv Regional Council Regional Childrens Clinical Hospital
Kharkiv, Kharkivs'ka Oblast, 61093
Status
Not yet recruiting
Address
Clinic of SI National Scientific Center of Radiological Medicine of NAMS of Ukraine
Kyiv, , 3115
Status
Not yet recruiting
Address
State Institution Institute of Pediatrics, Obstetrics and Gynecology of NAMS Ukraine
Kyiv, , 4050
Status
Not yet recruiting
Address
Great Ormond Street Hospital (GOSH)
London, London, City Of, WC1N 3AJ
Status
Not yet recruiting
Address
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Cardiff, South Glamorgan, CF14 4XW
Status
Not yet recruiting
Address
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, , B4 6NH
Status
Not yet recruiting
Address
Kings College Hospital
London, ,
Status
Not yet recruiting
Address
Royal Manchester Children's Hospital - PPDS
Manchester, , M27 4HA
Status
Not yet recruiting
Address
Barts Health NHS Trust
Whitechapel, , E1 1FR
